Efficacy of a minimally invasive buccal roll technique for peri-implant soft tissue augmentation in the mandibular posterior region - A randomized controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- second stage surgery –
研究概览
简要总结
Introduction
Problem statement - The posterior mandibular sites are found to havethinner peri-implant tissues when compared to theother sites which can make them more prone torecession and collapse of the ridge contour aroundthe implant, affecting the esthetics and peri-implant mucosal health.
Research question - Is a minimally invasive buccal roll techniquebetter in comparison to conventional second stagetechnique in maintaining the natural ridge contour of peri-implant soft tissues in the mandibularposterior region?
Research hypotheses - Minimally invasive buccal roll technique iseffective in maintaining the ridge contour andesthetics of peri-implant soft tissue in themandibular posterior region compared to controlgroup.
Objectives of the study
Primary objectiveTo assess and compare the following outcomesafter a minimally invasive buccal roll/conventionalsecond stage surgery –Bucco-lingual ridge width (RW)Width of keratinized mucosa (KTW)Thickness of keratinized mucosa (MT)
Secondary objectivesTo assess and compare the following outcomesafter a minimally invasive buccal roll/conventionalsecond stage surgery –1. Alveolar crest height2. Probing depth3. Bleeding on probing4. Pink esthetic score
Study procedure
The patients fulfilling the inclusion criteria will berandomized into two groups of test (Modifiedbuccal roll) and control (Conventional secondstage) by computer generated number.The procedure will be performed under localanesthesia in both the groups, in the test group asplit thickness flap will be outlined according tothe dimensions of the underlying coverscrew,further a full thickness flap will be raised from thelingual aspect of the outline and tunnelled on thebuccal aspect.The flap will then be tucked in to the pouch on thebuccal aspect followed by placement of a suitablegingival former.In the control group, a mid crestal incision will begiven at the implant site followed by elevation of afull thickness flap on both buccal and lingualaspect, following which the cover screw will beunscrewed and a suitable gingival former will beplaced along with sutures to approximate the flap.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •No systemic diseases or pregnancy.
- •No probing depths ≥ 5mm.
- •Full-mouth plaque score (FMPS) and full mouth bleeding score (FMBS) ≤ 15% (measured at four sites per tooth).
- •Need of soft tissue augmentation in mandibular posterior sites to maintain the natural ridge contour and increase the thickness of tissue buccolingually.
- •No previous soft tissue augmentation procedure at experimental site.
排除标准
- •Disease affecting connective tissue metabolism Pregnant or lactating women Untreated periodontal disease.
- •Dental implants previously uncovered or applied with a single -stage procedure.
- •No residual keratinized tissue (KT) at experimental area.
- •Radiographs revealing presence of bone on the cover screw.
结局指标
主要结局
second stage surgery –
时间窗: At baseline 3 months 6 months
Thickness of keratinized mucosa (MT)
时间窗: At baseline 3 months 6 months
Width of keratinized mucosa (KTW)
时间窗: At baseline 3 months 6 months
To assess & compare the following outcomes
时间窗: At baseline 3 months 6 months
Bucco-lingual ridge width (RW)
时间窗: At baseline 3 months 6 months
after a minimally invasive buccal roll/conventional
时间窗: At baseline 3 months 6 months
次要结局
- To assess & compare the following outcomes(after a minimally invasive buccal roll/conventional)