Comparative evaluation of diode laser-assisted non-surgical debridement versus open flap debridement alone.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- reduction of probing pocket depth
研究概览
简要总结
This randomized controlled, single-blind, split-mouth clinical study will compare diode laser-assisted nonsurgical debridement (Group B) with conventional open flap debridement (Group A) in 18 sites (9 per group) among patients aged 25-55 with probing depth of 5-8 mm. After Phase 1 therapy and re-evaluation,eligible patients undergo site-specific treatment. Group A receives flap reflection, debridement, suturing, and dressing. Group B receives diode laser therapy following scaling, with three cycles at set intervals.Clinical parameters PI, GI, mSBI,PPD,CAL, and GR are recorded at baseline, 3 and 6 months using standardized tools. Patients are blinded to group allocation to reduce bias, and outcomes aim to assess laser therapy as a pateint-friendly alternative. Data will be statistically analyzed,with significance set at p<0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •residual probing depth 5-8 mm.
- •good level of oral hygiene after initial therapy.
- •no discrimination of gender,caste,religion or socio-economic status.
排除标准
- •medically compromised patients.
- •mentally disabled and physically handicapped patients.
- •pregnant women and lactating mothers.
- •use of antibiotics in the previous 6 months.
- •uncooperative and poor oral hygiene patients.
结局指标
主要结局
reduction of probing pocket depth
时间窗: before intervention, after 3 months and 6 months
次要结局
- plaque index,gingival index,modified sulcular bleeding index,clinical attachment level and gingival recession(before intervention, after 3 months and 6 months)
研究者
Dr Deiji Bora
Kothiwal Dental College and Research Centre, Moradabad.