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| Name | Class |
|---|---|
| Faculty Sao Leopoldo Mandic Campinas | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full-mouth PD+placebo gel | Placebo Comparator | 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 PD+Metronidazole tablet | Active Comparator | 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 PD+Metronidazole benzoate gel | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full-mouth periodontal debridement | Procedure | full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristiane C Bergamaschi, PhD | University of Campinas, Brazil | Principal Investigator |
| Francisco C Groppo, PhD | University of Campinas, Brazil | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piracicaba Dental School | Piracicaba | São Paulo | 13414903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19017035 | Background | 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. | |
| 15811059 |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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|
| Metronidazole tablet | Drug | 750 mg metronidazole tablets |
|
|
| placebo gel | Drug | semi-solid suspension containing carbopol |
|
| Metronidazole benzoate gel | Drug | 15% Mtz benzoate in semi-solid suspension containing carbopol (gel) |
|
|
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 |
| 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. |
| 17618330 | Background | 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. |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |