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

NCT01938183 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-09-10

No results posted yet for this study

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.

Conditions

  • Chronic Periodontitis

Interventions

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)

Sponsors & Collaborators

  • Faculty Sao Leopoldo Mandic Campinas

    collaborator OTHER

  • University of Campinas, Brazil

    lead OTHER

Principal Investigators

  • Cristiane C Bergamaschi, PhD · University of Campinas, Brazil

  • Francisco C Groppo, PhD · University of Campinas, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2010-03-31
Completion
2011-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01938183 on ClinicalTrials.gov