Open-flap Versus Flapless Esthetic Crown Lengthening: 12-month Clinical Outcomes of a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Mean changes in gingival margin
研究概览
简要总结
The aim of this study is to compare the clinical outcomes of open-flap (OF) and flapless (FL) esthetic crown lengthening (ECL) for the treatment of excessive gingival display (EGD). It was hypothesized that the FL surgery would yield similar clinical results to the OF technique up to 12 months. Methods: A split-mouth randomized controlled trial will be conducted in 28 subjects presenting EGD. Contralateral quadrants will receive ECL using OF or FL techniques. Clinical parameters will be evaluated at baseline, 3, 6 and 12 months post-surgeries. The local levels of receptor activator of NF-КB ligand (RANKL) and osteoprotegerin (OPG) will be assessed by ELISA at baseline and 3 months. Patients' perceptions regarding morbidity and esthetical appearance will be also evaluated. Periodontal tissue dimensions will be obtained by computed tomography at baseline and correlated with the changes in the gingival margin (GM).
详细描述
Experimental design and treatment protocols
In this prospective, split-mouth, randomized controlled clinical study, 28 subjects (21 - 40 years old) requiring correction of EGD will received ECL using OF and FL techniques. A computer-generated table randomly distributed the right quadrant to receive OF or FL techniques. Consequently, the contralateral left quadrant was allocated to the other group. The following treatments were performed:
OF (control group; n=28 sides/105 teeth): An internal beveled incision was performed at the buccal aspect of the involved teeth. Afterwards, a sulcular incision was completed to allow gingival tissue removal. A full-thickness mucoperiosteal flap was reflected to remove and remodel bone tissue by means of surgical chisels, as necessary, until a 3mm distance was achieved between the bone crest and the cement-enamel junction (CEJ). The exposed root surfaces were carefully planed with curettes. Interrupted sutures were performed at the papilla to allow GM stabilization in the CEJ position.
FL (test group; n=28 sides/105 teeth): Internal beveled and sulcular incisions and gingival tissue removal were performed as above described for the control group, replacing the GM in the CEJ position. However, the alveolar bone was removed and remodeled, as necessary, using micro chisels, via incisions, without flap elevation. The root surfaces were also carefully planed via incisions. The required distance of 3mm between the bone crest and the CEJ was checked by inserting a periodontal probe into the incision. Sutures were not performed.
After both procedures, canines and central incisors should be at the same length, and the lateral incisor should be 1mm shorter. The same periodontist (F.R.V.) performed all surgeries. Chlorhexidine gluconate mouthwash (0.12%) was prescribed 2x/day for 2 weeks. Analgesics were prescribed to control possible postoperative discomfort. The sutures of control quadrants were removed after 7 days. The surgical time for test and control, starting after anesthesia, was computed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •esthetic concerns regarding excessive gingival display due to altered passive eruption in at least three upper teeth (incisors, lateral, canines or premolars) per half contralateral quadrant.
- •> 21 years old,
- •at least 20 teeth
- •no sites with attachment loss and probing depth (PD) > 3 mm
- •full-mouth plaque, bleeding on probing (BoP) and marginal bleeding (MB) index scores of < 15%
排除标准
- •pregnancy
- •lactation
- •history of smoking
- •antimicrobial and anti-inflammatory therapies in the previous 2 months
- •previous mucogingival surgery at the region to be treated
- •systemic conditions that could affect tissue healing (e.g. diabetes)
- •use of orthodontic appliances
结局指标
主要结局
Mean changes in gingival margin
时间窗: Baseline to 3, 6 and 12 months
次要结局
- RANKL levels(Baseline and 3 months)
- OPG levels(Baseline and 3 months)
- Visible plaque accumulation(Baseline, 3, 6 and 12 months)
- Marginal bleeding(Baseline, 3, 6 and 12 months)
- Bleeding on probing(Baseline, 3, 6 and 12 months)
- Probing depth(Baseline, 3, 6 and 12 months)
- Clinical attachment level(Baseline, 3, 6 and 12 months)
- Keratinized gingiva height(Baseline, 3, 6 and 12 months)
- Patient perceptions(Baseline, 7 days and 6 months)
研究者
Poliana Mendes Duarte
Assistant Professor
University of Guarulhos