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

Information source: University of Campinas, Brazil
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Periodontitis

Intervention: Full-mouth periodontal debridement (Procedure); Metronidazole tablet (Drug); placebo gel (Drug); Metronidazole benzoate gel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Campinas, Brazil

Official(s) and/or principal investigator(s):
Cristiane C Bergamaschi, PhD, Principal Investigator, Affiliation: University of Campinas, Brazil
Francisco C Groppo, PhD, Study Chair, Affiliation: University of Campinas, Brazil


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Changes in PPD

Secondary outcome:

Changes in microbiological biofilm composition

Changes in VPI

Changes in GBI

Changes in RAL

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.


Minimum age: 21 Years. Maximum age: 70 Years. Gender(s): Both.


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


- 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)

Locations and Contacts

Piracicaba Dental School, Piracicaba, SP 13414903, Brazil
Additional Information

Related publications:

Lorentz TC, Cota LO, Cortelli JR, Vargas AM, Costa FO. Prospective study of complier individuals under periodontal maintenance therapy: analysis of clinical periodontal parameters, risk predictors and the progression of periodontitis. J Clin Periodontol. 2009 Jan;36(1):58-67. doi: 10.1111/j.1600-051X.2008.01342.x. Epub 2008 Oct 30.

Carvalho LH, D'Avila GB, Leão A, Gonçalves C, Haffajee AD, Socransky SS, Feres M. Scaling and root planing, systemic metronidazole and professional plaque removal in the treatment of chronic periodontitis in a Brazilian population II--microbiological results. J Clin Periodontol. 2005 Apr;32(4):406-11.

Moeintaghavi A, Talebi-ardakani MR, Haerian-ardakani A, Zandi H, Taghipour S, Fallahzadeh H, Pakzad A, Fahami N. Adjunctive effects of systemic amoxicillin and metronidazole with scaling and root planing: a randomized, placebo controlled clinical trial. J Contemp Dent Pract. 2007 Jul 1;8(5):51-9.

Starting date: November 2006
Last updated: September 4, 2013

Page last updated: August 23, 2015

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