Metronidazole and Amoxicillin for the Treatment of Type 2 Diabetic Subjects With Periodontitis
NCT ID: NCT02135952
Last Updated: 2014-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
58 participants
INTERVENTIONAL
2011-09-30
2014-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dose and Duration of Metronidazole and Amoxicillin for Treatment of Chronic Periodontitis
NCT02735395
Amoxicillin and Metronidazole During Periodontal Treatment
NCT02954393
The Effects of Periodontal Therapy on Glycemic Control in Diabetic Patients
NCT03783845
Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment
NCT03933501
MTZ Plus AMX in the Treatment of Smokers and Non-smokers
NCT01837199
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SRP+MTZ+AMX
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
SRP in four to six appointments lasting approximately 1 h each, using manual curettes and ultrasonic device under local anesthesia.
MTZ+AMX
Administration of antibiotics (metronidazole and amoxicillin) for 14 days started immediately after the first session of SRP.
SRP+placebo
Scaling and root planing + placebo
SRP
SRP in four to six appointments lasting approximately 1 h each, using manual curettes and ultrasonic device under local anesthesia.
Placebo
Administration of placebo for 14 days started immediately after the first session of SRP.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SRP
SRP in four to six appointments lasting approximately 1 h each, using manual curettes and ultrasonic device under local anesthesia.
Placebo
Administration of placebo for 14 days started immediately after the first session of SRP.
MTZ+AMX
Administration of antibiotics (metronidazole and amoxicillin) for 14 days started immediately after the first session of SRP.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of type 2 DM for ≥ 5 years
* DM treatment with diet and insulin supplementation or oral hypoglycemic agents
* Glycated hemoglobin (HbA1c) levels ≥ 6.5% ≤ 11%
* At least 15 teeth
* More than 30% of the sites with probing depth (PD) and clinical attachment level (CAL) ≥ 4 mm
* Minimum of six teeth with at least one site with PD and CAL ≥ 5 mm and bleeding on probing (BoP) at baseline.
Exclusion Criteria
* Lactation
* Current smoking
* Smoking within the past 5 years
* Scaling and root planing (SRP) in the previous 12 months
* Antimicrobial therapies during the previous 6 months
* Medical conditions requiring prophylactic antibiotic coverage
* Continuous use of mouthrinses containing antimicrobials in the preceding 3 months
* Systemic conditions (except DM) that could affect the progression of periodontitis (e.g. immunological disorders, osteoporosis)
* Long-term administration of anti-inflammatory
* Long-term administration of immunosuppressive medications
* Allergy to metronidazole and/or amoxicillin
* Presence of periapical pathology
* Use of orthodontic appliances
* Presence of extensive prosthetic rehabilitation
* Major complications of DM (i.e. cardiovascular and peripheral vascular diseases \[ulcers, gangrene and amputation\], neuropathy and nephropathy)
35 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Guarulhos
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Poliana Mendes Duarte
PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Poliana M Duarte, PhG
Role: PRINCIPAL_INVESTIGATOR
University of Guarulhos
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Guarulhos
Guarulhos, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Lang NP, Tonetti MS. Periodontal risk assessment (PRA) for patients in supportive periodontal therapy (SPT). Oral Health Prev Dent. 2003;1(1):7-16.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013/01072-5
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SISNEP/697
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.