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| Name | Class |
|---|---|
| Sunstar, Inc. | INDUSTRY |
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With poorly controlled diabetes, periodontal status often worsens, and with severe periodontal conditions there is often poorer glycemic control. There are few published reports investigating the efficacy of periodontal therapy in diabetics and fewer that include evaluation of the oral microbial profiles (the microbiome). The investigators will examine systemic changes in diabetes status and microbiome influences on clinical response to periodontal therapy in a randomized clinical trial of participants with and without diabetes and with periodontal disease. Two different treatments will be used:
With poorly controlled diabetes, periodontal disease worsens, and with severe periodontal conditions, there is often poorer glycemic control. Published papers conclude that periodontal treatment leads to a reduction in hemoglobin A1c; however, other studies show limited or no improvement. Some patients do not respond well to professional periodontal therapy, even without diabetes, which could be related to poor oral hygiene and/or host factors including microbial profiles. There are few published papers investigating the efficacy of periodontal therapy in diabetics and fewer that include assessment of the oral microbiome. The investigators will examine systemic changes in diabetes status and microbiome influences on clinical response to periodontal therapy in a randomized clinical trial. It has been shown that chlorhexidine gluconate rinse leads to significant clinical improvement over standard periodontal therapy alone, and interdental tooth cleaners remove more dental plaque (leading to reduced gingival inflammation) effectively than brushing alone. Therefore, in this study, standard periodontal therapy, scaling and root planning (SRP) will be provided alone, or SRP plus supportive periodontal therapy (SPT), the use of chlorhexidine gluconate rinse (Paroex®) and a rubber interdental bristle cleaner (Soft-Picks), to diabetics and non-diabetics with periodontal disease to determine the differences in response between the groups.
The main aim of this study is to evaluate the effects of SRP alone versus SRP+SPT on clinical, microbiological and immunological status of subjects with and without type 2 diabetes and with periodontal disease. A clearer understanding of how periodontal therapy affects diabetes status could lead to the development of novel new targeted therapies of both periodontal disease and diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Diabetic + SRP + SPT | Experimental | The first group, A, includes diabetics with periodontal disease; they will receive standard therapy, scaling & root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks. |
|
| B: Non-Diabetic + SRP + SPT | Experimental | The second group, B, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling & root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks. |
|
| C: Diabetic + SRP | Active Comparator | The third group, C, includes diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP). |
|
| D: Non-Diabetic + SRP | Active Comparator | The second group, D, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine gluconate oral rinse | Drug | Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline | Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline | Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured | Baseline to 3 months |
| Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert E Schifferle, DDS, PhD | University at Buffalo, State University of New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo | Buffalo | New York | 14214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2209317 | Background | Nelson RG, Shlossman M, Budding LM, Pettitt DJ, Saad MF, Genco RJ, Knowler WC. Periodontal disease and NIDDM in Pima Indians. Diabetes Care. 1990 Aug;13(8):836-40. doi: 10.2337/diacare.13.8.836. | |
| 9527565 | Background | Taylor GW, Burt BA, Becker MP, Genco RJ, Shlossman M, Knowler WC, Pettitt DJ. Non-insulin dependent diabetes mellitus and alveolar bone loss progression over 2 years. J Periodontol. 1998 Jan;69(1):76-83. doi: 10.1902/jop.1998.69.1.76. |
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Of 116 enrolled participants, 114 met inclusion criteria and were randomized for treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | A: SRP + SPT | The first group, A, includes diabetics and non-diabetics with periodontal disease; they will receive standard therapy, scaling & root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks. Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops. Scaling & Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums. Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores. |
| FG001 | B: SRP | The second group, B, includes diabetics and non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP). Scaling & Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
In this study, unit participant is assigned to Arms/Groups in all measures. For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each subject. And the outcome of each participant were analyzed in each Aim.
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| ID | Title | Description |
|---|---|---|
| BG000 | Diabetic + SRP + SPT | The group includes diabetics with periodontal disease; they will receive standard therapy, scaling & root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks. Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops. Scaling & Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums. Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline | Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured | Posted | Mean | Standard Deviation | mm | Baseline to 6 months |
|
6 Months After Treatment at Baseline
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diabetic + SRP + SPT | The group includes diabetics with periodontal disease; they will receive standard therapy, scaling & root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks. Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops. Scaling & Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums. Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lu Li | University at Buffalo | 7168296284 | lli59@buffalo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2022 | Aug 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D009063 |
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|
|
| Scaling & Root Planing | Procedure | SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums. |
|
|
| Soft Picks | Device | Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores. |
|
The distance from the Cemento-enamel Junction (CEJ) to the free gingival margin is measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive. |
| Baseline to 3 months;Baseline to 6 months |
| Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline | The analysis is based on the measures of each participant. Participant instead of site is used as unite for arm/group. The measure, % sites with probing pocket depth >= 4 mm within each participant, indicates the portion of deep pocket in a participant. Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; The percentage of sites with Periodontal PD >= 4 mm within each participant was compared between measured time points. | Baseline to 3 months; Baseline to 6 months |
| Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline | The analysis is based on the measures of each participant. 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing per participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index per participant is compared between time points measured. | Baseline to 3 months; Baseline to 6 months |
| Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline | The analysis is based on the measures of each participant. Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth are evaluated. The Plaque Index (PI) of each participant is defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. The PI of each participant is assessed and compared between measured time points. | Baseline to 3 months; Baseline to 6 months |
| Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics | Probing depth (PD) or probing pocket depth (PPD), measured on six surfaces/tooth, is the distance in millimeters (mm) from the gingival margin to the base of the gingival pocket | Baseline to 3 months; Baseline to 6 months |
| Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | The distance from the Cemento-enamel Junction (CEJ) to the free gingival margin is measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive. | Baseline to 3 months; Baseline to 6 months |
| Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics | The analysis is based on the measure of each participant. Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; The percentage of sites with Periodontal PD >= 4 mm per participant is compared between measured time points. | Baseline to 3 months; Baseline to 6 months |
| Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | The analysis is based on the measures of each participant. 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing per participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index per participant is compared between time points measured. | Baseline to 3 months; Baseline to 6 months |
| Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | The analysis is based on the measures of each participant. Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth are evaluated. The Plaque Index (PI) of each participant is defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. The PI of each participant is assessed and compared between measured time points. | Baseline to 3 months; Baseline to 6 months |
| Changes in Hemoglobin A1c at 6 Months After Treatment | Hemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes. | Baseline to 6 months |
| Changes in Fasting Blood Glucose at 6 Months After Treatment | Fasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes. | Baseline to 6 months |
| Change in High Sensitivity C-reactive Protein at 6 Months After Treatment | The high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause | Baseline to 6 months |
| Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics | Hemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes. | Baseline to 6 months |
| Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics | Fasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes. | Baseline to 6 months |
| Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics | The high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause | Baseline to 6 months |
| Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months | Shannon index represents mean species diversity in a site at a local scale. Shannon index quantifies the uncertainty in predicting the species identity of an individual that is taken at random from the dataset. The minimum value is 0 and there is no maximum value. High values mean high species diversities. | Baseline; 6 Months |
| Change in Distance to the Healthy Plane Based on the Subgingival Plaque Microbiome at 6 Months | Analysis of microbiome community changes using the healthy plane (HP) as a reference. A healthy plane was calculated by fitting a plane that minimizes the sum of squares of distances from HC samples to the nearest point on the plane. The distance of each sample to the HP was then calculated. Higher values of distance to HP mean microbiome community changes towards disease status | Baseline to 6 Months |
| 24708451 | Background | Arora N, Papapanou PN, Rosenbaum M, Jacobs DR Jr, Desvarieux M, Demmer RT. Periodontal infection, impaired fasting glucose and impaired glucose tolerance: results from the Continuous National Health and Nutrition Examination Survey 2009-2010. J Clin Periodontol. 2014 Jul;41(7):643-52. doi: 10.1111/jcpe.12258. Epub 2014 May 25. |
| 23631575 | Background | Engebretson S, Kocher T. Evidence that periodontal treatment improves diabetes outcomes: a systematic review and meta-analysis. J Periodontol. 2013 Apr;84(4 Suppl):S153-69. doi: 10.1902/jop.2013.1340017. |
| 23106512 | Background | Sgolastra F, Severino M, Pietropaoli D, Gatto R, Monaco A. Effectiveness of periodontal treatment to improve metabolic control in patients with chronic periodontitis and type 2 diabetes: a meta-analysis of randomized clinical trials. J Periodontol. 2013 Jul;84(7):958-73. doi: 10.1902/jop.2012.120377. Epub 2012 Oct 29. |
| 24346989 | Background | Engebretson SP, Hyman LG, Michalowicz BS, Schoenfeld ER, Gelato MC, Hou W, Seaquist ER, Reddy MS, Lewis CE, Oates TW, Tripathy D, Katancik JA, Orlander PR, Paquette DW, Hanson NQ, Tsai MY. The effect of nonsurgical periodontal therapy on hemoglobin A1c levels in persons with type 2 diabetes and chronic periodontitis: a randomized clinical trial. JAMA. 2013 Dec 18;310(23):2523-32. doi: 10.1001/jama.2013.282431. |
| 25234213 | Background | Borgnakke WS, Chapple IL, Genco RJ, Armitage G, Bartold PM, D'Aiuto F, Eke PI, Giannobile WV, Kocher T, Kornman KS, Lang NP, Madianos PN, Murakami S, Nishimura F, Offenbacher S, Preshaw PM, Rahman AU, Sanz M, Slots J, Tonetti MS, Van Dyke TE. The multi-center randomized controlled trial (RCT) published by the journal of the American Medical Association (JAMA) on the effect of periodontal therapy on glycated hemoglobin (HbA1c) has fundamental problems. J Evid Based Dent Pract. 2014 Sep;14(3):127-32. doi: 10.1016/j.jebdp.2014.04.017. Epub 2014 May 21. |
| 19722792 | Background | Colombo AP, Boches SK, Cotton SL, Goodson JM, Kent R, Haffajee AD, Socransky SS, Hasturk H, Van Dyke TE, Dewhirst F, Paster BJ. Comparisons of subgingival microbial profiles of refractory periodontitis, severe periodontitis, and periodontal health using the human oral microbe identification microarray. J Periodontol. 2009 Sep;80(9):1421-32. doi: 10.1902/jop.2009.090185. |
| 22324467 | Background | Colombo AP, Bennet S, Cotton SL, Goodson JM, Kent R, Haffajee AD, Socransky SS, Hasturk H, Van Dyke TE, Dewhirst FE, Paster BJ. Impact of periodontal therapy on the subgingival microbiota of severe periodontitis: comparison between good responders and individuals with refractory periodontitis using the human oral microbe identification microarray. J Periodontol. 2012 Oct;83(10):1279-87. doi: 10.1902/jop.2012.110566. Epub 2012 Feb 10. |
| 25398868 | Background | Kirst ME, Li EC, Alfant B, Chi YY, Walker C, Magnusson I, Wang GP. Dysbiosis and alterations in predicted functions of the subgingival microbiome in chronic periodontitis. Appl Environ Microbiol. 2015 Jan;81(2):783-93. doi: 10.1128/AEM.02712-14. Epub 2014 Nov 14. |
| 23673380 | Background | Wang J, Qi J, Zhao H, He S, Zhang Y, Wei S, Zhao F. Metagenomic sequencing reveals microbiota and its functional potential associated with periodontal disease. Sci Rep. 2013;3:1843. doi: 10.1038/srep01843. |
| 25074492 | Background | Perez-Chaparro PJ, Goncalves C, Figueiredo LC, Faveri M, Lobao E, Tamashiro N, Duarte P, Feres M. Newly identified pathogens associated with periodontitis: a systematic review. J Dent Res. 2014 Sep;93(9):846-58. doi: 10.1177/0022034514542468. Epub 2014 Jul 29. |
| 1524682 | Background | Beiswanger BB, Mallat ME, Jackson RD, Mau MS, Farah CF, Bosma ML, Bollmer BW, Hancock EB. Clinical effects of a 0.12% chlorhexidine rinse as an adjunct to scaling and root planing. J Clin Dent. 1992;3(2):33-8. |
| 16965522 | Background | Faveri M, Gursky LC, Feres M, Shibli JA, Salvador SL, de Figueiredo LC. Scaling and root planing and chlorhexidine mouthrinses in the treatment of chronic periodontitis: a randomized, placebo-controlled clinical trial. J Clin Periodontol. 2006 Nov;33(11):819-28. doi: 10.1111/j.1600-051X.2006.00994.x. Epub 2006 Sep 11. |
| 24407549 | Background | Abouassi T, Woelber JP, Holst K, Stampf S, Doerfer CE, Hellwig E, Ratka-Kruger P. Clinical efficacy and patients' acceptance of a rubber interdental bristle. A randomized controlled trial. Clin Oral Investig. 2014 Sep;18(7):1873-80. doi: 10.1007/s00784-013-1164-3. Epub 2014 Jan 10. |
| 23305133 | Background | Santos VR, Lima JA, Miranda TS, Goncalves TE, Figueiredo LC, Faveri M, Duarte PM. Full-mouth disinfection as a therapeutic protocol for type-2 diabetic subjects with chronic periodontitis: twelve-month clinical outcomes: a randomized controlled clinical trial. J Clin Periodontol. 2013 Feb;40(2):155-62. doi: 10.1111/jcpe.12040. |
| 37148266 | Derived | Li L, Hayashi-Okada Y, Falkner KL, Cervi S, Andrusz S, Shimizu Y, Zambon JJ, Kirkwood KL, Schifferle RE, Diaz PI. Randomized Trial to Test a Chemo-Mechanical Antiplaque Regimen as Adjunct to Periodontal Therapy. JDR Clin Trans Res. 2024 Apr;9(2):160-169. doi: 10.1177/23800844231167065. Epub 2023 May 6. |
| Lost to Follow-up |
|
| BG001 | Diabetic + SRP | The group includes diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP). Scaling & Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums. |
| BG002 | Non-Diabetic + SRP + SPT | The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling & root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks. Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops. Scaling & Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums. Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores. |
| BG003 | Non-Diabetic + SRP | The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP). Scaling & Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education | Mean | Standard Deviation | year |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Smoking History | Count of Participants | Participants |
|
| Alcohol Intake | Count of Participants | Participants |
|
| Whole Mouth Mean Pocket Depth | Mean | Standard Deviation | mm |
|
| Whole Mouth Mean Clinical Attachment Loss | The clinical attachment loss level is defined as the distance from the Cemento-enamel Junction (CEJ) to the free gingival margin, measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive. | Mean | Standard Deviation | mm |
|
| % sites with Pocket Depth ≥ 4 mm per participant | Unit participant instead of site is assigned to arm/group in this measure. Periodontal PD in millimeters was measured with a UNC-15 periodontal probe on 6 sites per tooth. The percentage of sites with Periodontal PD >= 4 mm per participant is accessed, which represents the portion of deep pocket of the participant, indicating the clinical severity. | Mean | Standard Deviation | % sites with PD >= 4 mm of a participant |
|
| Bleeding on Probing (BOP) Index per participant | Unit participant instead of site is assigned to arm/group in this measure. 0 is the absence of gingival bleeding, and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing in a participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index of each participant is accessed and compared between groups. | Mean | Standard Deviation | BOP index of a participant |
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| Plaque Index (PI) per participant | Unit participant instead of site is assigned to arm/group in this measure. Plaque was visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth were evaluated. The Plaque Index (PI) of each participant was defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. And the PI of each participant were analyzed and compared between groups. | Mean | Standard Deviation | Plaque Index of a participant |
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| Hemoglobin A1c | Median | Inter-Quartile Range | % of hemoglobin a1c |
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| Fasting Blood Glucose | Median | Inter-Quartile Range | mg/dL |
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| C-reactive Protein (CRP) | Median | Inter-Quartile Range | mg/L |
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| OG001 | Group B: SRP | The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP). Scaling & Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums. |
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| Secondary | Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline | Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured | Posted | Mean | Standard Deviation | mm | Baseline to 3 months |
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| Secondary | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline | The distance from the Cemento-enamel Junction (CEJ) to the free gingival margin is measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive. | Posted | Mean | Standard Deviation | mm | Baseline to 3 months;Baseline to 6 months |
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| Secondary | Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline | The analysis is based on the measures of each participant. Participant instead of site is used as unite for arm/group. The measure, % sites with probing pocket depth >= 4 mm within each participant, indicates the portion of deep pocket in a participant. Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; The percentage of sites with Periodontal PD >= 4 mm within each participant was compared between measured time points. | For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants. | Posted | Mean | Standard Deviation | % sites with PD >= 4 mm of a participant | Baseline to 3 months; Baseline to 6 months |
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| Secondary | Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline | The analysis is based on the measures of each participant. 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing per participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index per participant is compared between time points measured. | For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants. | Posted | Mean | Standard Deviation | BOP index of a participant | Baseline to 3 months; Baseline to 6 months |
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| Secondary | Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline | The analysis is based on the measures of each participant. Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth are evaluated. The Plaque Index (PI) of each participant is defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. The PI of each participant is assessed and compared between measured time points. | For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants. | Posted | Mean | Standard Deviation | Plaque Index of a participant | Baseline to 3 months; Baseline to 6 months |
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| Secondary | Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics | Probing depth (PD) or probing pocket depth (PPD), measured on six surfaces/tooth, is the distance in millimeters (mm) from the gingival margin to the base of the gingival pocket | Posted | Mean | Standard Deviation | mm | Baseline to 3 months; Baseline to 6 months |
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| Secondary | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | The distance from the Cemento-enamel Junction (CEJ) to the free gingival margin is measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive. | Posted | Mean | Standard Deviation | mm | Baseline to 3 months; Baseline to 6 months |
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| Secondary | Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics | The analysis is based on the measure of each participant. Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; The percentage of sites with Periodontal PD >= 4 mm per participant is compared between measured time points. | For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants. | Posted | Mean | Standard Deviation | % sites with PD >= 4 mm of a participant | Baseline to 3 months; Baseline to 6 months |
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| Secondary | Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | The analysis is based on the measures of each participant. 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing per participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index per participant is compared between time points measured. | For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants. | Posted | Mean | Standard Deviation | BOP index of a participant | Baseline to 3 months; Baseline to 6 months |
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| Secondary | Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | The analysis is based on the measures of each participant. Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth are evaluated. The Plaque Index (PI) of each participant is defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. The PI of each participant is assessed and compared between measured time points. | For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants. | Posted | Mean | Standard Deviation | Plaque Index of a participant | Baseline to 3 months; Baseline to 6 months |
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| Secondary | Changes in Hemoglobin A1c at 6 Months After Treatment | Hemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes. | Posted | Mean | Standard Deviation | % of hemoglobin a1c | Baseline to 6 months |
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| Secondary | Changes in Fasting Blood Glucose at 6 Months After Treatment | Fasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes. | Posted | Mean | Standard Deviation | mg/dL | Baseline to 6 months |
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| Secondary | Change in High Sensitivity C-reactive Protein at 6 Months After Treatment | The high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause | Posted | Mean | Standard Deviation | mg/L | Baseline to 6 months |
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| Secondary | Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics | Hemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes. | Posted | Mean | Standard Deviation | % of hemoglobin a1c | Baseline to 6 months |
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| Secondary | Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics | Fasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes. | Posted | Mean | Standard Deviation | mg/dL | Baseline to 6 months |
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| Secondary | Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics | The high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause | Posted | Mean | Standard Deviation | mg/L | Baseline to 6 months |
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| Secondary | Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months | Shannon index represents mean species diversity in a site at a local scale. Shannon index quantifies the uncertainty in predicting the species identity of an individual that is taken at random from the dataset. The minimum value is 0 and there is no maximum value. High values mean high species diversities. | Posted | Mean | Standard Deviation | Shannon index value | Baseline; 6 Months |
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| Secondary | Change in Distance to the Healthy Plane Based on the Subgingival Plaque Microbiome at 6 Months | Analysis of microbiome community changes using the healthy plane (HP) as a reference. A healthy plane was calculated by fitting a plane that minimizes the sum of squares of distances from HC samples to the nearest point on the plane. The distance of each sample to the HP was then calculated. Higher values of distance to HP mean microbiome community changes towards disease status | Posted | Mean | Standard Deviation | distance to the healthy plane | Baseline to 6 Months |
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Diabetic + SRP | The group includes diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP). Scaling & Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG002 | Non-Diabetic + SRP + SPT | The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling & root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks. Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops. Scaling & Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums. Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG003 | Non-Diabetic + SRP | The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP). Scaling & Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums. | 0 | 18 | 0 | 18 | 0 | 18 |
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |
used generalized linear models adjusted for baseline CRP |
| 0.8 |
| Superiority |
used generalized linear models adjusted for baseline CRP
| 0.09 |
| Superiority |
used generalized linear models adjusted for baseline CRP |
| 0.03 |
| Superiority |
used generalized linear models adjusted for baseline CRP |
| 0.09 |
| Superiority |
| Baseline to 6-month |
|
used generalized linear models adjusted for baseline CRP
| 0.86 |
| Superiority |
| Baseline to 6 months | t-test, 2 sided | 0.047 | Superiority |
| Baseline to 6 months | t-test, 2 sided | used generalized linear models adjusted for baseline CRP | 0.75 | Superiority |
| Baseline to 6 months |
|
used generalized linear models adjusted for baseline CRP
| 0.22 |
| Superiority |
| Baseline to 6 months | t-test, 2 sided | 0.29 | Superiority |
| Baseline to 6 months | t-test, 2 sided | used generalized linear models adjusted for baseline CRP | 0.15 | Superiority |
| Baseline to 6-month |
|
used generalized linear models adjusted for baseline CRP
| 0.31 |
| Superiority |
| Baseline to 6 months | t-test, 2 sided | 0.08 | Superiority |
| Baseline to 6 months | t-test, 2 sided | used generalized linear models adjusted for baseline CRP | 0.54 | Superiority |
| Baseline to 6 months |
|
used generalized linear models adjusted for baseline CRP
| 0.04 |
| Superiority |
| Baseline to 6 months | t-test, 2 sided | 0.03 | Superiority |
| Baseline to 6 months | t-test, 2 sided | used generalized linear models adjusted for baseline CRP | 0.38 | Superiority |
| Baseline to 6 months |
|
used generalized linear models adjusted for baseline CRP
| 0.18 |
| Superiority |
| Baseline to 6 months | t-test, 2 sided | 0.08 | Superiority |
| Baseline to 6 months | t-test, 2 sided | used generalized linear models adjusted for baseline CRP | 0.41 | Superiority |
| Superiority |
| Superiority |
| Superiority |
| 0.29 |
| Superiority |