Azithromycin as an Adjunct to One- Stage Full-Mouth Disinfection in Stage III Grade B Unstable generalised periodontitis: A Randomized Controlled Clinical Trialâ€
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in Probing Pocket depth (PPD)
研究概览
简要总结
The aim of this randomized clinical trial was to evaluate whether the adjunctive use of systemic azithromycin improves clinical outcomes in the treatment of Stage III Grade B Unstable generalised periodontitis.
Sample size calculation-
Sample size was calculated using the data of the previous studies Gazal Jain et al 2018 by using OpenEpi, version 3,open source calculator—SSMean(calculation shown at the end).The result of the calculation is 28, so a around figure of 30 sample will be undertaken for the study.
Inclusion criteria-
1.Generalized interproximal attachment loss involving at least three teeth apart from molars and ï¬rst incisors.
2.Amount of microbial deposits inconsistent with the severity of periodontal tissue destruction.
3.Patients with a minimum number of 20 teeth.
4.Patients with clinical attachment loss and probing depths (PDs) ≥ 4 mm at 2 sites of a minimum of 12 teeth
5.The patients included in the study should be systemically healthy.
6.Patients with no history of periodontal therapy in the preceding 6 months or under any antibiotic therapy.
7.Patients motivated to have the therapy and willing to complete the follow-up.
Exclusion criteria-
1.Patients with a known or suspected allergy
2.Patients who have undergone periodontal therapy in the last 6 months.
3.Patients with any systemic disorder affecting periodontal health.
4.Patients with infectious conditions other than periodontitis.
5.Chronic alcoholics
6.Patients consuming tobacco in any form and smokers.
7.Immuno-compromised and systemically-unhealthy patients.
8.Pregnant or lactating females.
Material and method- There will be two groups in this study i. Intervantion group ii. Comparator agent. In intervantion group, 15 subjects will be treated with full mouth disinfection (chlorhexidine gel and mouthwash). In comparator agent, 15 subjects will be treated with full mouth disinfection (chlorhexidine gel and mouthwash) with systemic azithromycin 500mg once daily for 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Generalized interproximal attachment loss involving at least three teeth apart from molars and ï¬rst incisors.
- •2.Amount of microbial deposits inconsistent with the severity of periodontal tissue destruction.
- •3.Patients with a minimum number of 20 teeth.
- •4.Patients with clinical attachment loss and probing depths (PDs) ≥ 4 mm at 2 sites of a minimum of 12 teeth 5.The patients included in the study should be systemically healthy.
- •6.Patients with no history of periodontal therapy in the preceding 6 months or under any antibiotic therapy.
- •7.Patients motivated to have the therapy and willing to complete the follow-up.
排除标准
- •1.Patients with a known or suspected allergy 2.Patients who have undergone periodontal therapy in the last 6 months.
- •3.Patients with any systemic disorder affecting periodontal health.
- •4.Patients with infectious conditions other than periodontitis.
- •5.Chronic alcoholics 6.Patients consuming tobacco in any form and smokers.
- •7.Immuno-compromised and systemically-unhealthy patients.
- •8.Pregnant or lactating females.
结局指标
主要结局
Reduction in Probing Pocket depth (PPD)
时间窗: 3 and 6 months
次要结局
- Reduction in Bleeding on Probing (BOP), Gain in Clinical attachment level (CAL)(Reduction in Bleeding on Probing (BOP), Gain in Clinical attachment level (CAL) at 3 and 6 months)