Efficacy of Pinhole Gum Rejuvenation Compared to Connective Tissue Graft in Treatment of Gingival Recession
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- recession depth
研究概览
简要总结
This study compares the efficacy of root coverage achieved by the Pinhole Surgical Technique (PST) technique and the Connective Tissue Graft (CTG) technique in the treatment of Miller class I and II gingival recession defects. All patients will receive PST in one quadrant and CTG in another quadrant.
The hypothesis being tested is: Pinhole Surgical Technique outcomes are not inferior to those of the Connective Tissue Graft surgical technique.
详细描述
Gingival recession is defined as the apical migration of the marginal gingiva and it leads to root surface exposure. It may be localized to a few sites or generalized to several teeth, and the severity may vary within the same person and between different people.
A variety of surgical techniques have been recommended to attain root coverage, including connective tissue graft, free gingival graft (FGG), pedicle flaps, double papilla grafts, coronally positioned flaps, coronal positioning of previously placed FGG, guided tissue regeneration (GTR), and the use of acellular dermal matrix (ADM), or enamel matrix derivatives. A recently developed technique used to attain root coverage is the Pinhole Surgical Technique (PST) described by Chao. This novel approach involves the separation of the gingiva and periosteum from the underlying bone with instruments inserted through a pinhole created in the vestibular area of the involved tooth while filling underneath the undermined interproximal papilla with strips of a bioresorbable membrane, rather than transferring gingival tissue from the palate to the area of recession. The advantage of this technique is the preservation of the gingival tissues and its blood supply, while freeing the flap from its apical attachment for ease of coronal displacement and adequate root coverage. In addition, the lack of a secondary surgical site may eliminate the accompanying pain and discomfort often reported in root coverage procedures.
The connective tissue graft technique was described by Langer and Langer in 1985, in which the patient's own connective tissue is taken mostly from the palate and used to cover the area of recession. The retro-molar pad area (tuberosity) has also been used because of the thickening of the sub-mucosa in that area. This graft material is carefully sutured into place and a coronally advanced flap placed and sutured over it, while part of the graft can be left exposed. Currently the connective tissue graft (CTG) is the most common and predictable treatment for gingival recession, and is considered the gold standard. Key advantages of the connective tissue graft procedure are the availability of two sources of blood supply to the graft: one from the recipient bed, and the other from the overlying flap, the perfect chromatic integration, an optimal esthetic outcome, and excellent color match. In addition, an increase in the thickness of the gingival tissues and the width of keratinized gingiva has been documented with the ability for creeping attachment which is not possible with the use of bioresorbable collagen membranes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients should be above 18 years old.
- •The presence of Miller's class I or II gingival recession on at least two matching bilateral or contralateral gingival recession defects (≥ 2 mm).
- •Recession defect on maxillary incisors, maxillary and mandibular canines, or premolars.
- •Absence of a history of periodontal surgery at the involved sites in the last 12 months.
- •History of compliance with oral hygiene instructions and periodontal recall.
- •Sufficient palatal or tuberosity donor tissue thickness (> 2mm).
排除标准
- •Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc.
- •Pregnant and lactating women
- •History of allergic reactions to drugs or materials used in the surgery including collagen.
- •Current use of any form of tobacco.
结局指标
主要结局
recession depth
时间窗: 2 weeks preoperative
Recession Depth (RD): Measured in millimeters from the gingival margin at the mid-buccal aspect of the root, to the Cemento-Enamel Junction (CEJ) or relative CEJ.
Change in percentage root coverage is being assessed
时间窗: Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months
Percentage root coverage (%RC): calculated as (\[RD preoperative - RD postoperative\]/RD preoperative) × 100%.
Change in Pain Index is being assessed
时间窗: Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months
Pain index (PN): Pain is recorded on a horizontal pain scale of 0-10. Pain index as follows; Mild for ''0 to 3,'' moderate for ''4 to 6,'' and severe for ''7 to 10.''
Change in (Complete root coverage determined by recession classification, percentage root coverage, and recession depth, Pain Index, Healing Index) is being assessed.
时间窗: Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months
Complete root coverage (CRC): The number of sites that resulted in 100% root coverage.
Change in Healing Index is being assessed
时间窗: Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months
Healing index (HI): A horizontal scale from 1-5 evaluating tissue color, response to palpation, granulation tissue, incision margin, suppuration, adopted from Aleksic. 1 (very poor). 2 (poor). 3 (good). 4 (very good).
次要结局
- change in periodontal parameters (probing depth) is being assessed(baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative)
- Change in periodontal parameters (clinical attachment level) is being assessed(baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative)
- Change in periodontal parameters (gingival index) is being assessed.(baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative)
- change in periodontal parameters (width of keratinized tissue) is being assessed.(baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative)
- Change in periodontal parameters (gingival thickness) is being assessed.(baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative)
研究者
Othman Shibly
Program Director of the Advanced Education Program in Periodontics
State University of New York at Buffalo