Chronic Periodontitis
Conditions
Keywords
chronic periodontitis, metronidazole
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.
Interventions
PROCEDUREFull-mouth periodontal debridement
full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour
750 mg metronidazole tablets
DRUGplacebo gel
semi-solid suspension containing carbopol
DRUGMetronidazole benzoate gel
15% Mtz benzoate in semi-solid suspension containing carbopol (gel)
Sponsors
Faculty Sao Leopoldo Mandic Campinas
University of Campinas, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in PPD | Change from baseline to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in microbiological biofilm composition | Change from baseline to 6 months | Subgingival biofilm samples were collected from five pockets of each patient, present 5-6mm at the baseline period in a single root tooth. |
| Changes in VPI | Change from baseline to 6 months | Visible plaque index (VPI) measured on four tooth surfaces: mesial, distal, buccal and lingual. Measurements were performed by a calibrated clinician. |
| Changes in GBI | Change from baseline to 6 months | Gingival bleeding index (GBI) measured on four tooth surfaces: mesial, distal, buccal and lingual. Measurements were performed by a calibrated clinician. |
| Changes in RAL | Change from baseline to 6 months | Relative attachment level (RAL) measured from the stent to the bottom of periodontal pocket. Measurements were performed by a calibrated clinician. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Drug use compliance | After 8 days of periodontal treatment | Drug use compliance was measured by salivary drug concentration on the eighth day after periodontal debridement. |
Countries
Brazil
Outcome results
None listed