Comparison of low level laser therapy in conjunction with diode laser & I-PRF with microneedling assisted vestibuloplasty for keratinised layer differentiation & vestibular depth gain - A Randomised clinical trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To compare and evaluate the vestibular depth and width of keratinised gingiva, keratinized tissue thickness after injecting I-PRF following Microneedling and Laser Vestibuloplasty using Laser Biostimulation.
研究概览
简要总结
This is double-blind randomized clinical trial, Which compares the effects of low level laser therapy in conjunction with diode laser and microneedling with I-PRF injection assisted vestibuloplasty for keratinized layer differentiation and vestibular depth gain. The study evaluates primary hypothesis as Are there any changes in vestibular depth and width of keratinized gingiva using two different methods in patient having inadequate vestibular depth.
The primary outcome measures will be increase in vestibular depth, keratinized tissue width and keratinized tissue thickness. Recession depth, clinical attachment loss, probing pocket depth are the secondary outcome will be measured at baseline , 3 months, and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female above 16 years of age.
- •2.Patient with inadequate vestibular depth.
- •3.Patient with narrow keratinized gingiva.
- •4.Single or multiple gingival recession.
- •5.Abberant frenal attachment.
排除标准
- •1.Medically compromised patient.
- •2.Patient not willing to participate in the study.
结局指标
主要结局
To compare and evaluate the vestibular depth and width of keratinised gingiva, keratinized tissue thickness after injecting I-PRF following Microneedling and Laser Vestibuloplasty using Laser Biostimulation.
时间窗: vestibular depth & width of keratinised gingiva, thickness of keratinized tissue- time point baseline, 3 months & 6 months.
次要结局
- Gingival recession depth, clinical attachment loss, probing pocket depth are the secondary outcomes.(Gingival recession depth, clinical attachment loss, probing pocket depth - time points baseline, 3 months, 6 months.)
研究者
DrVikas Gopalghare
Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental college,Dhule