comparative evaluation of pin hole surgical technique and semilunar coronally repositioned flap for treatment of gingival recession
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To evaluate and compare the clinical outcome of Pin hole surgical technique and Semilunar coronally advanced flap in maxillary anterior region of Miller’s class I gingival recession.
研究概览
简要总结
Intervention/ Procedure:
Procedure performed by a singleoperator. The patients’ will be explained about the surgical procedures (AppendixI) and the possible outcomes in their vernacular language as well as writteninformed consent (Appendix II) shall be obtained. The demographic data of allthe subjects will be recorded on the customized case history proforma (AppendixIII).
The study will be conducted inpatients with single or multiple Miller’s class I gingival recession defects.Clinical parameters like recession height (RH), the distance from the CEJ togingival margin, recession width (RW), meiso-distal diameter at the CEJ,probing sulcus depth (PD), clinical attachment level (CAL), the sum ofrecession depth and probing depth, and width of keratinized tissue (KTW) i.e.,distance from marginal gingiva to the mucogingival junction will be assessed.
In case of semilunar coronally repositioned flap, asemilunar incision, will be given following the curvature of the free gingivalmargin. The incision will curve apically far enough mid facially to ensure thatthe apical part of the flap rests on bone after it is brought down to cover theexposed root.
Incision will end into the papillae on each end ofthe tooth, but not all the way to the tip of the papillae, at least 2 mm willbe left on either side of the flap. Using a 15c blade, split thicknessdissection will be made from the initial incision line coronally, connectedwith an intrasulcular incision made mid facially.
Mid facial tissue will be then coronally positionedto the CEJ or to the height of adjacent papillae in case of interproximalrecession. Tissue will be held in place against the tooth with moist gauze for5 min.
In case of pin hole surgical technique, a minimalhorizontal incision of 2 to 3mm will be made in the alveolar mucosa near thebase of the vestibule apical to recipient site. Specially designed instruments[Transmucosal periosteal elevators right and left] are inserted through theentry of incision to elevate full thickness flap and will be guided byvisualization of the shape and movement of the instruments through the mucosaand gingival tissue. This interproximal extension of the flap will result in afreely movable flap, which will be then positioned coronally to extend beyondthe CEJ. For stabilization of flap, sutures will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Presence of maxillary single or multiple buccal recessions in the anterior region classified as class I
- •Absence of restoration or crowns and non-identifiable cemento-enamel junction(CEJ)
- •Plaque and bleeding score should be <25%.
排除标准
- •Systemically compromised individuals with diabetes mellitus, history of malignancies, bleeding disorders or any other chronic inflammatory disease eg-rheumatoid arthritis.
- •Pregnant women and lactating mothers.
- •Patients on antibiotic therapy.
- •Patients who underwent any surgical periodontal therapy in the last six months.
结局指标
主要结局
To evaluate and compare the clinical outcome of Pin hole surgical technique and Semilunar coronally advanced flap in maxillary anterior region of Miller’s class I gingival recession.
时间窗: baseline, 3 months and 6 months post-operatively.
次要结局
- To assess the recession coverage in pin hole surgical technique.(To assess the recession coverage in semilunar coronally repositioned flap technique.)