Full-mouth Periodontal Debridement and Metronidazole Gel in Patients With Chronic Periodontitis
NCT ID: NCT01938183
Last Updated: 2013-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2006-11-30
2011-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Full-mouth PD+placebo gel
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.
Full-mouth periodontal debridement
full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour
placebo gel
semi-solid suspension containing carbopol
Full-mouth PD+Metronidazole tablet
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.
Full-mouth periodontal debridement
full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour
Metronidazole tablet
750 mg metronidazole tablets
Full-mouth PD+Metronidazole benzoate gel
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.
Full-mouth periodontal debridement
full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour
Metronidazole benzoate gel
15% Mtz benzoate in semi-solid suspension containing carbopol (gel)
Interventions
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Full-mouth periodontal debridement
full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour
Metronidazole tablet
750 mg metronidazole tablets
placebo gel
semi-solid suspension containing carbopol
Metronidazole benzoate gel
15% Mtz benzoate in semi-solid suspension containing carbopol (gel)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
21 Years
70 Years
ALL
No
Sponsors
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Faculty Sao Leopoldo Mandic Campinas
OTHER
University of Campinas, Brazil
OTHER
Responsible Party
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Francisco Groppo
Full Professor
Principal Investigators
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Cristiane C Bergamaschi, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Campinas, Brazil
Francisco C Groppo, PhD
Role: STUDY_CHAIR
University of Campinas, Brazil
Locations
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Piracicaba Dental School
Piracicaba, São Paulo, Brazil
Countries
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References
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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, 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.
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.
Other Identifiers
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MTZ085-2006
Identifier Type: -
Identifier Source: org_study_id