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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Procedure: Full-mouth periodontal debridement
* Drug: Metronidazole tablet
* Drug: placebo gel
* Drug: Metronidazole benzoate gel


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Full-mouth PD+placebo gel<br>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. | Procedure: Full-mouth periodontal debridement<br>* full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour<br>* Other names: PD;Drug: placebo gel<br>* semi-solid suspension containing carbopol<br>|
| Active Comparator: Full-mouth PD+Metronidazole tablet<br>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. | Procedure: Full-mouth periodontal debridement<br>* full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour<br>* Other names: PD;Drug: Metronidazole tablet<br>* 750 mg metronidazole tablets<br>* Other names: MTZ tablet;|
| Active Comparator: Full-mouth PD+Metronidazole benzoate gel<br>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. | Procedure: Full-mouth periodontal debridement<br>* full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour<br>* Other names: PD;Drug: Metronidazole benzoate gel<br>* 15% Mtz benzoate in semi-solid suspension containing carbopol (gel)<br>* Other names: MTZ GEL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic periodontitis, metronidazole