Clinical Efficacy of Subgingivally Delivered 0.75% Boric Acid Gel As An Adjunct to Mechanotherapy in Chronic Periodontitis: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 主要终点
- Defect depth reduction (%)
研究概览
简要总结
The purpose of the present study was to evaluate the effects of subgingival delivery of boric acid gel as an adjunct to scaling and root planing in chronic periodontitis (CP) patients.
详细描述
Background: The purpose of this double-masked, randomized, controlled clinical trial was to evaluate the effects of subgingival delivery of boric acid gel as an adjunct to scaling and root planing (SRP) on clinical and radiographic parameters and compare this method with SRP plus placebo gel alone in with chronic periodontitis (CP) patients.
Methods: Thirty nine systemically healthy patients with CP are included in this study. They were divided into two groups: 1) SRP + 0.75% Boric acid gel (BA group); 2) SRP + Placebo gel (Placebo group). At baseline, 3 month, and 6 months after treatment, clinical measurements, including plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL) and radiographic parameters intrabony defect depth (IBD), percentage change in radiographic defect depth reduction (DDR%) were assessed.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy with deep pockets (PD of ≥5mm or CAL ≥4mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs
- •Patients with ≥20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy
排除标准
- •Patients on systemic boron therapy
- •Known or suspected allergy to boron supplementation
- •Patients with aggressive periodontitis
- •Tobacco use in any form, smokers, alcoholics
- •Immunocompromised and systemically unhealthy patients
- •Pregnant or lactating females
研究组 & 干预措施
Boric acid group
Oral prophylaxis followed by 0.75% boric acid drug in gel form placed in intrabony defects
干预措施: SRP plus boric acid gel (Drug)
Placebo group
Oral prophylaxis followed by placebo gel placement in intrabony defects
干预措施: SRP plus placebo gel (Drug)
结局指标
主要结局
Defect depth reduction (%)
时间窗: Change from baseline to 6 months
assessed in percentage
次要结局
- plaque index(Change from baseline to 6 months)
- clinical attachment level (mm)(Change from baseline to 6 months)
- modified sulcus bleeding index(Change from baseline to 6 months)
- probing depth (mm)(Change from baseline to 6 months)
研究者
Dr. A R Pradeep
Professor and Head, Dept of Periodontology
Government Dental College and Research Institute, Bangalore