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
- 48
- 试验地点
- 1
- 主要终点
- Radiographic bone fill
研究概览
简要总结
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 patients with chronic periodontitis (CP).
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 patients with chronic periodontitis (CP).
Methods:FORTY EIGHT 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
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of buccal Class II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) ≥ 5mm and horizontal ≥ PD 3mm after phase I therapy i.e, scaling and root planing (SRP)
- •No history of antibiotic or periodontal therapy in the preceding 6 months
排除标准
- •Systemic conditions known to affect the periodontal status
- •Medications known to affect the outcomes of periodontal therapy
- •Hematological disorders and insufficient platelet count (<200,000/mm3)
- •Pregnancy/lactation
- •Smoking and tobacco use in any form
- •Immunocompromised individuals
- •Those having unacceptable oral hygiene (plaque index [PI] >1.5)
- •Teeth with furcation involvement, non-vital teeth, and carious teeth indicated for restorations and mobility of at least grade II
- •Aggressive periodontitis
研究组 & 干预措施
Group 1
Scaling and Root Planing (SRP) with 0.75% BORIC ACID GEL for treating furcation defect
干预措施: 0.75 % Boric Acid (Drug)
Group 2
Scaling and Root Planing (SRP) with PLACEBO GEL for treating furcation defect.
干预措施: placebo (Drug)
结局指标
主要结局
Radiographic bone fill
时间窗: Baseline to 6 months
assessed in percentage
次要结局
- modified sulcus bleeding index(3 and 6 months)
- probing depth(3 and 6 months)
- Relative vertical attachment leve(3 and 6 months)
- Relative horizontal attachment level(3 and 6 months)
- plaque index(3 and 6 months)
研究者
Dr. A R Pradeep
Professor & Head, Department of Periodontology
Government Dental College and Research Institute, Bangalore