Evaluating and comparing the healing of periodontal flap using cyanoacrylate tissue adhesive alone and along with low level laser therapy
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Periodontal healing assessed using Wound Healing Index (Huang et al., 2005)
研究概览
简要总结
The present study is a prospective, randomized, controlled, single blinded, parallel-group clinical trial that aims to compare three different flap closure techniques: (i) conventional silk sutures, (ii) iso-amyl cyanoacrylate adhesive, and (iii) iso-amyl cyanoacrylate adhesive combined with Low-Level Laser Therapy (940 nm diode laser, 0.5 W, contact mode, 10 seconds). After Phase 1 therapy and re-evaluation, a total of 60 patients requiring flap surgery for chronic periodontitis will be recruited and randomly allocated into three groups, 20 each ; Group A:- Flap closure withbraided silk 3-0 sutures (Ethicon Mersilk, Johnson & Johnson Pvt. Ltd.); Group B:- Flap closure withcyanoacrylate (Iso-amyl cyanoacrylate); **Group C:-**Flap closure withcyanoacrylate (Iso-amyl cyanoacrylate) with prior application of LLLT. Clinical parameters will be assessed at baseline and during follow-up. The primary outcome will be the Wound Healing Index (recorded at 3rd day, 1 week, 2 weeks, and 3 weeks). Secondary outcomes include postoperative pain using the Visual Analogue Scale (VAS) at the same time intervals, Periodontal Pocket Depth (PPD) at baseline and 6 weeks, and the Turesky–Gilmore–Glickman Plaque Index at baseline and 6 weeks. Patients are blinded to group allocation to reduce bias, and outcome aims to assess a minimally invasive alternative for flap closure. 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 2) Good level of oral hygiene after initial therapy 3) No discrimination of gender,caste,religion or socio-economic status.
排除标准
- •Medically compromised patients 2) Mentally disabled and physically handicapped patients 3) Smokers 4) Pregnant women and lactating mothers 5) Presence of acute periodontal or endodontic infections in the proposed surgical area 6) Known allergy to cyanoacrylate 7) History of radiation therapy or chemotherapy within the past year 8) Patients who are uncooperative, unwilling to participate in study and not maintaining oral hygiene properly.
结局指标
主要结局
Periodontal healing assessed using Wound Healing Index (Huang et al., 2005)
时间窗: Post-operative Day 3, Day 7, Day 14 and Day 21
次要结局
- 1) Postoperative pain using Visual Analogue Scale(VAS)(2) Reduction of Probing pocket depth(PPD))
研究者
Dr Kratee Sharma
Kothiwal Dental College and Research Centre, Moradabad