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| ID | Type | Description | Link |
|---|---|---|---|
| CRO-2020-03-VERILY-LK | Other Identifier | Verily |
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| Name | Class |
|---|---|
| Colgate Palmolive | INDUSTRY |
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Purpose: The Baseline Oral Health Health Study is a randomized controlled trial to evaluate the impact of regular, professional non-surgical Intensive Periodontal Therapy (scaling and root planing and optimal oral hygiene with associated professional oral health behavior advice ), on oral health as well as whether such effects are associated with corresponding changes to biomarkers characterizing systemic health.
Participants: The Baseline Oral Health Study will enroll approximately 200 participants in the study with approximately 100 participants each within the Control Group and the Treatment Group. The study population will be recruited from the Project Baseline Health Study participants in the North Carolina region and may be expanded to include subjects recruited from University of North Carolina (UNC) if the initial screening from Project Baseline Health Study pool of participants in the North Carolina region does not fulfill study enrollment powering.
Procedures (methods): The study population will be recruited from Project Baseline Health Study participants. The Project Baseline Health Study is a longitudinal cohort study which characterizes participants across clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, or other health-related measurements from onsite and/or remote visits, continuous monitoring through sensor technology, and regular engagement via an online portal, and mobile app. The study population will be recruited from Project Baseline Health Study participants diagnosed with cardiovascular disease and/or type 2 diabetes mellitus (including prediabetes) and eligible for periodontal intervention. The study will use dental centers and an experienced dental team to manage the oral care provided in this study.
The Baseline Oral Health Health Study is a randomized controlled trial to evaluate the impact of regular, professional non-surgical Intensive Periodontal Therapy (scaling and root planing and optimal oral hygiene with associated professional oral health behavior advice ), on oral health as well as whether such effects are associated with corresponding changes to biomarkers characterizing systemic health. The study will be conducted in partnership with Verily and the Project Baseline Team, Colgate, and the University of North Carolina. The study population will be recruited from Project Baseline Health Study participants. The Project Baseline Health Study is a longitudinal cohort study which characterizes participants across clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, or other health-related measurements from onsite and/or remote visits, continuous monitoring through sensor technology, and regular engagement via an online portal, and mobile app.
The study population will be recruited from Project Baseline Health Study participants diagnosed with cardiovascular disease and/or type 2 diabetes mellitus (including prediabetes) and eligible for periodontal intervention. The study will use dental centers and an experienced dental team to manage the oral care provided in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS & PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement. |
|
| Control Group | Active Comparator | The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling & root planning (SRP). Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subgingival chlorhexidine irrigation | Drug | The dose information for the Chlorhexidine gluconate will be 0.12% with 1 mL in each dental pocket at a frequency of every 3 months for the duration of the study (18 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Treatment on Change in Oral Health Measures | The impact of treatment on oral health measures, will be performed using generalized estimating equations (GEE) methods. Longitudinal outcomes in the Treated vs. Control groups will be compared and will include all subjects who were randomized and their data from visits T1 - T4 based on intent-to-treat (ITT) group assignment. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. | Comparing T1 (day 90) and T4 (day 360) |
| Association Between Changes in Oral Health (Probing Depth) and Changes in Systemic Health (HbA1c) | The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. The correlation between % change in whole-mouth mean probing depth and % change in HbA1c will be determined in subjects with prediabetes or type 2 diabetes at screening. | Comparing T0 (day 0) and T4 (day 360) |
| Association Between Changes in Oral Health and Changes in Systemic Health (Flow-mediated Dilation) | The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. The correlation between % change in whole-mouth mean probing depth and change in flow-mediated dilation will be calculated. | Comparing T0 (day 0) and T4 (day 360) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Emotional Wellbeing | Emotional wellbeing will be evaluated through the use of PANAS (Positive Affect and Negative Affect Scales). PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure is change in the 10 item positive affect subscale. |
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Inclusion Criteria:
At least eighteen (18) years of age but not older than seventy (70) years of age at the time of screening
Able to speak and read English
Has at least 16 teeth present.
Able to consent, follow an outpatient protocol, and is available by telephone
Has either moderate (stage II) or severe (stage III) periodontitis:
Has at least one of the following indicators of cardiometabolic disease in the following range:
Type 2 diabetes: 9% ≥ HbA1c ≥ 6.5% OR Prediabetes: 6.4%≥ HbA1c ≥ 5.7% OR
Cardiovascular Disease (CVD):
Access to Apple (iOS) devices or Android devices with appropriate versions to be compatible with the applications to complete study procedures.
Females of childbearing capacity must be willing to have pregnancy test
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saroja Voruganti, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States | ||
| UNC Nutrition Research Institute |
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
9 to 36 months following publication
The investigator who proposes to use the data has approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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Of the 786 participants who signed informed consent, 194 completed the required assessments, and remained eligible. Of the 194 eligible participants, 39 declined to be randomized. Of the 155 randomized participants, two did not continue following randomization and did not receive any exposure to a study intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling & root planning (SRP). Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit. Periodontal Treatment: Initial periodontal treatment consisting of a pre-procedural rinse and scaling & root planing (SRP). |
| FG001 | Treatment Group | The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS & PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement. Subgingival chlorhexidine irrigation: The dose information for the Chlorhexidine gluconate will be 0.12% with 1 mL in each dental pocket at a frequency of every 3 months for the duration of the study (18 months). Dental Supplies: Subjects in the Treatment Group will receive a commercial electric toothbrush (Colgate hum), toothpaste (Colgate Renewal), mouthwash (Colgate Zero), proxabrush (Colgate), and floss (Colgate Palmolive brand) to be used at home along with instructions on their use. Brush heads for the electric toothbrush will be replaced every 3 months and products (toothpaste, mouthwash, proxabrush, and floss) will be replenished at every site visit. Periodonal Treatment: Initial periodontal treatment consisting of a pre-procedural rinse and scaling & root planing (SRP). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
two participants withdrew between randomization and first intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling & root planning (SRP). Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit. Periodonal Treatment: Initial periodontal treatment consisting of a pre-procedural rinse and scaling & root planing (SRP). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Impact of Treatment on Change in Oral Health Measures | The impact of treatment on oral health measures, will be performed using generalized estimating equations (GEE) methods. Longitudinal outcomes in the Treated vs. Control groups will be compared and will include all subjects who were randomized and their data from visits T1 - T4 based on intent-to-treat (ITT) group assignment. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. | Data include imputation. Predictions based on linear mixed models were used for imputation. | Posted | Least Squares Mean | 95% Confidence Interval | millimeters (probing depth difference) | Comparing T1 (day 90) and T4 (day 360) |
|
From T0 (day 0) through the end of study, up to 15 months
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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 | Control Group | The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling & root planning (SRP). Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment | participant was a no-show for several scheduled visits and later reported hospitalization for pancreatitis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Saroja Voruganti, PhD | University of North Carolina at Chapel Hill | 704 250-5009 | saroja@unc.edu |
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| 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 | May 2, 2023 | Dec 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The investigator and all sub-investigators will make every effort to remain blinded as to the subject regimen. Periodontal treatment throughout the Study will be provided only by experienced general dentists, periodontists or dental hygienists who are licensed, trained and calibrated prior to the start of the study. In order to maintain examiner blinding throughout the study, the treatment provider will be a person other than the dental examiner and will exclusively provide treatment and not participate in patient assessments.
| Dental Supplies | Other | Subjects in the Treatment Group will receive a commercial electric toothbrush (Colgate hum), toothpaste (Colgate Renewal), mouthwash (Colgate Zero), proxabrush (Colgate), and floss (Colgate Palmolive brand) to be used at home along with instructions on their use. Brush heads for the electric toothbrush will be replaced every 3 months and products (toothpaste, mouthwash, proxabrush, and floss) will be replenished at every site visit. |
|
| Periodonal Treatment | Other | Initial periodontal treatment consisting of a pre-procedural rinse and scaling & root planing (SRP). |
|
| Comparing T0 (day 0) and T4 (day 360) |
| Change in Beliefs About Periodontal Disease | Beliefs about periodontal disease will be evaluated through the use of a Protective Motivation Theory (PMT) survey. PMT surveys assess an individual's motivation to adopt protective health behaviors by focusing on specific cognitive processes. This survey includes 7 statements related to opinions on periodontal disease and treatment (e.g., "Periodontal disease worries me," "Adhering to my periodontal treatment instructions over the next weeks will improve my oral health"). Each survey item is scored from 1 to 10 with 1 being "not at all" to 10 being "extremely so." Higher values indicate stronger agreement with the survey statements. Reported outcome measures represent total survey scores (range from 7 to 70). | Comparing T0 (day 0) and T4 (day 360) |
| Change in Bleeding on Probing | Whole-mouth mean of tooth-specific dichotomic response (bleeding = 1, no bleeding = 0) after probing the gingival sulcus. | Comparing T0 (day 0) and T4 (day 360) |
| Change in Gingival Index | The gingival index will be scored on three facial surfaces (distofacial, facial, mesiofacial) and three lingual surfaces (distolingual, lingual, mesiolingual). Areas are examined by placing the periodontal probe under the gingival margin at approximately 1mm deep and sweeping the probe from the distal surface to the mesial surface in quadrants I and IV and mesial to the distal surface in quadrants II and III. After each quadrant is swept, calls are made based on gingival inflammation and the presence or absence of bleeding according to criteria which range from 0 to 3. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation. For this Outcome Measure, less inflammation (lower number) correlates with better outcome. Reported outcome measure is whole-mouth mean value (six surfaces of each tooth), with a range of 0 to 3. | Comparing T0 (day 0) and T4 (day 360) |
| Percent Change in Clinical Attachment Level (CAL) | Percent change of whole-mouth mean clinical attachment level (CAL, defined as measured pocket depth - gingival margin, for each site). Percent change calculated as (CAL@T4 - CAL@T0)/CAL@T0. | Comparing T0 (day 0) and T4 (day 360) |
| Change in Dental Plaque Index | Change of digitally measured interdental plaque area. Full mouth plaque assessment shall be assessed using the UNC Modified Plaque Index (Greene and Vermillion). Plaque scores shall be visually assessed at 6 sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual surfaces) on a scale of 0-3. Scores are the following: 0 =No debris or stain present on the clinical crown; 1 =Soft debris covering not more than 1/3 of the clinical crown (cervical 3rd), or presence of extrinsic stains without other debris regardless of surface area covered; 2 =Soft debris covering more than 1/3, but not more than 2/3 (middle 3rd) of the clinical crown; 3 =Soft debris covering more than 2/3 of the clinical crown. Reported outcome measure is calculated as whole-mouth mean (mean of each site at each tooth) with a range of 0 to 3. | Comparing T0 (day 0) and T4 (day 360) |
| Change in Flow-mediated Dilation | Change of flow mediated dilation. Ultrasound images of the right brachial artery and Doppler measures of arterial flow will be acquired before and after reactive hyperemia is induced by inflating a pneumatic occlusion cuff placed around the lower arm. FMD will be calculated as the percent change in arterial diameter from baseline. | Comparing T0 (day 0) and T4 (day 360) |
| Percent Change in Glycated Hemoglobin (HbA1c) (Prediabetic and Type 2 Diabetic Cohorts) | Percent change of HbA1c (% glycated) from day 0 to day 360 [(HbA1c@T4 - HbA1c@T0) / HbA1c@T0] in the prediabetic and diabetic cohorts (HbA1c >= 5.7 at screening) | Comparing T0 (day 0) and T4 (day 360) |
| Percent Change in Carotid Intima Media Thickness (IMT) | Percent change of IMT. Longitudinal ultrasound images of the distal 1 cm segments of the right and left common carotid arteries, carotid bulbs, and internal carotid arteries will be acquired. IMT will be measured as the distance between luminal-intimal interface and medial-adventitial interface. Mean IMT will be calculated as the average of all measurements; mean maximum IMT will be calculated as the average of maximum wall thicknesses for each of the regions. Percent change of IMT (mm) from day 0 to day 360 is calculated as (IMT@T4 - IMT@T0) / IMT@T0] | Comparing T0 (day 0) and T4 (day 360) |
| Percent Change of High Sensitivity C-reactive Protein (Hs-CRP) | Percent change of hs-CRP (mg/dL) from day 0 to day 360 [(CRP@T4 - CRP@T0) / CRP@T0] | Comparing T0 (day 0) and T4 (day 360) |
| Percent Change in Total Cholesterol | Percent change of total cholesterol (mg/dL) from day 0 to day 360 [(tchol@T4 - tchol@T0) / tchol@T0] | Comparing T0 (day 0) and T4 (day 360) |
| Percent Change in Low Density Lipoprotein (LDL) Cholesterol | Percent change of low density lipoproteins (LDL) cholesterol (mg/dL) from day 0 to day 360 [(LDL@T4 - LDL@T0) / LDL@T0] | Comparing T0 (day 0) and T4 (day 360) |
| Percent Change in Triglycerides | Percent change of triglycerides (mg/dL) from day 0 to day 360 [(trig@T4 - trig@T0) / trig@T0] | Comparing T0 (day 0) and T4 (day 360) |
| Kannapolis |
| North Carolina |
| 28081 |
| United States |
| Withdrawal by Subject |
|
| Physician Decision |
|
| Death |
|
| Adverse Event |
|
| BG001 | Treatment Group | The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS & PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement. Subgingival chlorhexidine irrigation: The dose information for the Chlorhexidine gluconate will be 0.12% with 1 mL in each dental pocket at a frequency of every 3 months for the duration of the study (18 months). Dental Supplies: Subjects in the Treatment Group will receive a commercial electric toothbrush (Colgate hum), toothpaste (Colgate Renewal), mouthwash (Colgate Zero), proxabrush (Colgate), and floss (Colgate Palmolive brand) to be used at home along with instructions on their use. Brush heads for the electric toothbrush will be replaced every 3 months and products (toothpaste, mouthwash, proxabrush, and floss) will be replenished at every site visit. Periodonal Treatment: Initial periodontal treatment consisting of a pre-procedural rinse and scaling & root planing (SRP). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Diabetes/pre-diabetes | Prediabetes/diabetes defined as HbA1c at screening >=5.7 | HbA1c was measured at screening for classification. For one participant, HbA1c at screening was not recorded and classification was based on HbA1c measured at T0 (day 0). For two participants, HbA1c was not recorded at screening not recorded at T0, and no prediabetes/diabetes classification was made. | Count of Participants | Participants |
|
| OG001 | Treatment Group | The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS & PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement. |
|
|
|
| Primary | Association Between Changes in Oral Health (Probing Depth) and Changes in Systemic Health (HbA1c) | The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. The correlation between % change in whole-mouth mean probing depth and % change in HbA1c will be determined in subjects with prediabetes or type 2 diabetes at screening. | Analysis population includes only participants meeting the following criteria: (1) HbA1c data was available at T0 and T4 time points, (2) probing depth data was available at T0 and T4 time points, and (3) screening HbA1c >= 5.7 (if screening value was not available, T0 value of HbA1c >= 5.7 was used as proxy). | Posted | Number | Pearson correlation coefficient | Comparing T0 (day 0) and T4 (day 360) |
|
|
|
|
| Primary | Association Between Changes in Oral Health and Changes in Systemic Health (Flow-mediated Dilation) | The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. The correlation between % change in whole-mouth mean probing depth and change in flow-mediated dilation will be calculated. | Analysis population includes only participants meeting the following criteria: (1) flow mediated dilation data was available at T0 and T4 time points, (2) probing depth data was available at T0 and T4 time points. | Posted | Number | Pearson correlation coefficient | Comparing T0 (day 0) and T4 (day 360) |
|
|
|
|
| Secondary | Change in Emotional Wellbeing | Emotional wellbeing will be evaluated through the use of PANAS (Positive Affect and Negative Affect Scales). PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure is change in the 10 item positive affect subscale. | Analysis population includes only participants who completed the survey at T0 and T4 time points. | Posted | Mean | Standard Deviation | scores on a scale | Comparing T0 (day 0) and T4 (day 360) |
|
|
|
|
| Secondary | Change in Beliefs About Periodontal Disease | Beliefs about periodontal disease will be evaluated through the use of a Protective Motivation Theory (PMT) survey. PMT surveys assess an individual's motivation to adopt protective health behaviors by focusing on specific cognitive processes. This survey includes 7 statements related to opinions on periodontal disease and treatment (e.g., "Periodontal disease worries me," "Adhering to my periodontal treatment instructions over the next weeks will improve my oral health"). Each survey item is scored from 1 to 10 with 1 being "not at all" to 10 being "extremely so." Higher values indicate stronger agreement with the survey statements. Reported outcome measures represent total survey scores (range from 7 to 70). | Analysis population includes only participants who completed the survey at T0 and T4 time points. | Posted | Mean | Standard Deviation | scores on a scale | Comparing T0 (day 0) and T4 (day 360) |
|
|
|
|
| Secondary | Change in Bleeding on Probing | Whole-mouth mean of tooth-specific dichotomic response (bleeding = 1, no bleeding = 0) after probing the gingival sulcus. | Analysis population includes only participants who received dental assessment at T0 and T4 time points. | Posted | Mean | Standard Deviation | scores on a scale | Comparing T0 (day 0) and T4 (day 360) |
|
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|
|
| Secondary | Change in Gingival Index | The gingival index will be scored on three facial surfaces (distofacial, facial, mesiofacial) and three lingual surfaces (distolingual, lingual, mesiolingual). Areas are examined by placing the periodontal probe under the gingival margin at approximately 1mm deep and sweeping the probe from the distal surface to the mesial surface in quadrants I and IV and mesial to the distal surface in quadrants II and III. After each quadrant is swept, calls are made based on gingival inflammation and the presence or absence of bleeding according to criteria which range from 0 to 3. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation. For this Outcome Measure, less inflammation (lower number) correlates with better outcome. Reported outcome measure is whole-mouth mean value (six surfaces of each tooth), with a range of 0 to 3. | Analysis population includes only participants who received dental assessment at T0 and T4 time points. | Posted | Mean | Standard Deviation | scores on a scale | Comparing T0 (day 0) and T4 (day 360) |
|
|
|
|
| Secondary | Percent Change in Clinical Attachment Level (CAL) | Percent change of whole-mouth mean clinical attachment level (CAL, defined as measured pocket depth - gingival margin, for each site). Percent change calculated as (CAL@T4 - CAL@T0)/CAL@T0. | Analysis population includes only participants who received dental assessment at T0 and T4 time points. | Posted | Mean | Standard Deviation | % change | Comparing T0 (day 0) and T4 (day 360) |
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| Secondary | Change in Dental Plaque Index | Change of digitally measured interdental plaque area. Full mouth plaque assessment shall be assessed using the UNC Modified Plaque Index (Greene and Vermillion). Plaque scores shall be visually assessed at 6 sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual surfaces) on a scale of 0-3. Scores are the following: 0 =No debris or stain present on the clinical crown; 1 =Soft debris covering not more than 1/3 of the clinical crown (cervical 3rd), or presence of extrinsic stains without other debris regardless of surface area covered; 2 =Soft debris covering more than 1/3, but not more than 2/3 (middle 3rd) of the clinical crown; 3 =Soft debris covering more than 2/3 of the clinical crown. Reported outcome measure is calculated as whole-mouth mean (mean of each site at each tooth) with a range of 0 to 3. | Analysis population includes only participants who received dental assessment at T0 and T4 time points. | Posted | Mean | Standard Deviation | scores on a scale | Comparing T0 (day 0) and T4 (day 360) |
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| Secondary | Change in Flow-mediated Dilation | Change of flow mediated dilation. Ultrasound images of the right brachial artery and Doppler measures of arterial flow will be acquired before and after reactive hyperemia is induced by inflating a pneumatic occlusion cuff placed around the lower arm. FMD will be calculated as the percent change in arterial diameter from baseline. | Some participants did not have FMD measured at T0 and/or T4 and are not included in the T4-T0 comparison. Missing data arises from a combination of participant withdrawal/loss to followup and poor ultrasound data quality. | Posted | Mean | Standard Deviation | % change | Comparing T0 (day 0) and T4 (day 360) |
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| Secondary | Percent Change in Glycated Hemoglobin (HbA1c) (Prediabetic and Type 2 Diabetic Cohorts) | Percent change of HbA1c (% glycated) from day 0 to day 360 [(HbA1c@T4 - HbA1c@T0) / HbA1c@T0] in the prediabetic and diabetic cohorts (HbA1c >= 5.7 at screening) | Analysis population includes only participants meeting the following criteria: (1) biomarker data was available at T0 and T4 time points and (2) screening HbA1c >= 5.7 (if screening value was not available, T0 value of HbA1c >= 5.7 was used as proxy). | Posted | Mean | Standard Deviation | % change | Comparing T0 (day 0) and T4 (day 360) |
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| Secondary | Percent Change in Carotid Intima Media Thickness (IMT) | Percent change of IMT. Longitudinal ultrasound images of the distal 1 cm segments of the right and left common carotid arteries, carotid bulbs, and internal carotid arteries will be acquired. IMT will be measured as the distance between luminal-intimal interface and medial-adventitial interface. Mean IMT will be calculated as the average of all measurements; mean maximum IMT will be calculated as the average of maximum wall thicknesses for each of the regions. Percent change of IMT (mm) from day 0 to day 360 is calculated as (IMT@T4 - IMT@T0) / IMT@T0] | Some participants are missing measurement data at either T0 or T4 timepoints, precluding calculation of T0 to T4 percent change. Missing data arises from a combination of participant withdrawal/loss to followup and poor ultrasound data quality. | Posted | Mean | Standard Deviation | % change | Comparing T0 (day 0) and T4 (day 360) |
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| Secondary | Percent Change of High Sensitivity C-reactive Protein (Hs-CRP) | Percent change of hs-CRP (mg/dL) from day 0 to day 360 [(CRP@T4 - CRP@T0) / CRP@T0] | Analysis population includes only participants for whom biomarker data was available at T0 and T4 time points. | Posted | Mean | Standard Deviation | % change | Comparing T0 (day 0) and T4 (day 360) |
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| Secondary | Percent Change in Total Cholesterol | Percent change of total cholesterol (mg/dL) from day 0 to day 360 [(tchol@T4 - tchol@T0) / tchol@T0] | Analysis population includes only participants for whom biomarker data was available at T0 and T4 time points. | Posted | Mean | Standard Deviation | % change | Comparing T0 (day 0) and T4 (day 360) |
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| Secondary | Percent Change in Low Density Lipoprotein (LDL) Cholesterol | Percent change of low density lipoproteins (LDL) cholesterol (mg/dL) from day 0 to day 360 [(LDL@T4 - LDL@T0) / LDL@T0] | Analysis population includes only participants for whom biomarker data was available at T0 and T4 time points. | Posted | Mean | Standard Deviation | % change | Comparing T0 (day 0) and T4 (day 360) |
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| Secondary | Percent Change in Triglycerides | Percent change of triglycerides (mg/dL) from day 0 to day 360 [(trig@T4 - trig@T0) / trig@T0] | Analysis population includes only participants for whom biomarker data was available at T0 and T4 time points. | Posted | Mean | Standard Deviation | % change | Comparing T0 (day 0) and T4 (day 360) |
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| 1 |
| 73 |
| 1 |
| 73 |
| 0 |
| 73 |
| EG001 | Treatment Group | The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS & PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement. | 0 | 80 | 0 | 80 | 0 | 80 |
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| D004700 | Endocrine System Diseases |