Clinical trial NCT01938183: Full-mouth Periodontal Debridement and Metronidazole Gel in Patients With Chronic Periodontitis
Official title: Full-mouth Periodontal Debridement With or Without Adjunctive Metronidazole Gel in Smoking Patients With Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Periodontitis
Keywords: chronic periodontitis
metronidazole
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Faculty Sao Leopoldo Mandic Campinas
First posted: 2013-09-10
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in PPD
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Changes in microbiological biofilm composition
timeFrame: Change from baseline to 6 months
measure: Changes in VPI
timeFrame: Change from baseline to 6 months
measure: Changes in GBI
timeFrame: Change from baseline to 6 months
measure: Changes in RAL
timeFrame: Change from baseline to 6 months
Other outcomes:
measure: Drug use compliance
timeFrame: After 8 days of periodontal treatment
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School
state: SP
Study officials:
affiliation: University of Campinas, Brazil
name: Cristiane C Bergamaschi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campinas, Brazil
name: Francisco C Groppo, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Carvalho LH, D'Avila GB, Leao A, Goncalves 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. doi: 10.1111/j.1600-051X.2005.00720.x.
citation: 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.