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

University of Guarulhos

Status and phase: Unknown; Phase 4

Conditions: Periodontitis

Treatments: Other: Placebo; Drug: MTZ+AMX; Procedure: SRP

Study type: Interventional

Funder types: Other

Identifiers

NCT02135952

2013/01072-5 (Other Grant/Funding Number)

SISNEP/697

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 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.

Exclusion criteria

• 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
• Major complications of DM (i.e. cardiovascular and peripheral vascular diseases [ulcers, gangrene and amputation], neuropathy and nephropathy)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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58 participants in 2 patient groups, including a placebo group

SRP+MTZ+AMX

Active Comparator group

Description:

Scaling and root planing (SRP) + metronidazole (MTZ; 400 mg thrice a day \[TID\] for 14 days) + amoxicillin (AMX; 500 mg TID for 14 days)

Treatment:

Drug: MTZ+AMX

Procedure: SRP

SRP+placebo

Placebo Comparator group

Description:

Scaling and root planing + placebo

Treatment:

Procedure: SRP

Other: Placebo