NCT01938183

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

Full-mouth Periodontal Debridement With or Without Adjunctive Metronidazole Gel in Smoking Patients With Chronic Periodontitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Chronic Periodontitis

Interventions

Type	Name	Description
PROCEDURE	Full-mouth periodontal debridement	full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour
DRUG	Metronidazole tablet	750 mg metronidazole tablets
DRUG	placebo gel	semi-solid suspension containing carbopol
DRUG	Metronidazole benzoate gel	15% Mtz benzoate in semi-solid suspension containing carbopol (gel)

Timeline

• Start date: 2006-11-01
• Primary completion: 2010-03-01
• Completion: 2011-12-01
• First posted: 2013-09-10
• Last updated: 2013-09-10

Locations

1 site across 1 country: Brazil