Full-mouth Periodontal Debridement With or Without Adjunctive Metronidazole Gel in Smoking Patients With Chronic Periodontitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in PPD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Full-mouth periodontal debridement (Procedure)
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.
干预措施: placebo gel (Drug)
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.
干预措施: Full-mouth periodontal debridement (Procedure)
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.
干预措施: Metronidazole tablet (Drug)
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.
干预措施: Full-mouth periodontal debridement (Procedure)
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.
干预措施: Metronidazole benzoate gel (Drug)
结局指标
主要结局
Changes in PPD
时间窗: 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.
次要结局
- Changes in microbiological biofilm composition(Change from baseline to 6 months)
- Changes in VPI(Change from baseline to 6 months)
- Changes in GBI(Change from baseline to 6 months)
- Changes in RAL(Change from baseline to 6 months)
研究者
Francisco Groppo
Full Professor
University of Campinas, Brazil