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| ID | Type | Description | Link |
|---|---|---|---|
| 2013/01072-5 | Other Grant/Funding Number | FAPESP - 2013/01072-5 |
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Diabetes mellitus (DM) is a widely prevalent disease associated with several major systemic and oral complications, such as periodontitis. The use of adjunctive local and/or systemic antimicrobials has been proposed to improve the clinical and glycemic outcomes of the scaling and root planing (SRP) in diabetic subjects. The combination of metronidazole (MTZ) and amoxicillin (AMX) has been largely recognized as an effective therapy for improving the clinical and microbiological outcomes of SRP in the treatment of with chronic periodontitis (ChP). However, no previous clinical trials to date have evaluated the effects of this antibiotic combination in the treatment of diabetic subjects with periodontitis. Therefore, the aim of this randomized clinical trial (RCT) will be to evaluate the clinical and microbiological effects of the use of MTZ+AMX as adjuncts to SRP for the treatment of type 2 diabetic subjects with generalized ChP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRP+MTZ+AMX | Active Comparator | Scaling and root planing (SRP) + metronidazole (MTZ; 400 mg thrice a day [TID] for 14 days) + amoxicillin (AMX; 500 mg TID for 14 days) |
|
| SRP+placebo | Placebo Comparator | Scaling and root planing + placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRP | Procedure | SRP in four to six appointments lasting approximately 1 h each, using manual curettes and ultrasonic device under local anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in number of sites with probing depth (PD) ≥5 mm post-treatment | From baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| PD and clinical attachment level (CAL) changes at initially moderate sites | From baseline to 12 months and from baseline to 24 months | |
| PD and CAL changes at initially deep sites | From baseline to 12 months and from baseline to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Poliana M Duarte, PhG | University of Guarulhos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Guarulhos | Guarulhos | São Paulo | 07023-070 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22706234 | Background | Amid R, Tabeie MB, Kadkhodazadeh M, Mehdizadeh AR, Youssefi N. Local concentration of systemic amoxicillin and metronidazole in healthy and inflamed gingiva: a comparative in vivo study. Drug Metabol Drug Interact. 2012 May 10;27(2):113-8. doi: 10.1515/dmdi-2012-0003. | |
| 23627324 | Background | Borgnakke WS, Ylostalo PV, Taylor GW, Genco RJ. Effect of periodontal disease on diabetes: systematic review of epidemiologic observational evidence. J Clin Periodontol. 2013 Apr;40 Suppl 14:S135-52. doi: 10.1111/jcpe.12080. |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D044882 | Glucose Metabolism Disorders |
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| Placebo | Other | Administration of placebo for 14 days started immediately after the first session of SRP. |
|
| MTZ+AMX | Drug | Administration of antibiotics (metronidazole and amoxicillin) for 14 days started immediately after the first session of SRP. |
|
| Changes in number of sites with PD ≥5mm | From baseline to 12 months and from baseline to 24 months |
| Full-mouth PD and CAL | Baseline, 3, 6, 12 and 24 months |
| Full-mouth percentages of sites with plaque | Baseline, 3, 6, 12 and 24 months |
| Full-mouth percentages of sites with marginal bleeding | Baseline, 3, 6, 12 and 24 months |
| Full-mouth percentages of sites with bleeding on probing | Baseline, 3, 6, 12 and 24 months |
| Full-mouth percentages of sites with suppuration | Baseline, 3, 6, 12 and 24 months |
| Full-mouth percentages of sites with PD ≥5mm | Baseline, 3, 6,12 and 24 months |
| Serum levels of glycated hemoglobin (HbA1c) | Baseline, 3, 6, 12 and 24 months |
| Serum levels of fasting plasma glucose FPG | Baseline, 3, 6, 12 and 24 months |
| Levels of periodontal pathogenic bacterial species | Baseline, 3, 6, 12 and 24 months |
| Occurrence of adverse events | 14 days |
| 19254119 | Background | Cionca N, Giannopoulou C, Ugolotti G, Mombelli A. Amoxicillin and metronidazole as an adjunct to full-mouth scaling and root planing of chronic periodontitis. J Periodontol. 2009 Mar;80(3):364-71. doi: 10.1902/jop.2009.080540. |
| 20059413 | Background | Cionca N, Giannopoulou C, Ugolotti G, Mombelli A. Microbiologic testing and outcomes of full-mouth scaling and root planing with or without amoxicillin/metronidazole in chronic periodontitis. J Periodontol. 2010 Jan;81(1):15-23. doi: 10.1902/jop.2009.090390. |
| 19728628 | Background | Feres M. Antibiotics in the treatment of periodontal diseases: microbiological basis and clinical applications. Ann R Australas Coll Dent Surg. 2008 Jun;19:37-44. |
| 23016867 | Background | Feres M, Soares GM, Mendes JA, Silva MP, Faveri M, Teles R, Socransky SS, Figueiredo LC. Metronidazole alone or with amoxicillin as adjuncts to non-surgical treatment of chronic periodontitis: a 1-year double-blinded, placebo-controlled, randomized clinical trial. J Clin Periodontol. 2012 Dec;39(12):1149-58. doi: 10.1111/jcpe.12004. Epub 2012 Sep 27. |
| 9287060 | Background | Grossi SG, Skrepcinski FB, DeCaro T, Robertson DC, Ho AW, Dunford RG, Genco RJ. Treatment of periodontal disease in diabetics reduces glycated hemoglobin. J Periodontol. 1997 Aug;68(8):713-9. doi: 10.1902/jop.1997.68.8.713. |
| 23040240 | Background | Jimenez M, Hu FB, Marino M, Li Y, Joshipura KJ. Type 2 diabetes mellitus and 20 year incidence of periodontitis and tooth loss. Diabetes Res Clin Pract. 2012 Dec;98(3):494-500. doi: 10.1016/j.diabres.2012.09.039. Epub 2012 Oct 3. |
| 15643744 | Background | Lang NP, Tonetti MS. Periodontal risk assessment (PRA) for patients in supportive periodontal therapy (SPT). Oral Health Prev Dent. 2003;1(1):7-16. |
| 21762197 | Background | Silva MP, Feres M, Sirotto TA, Soares GM, Mendes JA, Faveri M, Figueiredo LC. Clinical and microbiological benefits of metronidazole alone or with amoxicillin as adjuncts in the treatment of chronic periodontitis: a randomized placebo-controlled clinical trial. J Clin Periodontol. 2011 Sep;38(9):828-37. doi: 10.1111/j.1600-051X.2011.01763.x. Epub 2011 Jul 15. |
| 22612369 | Background | Zandbergen D, Slot DE, Cobb CM, Van der Weijden FA. The clinical effect of scaling and root planing and the concomitant administration of systemic amoxicillin and metronidazole: a systematic review. J Periodontol. 2013 Mar;84(3):332-51. doi: 10.1902/jop.2012.120040. Epub 2012 May 21. |
| 27013640 | Derived | Tamashiro NS, Duarte PM, Miranda TS, Maciel SS, Figueiredo LC, Faveri M, Feres M. Amoxicillin Plus Metronidazole Therapy for Patients with Periodontitis and Type 2 Diabetes: A 2-year Randomized Controlled Trial. J Dent Res. 2016 Jul;95(7):829-36. doi: 10.1177/0022034516639274. Epub 2016 Mar 24. |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |