Coronally Advanced Flap and PRF With or Without Demineralized Freeze-dried Bone Allograft in Gingival Recession
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 主要终点
- Recession Depth (RD)
研究概览
简要总结
- Gingival recession is defined as the apical migration of gingival margin beyond cemento-enamel junction with the exposure of root surface. More than 20% of the population presents one or more tooth surfaces with gingival recession.
- The main conditions leading to the development of this defect are gingival anatomical factors, chronic trauma, periodontitis, malposed tooth and dentinal hypersensitivity.
- The main goal of treating gingival recession is to restore the gingival margin to cement-enamel junction (CEJ) and normal sulcus with a functional attachment.
- A recent innovation in Guided Tissue Regeneration (GTR) technique is the use of second generation platelet concentrate, called as Platelet-Rich Fibrin membrane (PRF) that contains growth factors and cicatricial properties for root coverage procedures.
- Space is necessary to provide a channel for the migration of progenitor cells towards and on the denuded root surface, where they can differentiate into cementum and periodontal ligament cells.
- Since the gingival recession defects are non-space making, it may be difficult using the membrane technique alone, and hence, the use of a graft material underneath the membrane may help to resolve this problem. Root coverage tended to be better with the addition of demineralized freeze-dried bone allograft (DFDBA). These allografts prevent the collapse of membrane into the defect, stimulate the proliferation of osteogenic progenitor cells, and are thus, capable of promoting regeneration of attachment apparatus.
- Till date, no study is available in the literature on clinical evaluation of CAF (Coronally Advanced Flap)+PRF+DFDBA vs CAF+PRF for the management of gingival recession defects.
- And hence, this study is designed to evaluate the clinical efficacy of DFDBA (Rocky Mountain Particulate Allograft) for the management of isolated gingival recession defects.
详细描述
SURGICAL PROCEDURE:
I. After patient selection and obtaining informed consent, a total of 10 bilateral facial, Miller's Class I or II gingival recession defects were consecutively treated. Test and Control site were randomly assigned by flip coin technique.
II. The Test sites were treated using CAF+PRF+DFDBA and the Control sites were treated using CAF+PRF.
III. Under local anesthesia, an intrasulcular incision was given using a surgical bade on the buccal aspect of the involved tooth. The incision was extended horizontally to dissect the buccal aspect of the adjacent papillae, both mesially and distally, leaving the gingival margin of the adjacent teeth untouched. Two oblique releasing incisions were made from the mesial and distal extremities of the horizontal incision beyond the mucogingival junction.
IV. Partial-full-partial thickness flap was raised and extended beyond the mucogingival junction. The exposed root surface was thoroughly debrided and prepared to reduce the root convexities, if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age group of 18-45 years from both sexes.
- •Presence of bilateral isolated gingival recession classified as Miller's class I or class II recession defects in anteriors and/or premolars.
- •Systemically healthy patients.
- •Patients willing to comply with all study-related procedures and available for follow-up.
- •Ability to maintain good oral hygiene.
排除标准
- •History of prolonged use of antibiotics/steroids/immunosuppressive agents/aspirin/ anticoagulants/other medications.
- •Pregnant/Lactating women.
- •Tobacco in any form.
- •History of systemic diseases like hypertension, diabetes, HIV, bone metabolic disorders, radiation therapy, immunosuppressive therapy, cancer.
- •Patients with unacceptable oral hygiene.
- •Faulty tooth brushing technique.
- •Malaligned teeth.
- •Cervical abrasion.
- •Unwilling patients.
结局指标
主要结局
Recession Depth (RD)
时间窗: Change from Baseline Recession Depth at 6 months.
Recession depth (RD), measured from the cemento-enamel junction (CEJ) to the most apical extension of gingival margin at Baseline and 6 months post-surgery.
次要结局
- Relative Attachment Level (RAL)(Change from Baseline Relative Attachment Level at 6 months.)
- Probing Depth(Change from Baseline Probing Depth at 6 months.)
- Width of Keratinized Gingiva (WKG)(Change from Baseline Width of Keratinized Gingiva at 6 months.)
- Percentage of Root Coverage(At 6 months.)
研究者
POONAM DHOLAKIA
Dr. Poonam Dholakia
Dr. D. Y. Patil Dental College & Hospital