Metronidazole and Amoxicillin for the Treatment of Type 2 Diabetic Subjects With Periodontitis

NCT02135952 | Unknown Phase 4 DMC

• 2 other identifiers: SISNEP/6972013/01072-5
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis

Keywords

Periodontitis; Diabetes

Outcome Measures

Primary Outcomes (1)

• Changes in number of sites with probing depth (PD) ≥5 mm post-treatment

  From baseline to 12 months

Secondary Outcomes (13)

• 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

• 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

Study Arms (2)

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)

Procedure: SRP; Drug: MTZ+AMX

SRP+placebo

PLACEBO COMPARATOR

Scaling and root planing + placebo

Procedure: SRP; Other: Placebo

Interventions

SRP PROCEDURE

SRP in four to six appointments lasting approximately 1 h each, using manual curettes and ultrasonic device under local anesthesia.

SRP+MTZ+AMX; SRP+placebo

Placebo OTHER

Administration of placebo for 14 days started immediately after the first session of SRP.

SRP+placebo

MTZ+AMX DRUG

Administration of antibiotics (metronidazole and amoxicillin) for 14 days started immediately after the first session of SRP.

SRP+MTZ+AMX

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 35 years of age
• 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.

You may not qualify if:

• Pregnancy
• 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

Sponsors & Collaborators

• University of Guarulhos: lead

Study Sites (1)

University of Guarulhos

Guarulhos, São Paulo, 07023-070, Brazil

Location

Related Publications (12)

• 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.

  PMID: 22706234 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.

  PMID: 23627324 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.

  PMID: 19254119 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.

  PMID: 20059413 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.

  PMID: 19728628 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.

  PMID: 23016867 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.

  PMID: 9287060 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.

  PMID: 23040240 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.

  PMID: 15643744 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.

  PMID: 21762197 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.

  PMID: 22612369 BACKGROUND

• 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.

  PMID: 27013640 DERIVED

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Poliana M Duarte, PhG

  University of Guarulhos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 12, 2014
• Study Start: September 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 12, 2014

Record last verified: 2014-05

Locations

BR (1)