Full-mouth Periodontal Debridement and Metronidazole Gel in Patients With Chronic Periodontitis

University of Campinas, Brazil

Status and phase: Completed; Phase 2

Conditions: Chronic Periodontitis

Treatments: Drug: placebo gel; Drug: Metronidazole tablet; Drug: Metronidazole benzoate gel; Procedure: Full-mouth periodontal debridement

Study type: Interventional

Funder types: Other

Identifiers

NCT01938183

MTZ085-2006

Details and patient eligibility

About

Hypothesis: metronidazole gel applied topically after periodontal debridement in smokers volunteers could improve clinical parameters when compared to metronidazole tablets + periodontal debridement. Method: 30 smokers with chronic periodontitis were randomly assigned into 3 groups: periodontal debridement combined with 3 g placebo gel; periodontal debridement combined with daily topical application of 3 g metronidazole benzoate gel (15%); and periodontal debridement combined with a daily single dose of 750 mg metronidazole. Clinical parameters evaluated were visible plaque, gingival bleeding, probing pocket depth and relative attachment level.

Full description

Background. The benefit of adjunctive metronidazole on periodontal procedure in smokers with chronic periodontitis (CP) is uncertain. The authors compared the effect of metronidazole (Mtz) on full-mouth periodontal debridement (PD= 1 hour of ultrasonic calculus/plaque removal) in smokers with CP.

Methods. This pilot study involved 30 Individuals (having at least six teeth with a clinical attachment loss of ≥ 5 mm and probing pocket depth (PPD) of ≥5 mm) that were randomly assigned into three groups (n=10): 1) PD plus 3 g of placebo gel daily topical application 2) PD plus daily topical application of 3 g of 15% Mtz benzoate gel; and 3) PD plus a daily single dose of 750 mg Mtz (Flagyl®). Clinical parameters visible plaque index (VPI), gingival bleeding index (GBI), relative attachment level (RAL) and PPD; and the quantitative analysis (real-time PCR) of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and Tannerella forsythia were assessed baseline, 1, 3 and 6 months after PD.

Enrollment: 30 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of chronic periodontitis
• presence of at least 6 periodontal pockets with a clinical attachment loss of ≥5 mm
• bleeding on probing (BOP)
• radiographic bone loss
• probing pocket depth higher or equal to 5 mm in at least six teeth
• at least 20 teeth in mouth (third molars excluded)
• an established smoking habit (at least 10 cigarettes per day for the past 4 years)

Exclusion criteria

• periapical alterations in qualifying teeth
• medical disorders requiring prophylactic antibiotic therapy or interfering with the treatment
• periodontal treatment in the past 6 months
• use of drugs known to affect periodontal status (antibiotic, anti-inflammatory, anticonvulsant, immunosuppressant and calcium channel blocker) within the past 6 months
• orthodontic therapy
• pregnancy and lactation
• allergy to metronidazole
• any systemic diseases (e.g.: diabetes and immunological disorders)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

Full-mouth PD+placebo gel

Placebo Comparator group

Description:

Full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour + trays with 3 g of placebo gel (semi-solid suspension containing carbopol), overnight, during seven days.

Treatment:

Procedure: Full-mouth periodontal debridement

Drug: placebo gel

Full-mouth PD+Metronidazole tablet

Active Comparator group

Description:

Full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour + single oral dose of 750 mg tablets/day at night, during seven days.

Treatment:

Procedure: Full-mouth periodontal debridement

Drug: Metronidazole tablet

Full-mouth PD+Metronidazole benzoate gel

Active Comparator group

Description:

Full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour + trays with 3 g of 15% Mtz benzoate gel (semi-solid suspension containing carbopol), overnight, during seven days.

Treatment:

Procedure: Full-mouth periodontal debridement

Drug: Metronidazole benzoate gel