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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938183
• Other study ID #: MTZ085-2006
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2013
• Last updated: September 4, 2013
• Start date: November 2006
• Est. completion date: December 2011

Study information

• Verified date: September 2013
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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
• placebo gel
semi-solid suspension containing carbopol
• Metronidazole benzoate gel
15% Mtz benzoate in semi-solid suspension containing carbopol (gel)

Locations

Country	Name	City	State
Brazil	Piracicaba Dental School	Piracicaba	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Faculty Sao Leopoldo Mandic Campinas

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Drug use compliance	Drug use compliance was measured by salivary drug concentration on the eighth day after periodontal debridement.	After 8 days of periodontal treatment	No
Primary	Changes in PPD	Probing pocket depth (PPD) measured from the bottom of the periodontal pocket to the gingival margin were considering four tooth surfaces: mesial, distal, buccal and lingual. Measurements were performed by a calibrated clinician.	Change from baseline to 6 months	No
Secondary	Changes in microbiological biofilm composition	Subgingival biofilm samples were collected from five pockets of each patient, present 5-6mm at the baseline period in a single root tooth.	Change from baseline to 6 months	No
Secondary	Changes in VPI	Visible plaque index (VPI) measured on four tooth surfaces: mesial, distal, buccal and lingual. Measurements were performed by a calibrated clinician.	Change from baseline to 6 months	No
Secondary	Changes in GBI	Gingival bleeding index (GBI) measured on four tooth surfaces: mesial, distal, buccal and lingual. Measurements were performed by a calibrated clinician.	Change from baseline to 6 months	No
Secondary	Changes in RAL	Relative attachment level (RAL) measured from the stent to the bottom of periodontal pocket. Measurements were performed by a calibrated clinician.	Change from baseline to 6 months	No