The Clinical and Patient Morbidity Comparison of De-Epithelialized Gingival Graft With or Without Platelet Rich Fibrin in Multiple Gingival Recessions: A Split-mouth, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- percentage of root coverage
研究概览
简要总结
The aim of this study is to compare the clinical efficacy and patient reported outcome measures of de-epithelialized gingival graft (DGG) with or without platelet rich fibrin on treatment of multiple adjacent gingival recessions with coronally advanced flap (CAF) technique.
详细描述
Fifteen patients with split-mouth multiple gingival recessions affecting at least 3 adjacent teeth will be treated with either DGG or DGG+PRF. Recession depth(RD) and width(RW), probing depth(PD), clinical attachment level(CAL), keratinized tissue width (KTW), gingival thickness(GT), and percentage of root coverage (RC%) will be evaluated at 1, 3 and 6 months postoperatively. For patient reported outcome measurements, oral health impact factor-14 (OHIP-14) scores, postoperative pain, bleeding, discomfort and painkiller consumption will be recorded.
A total of 15 patients will surgically treated with coronally advanced flap (CAF) associated with de-epithelialized gingival graft. Groups were defined as DGG and DGG+PRF:
DGG Group (n=15): de-epithelialized subepithelial connective tissue grafts + coronally advanced flap DGG+PRF Group (n=15): de-epithelialized subepithelial connective tissue grafts+ L-Platelet Rich Fibrin + Coronally advanced flap
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
- Double (Investigator, Outcomes Assessor)
盲法说明
All clinical measurements will be measured and recorded by the blinded researcher. Treatment assignment and surgeries will have been unknown to this examiner. For statistically analysis, groups will be anonymized.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •of participants were as belows:
- •Age > 18 years Systemically healthy and non-smoker Full-mouth plaque index and full-mouth gingival index score< 20% No mucogingival surgery experience at operation area No active periodontal disease Patients who have not received orthodontic treatment
排除标准
- •of participants were as belows:
- •Pregnancy and lactation Bruxism or occlusal trauma Medical contradictions and for periodontal plastic surgery (i.e. mental disorders) Medication intake
- •Inclusion criteria of surgical area were as below; Presence of at least three single-rooted teeth (anterior-premolar) with RT1 Class [25] buccal gingival recession defects ≥2 mm in depth Keratinized gingival width<3 mm Sufficient oral hygiene (bleeding on probing <10%, Periodontal Depth<3 mm) Patients without restoration and/or filling in the gingival recession area Absence of non-carious cervical lesions and non-detectable cemento-enamel junction (CEJ) at the defect sites
结局指标
主要结局
percentage of root coverage
时间窗: at 6th month
Percentage of Root Coverage (RC%) were performed with the following formulas. RC%: \[(Preoperative RD-Postoperative RD)/ Preoperative RD\] x 100.
次要结局
未报告次要终点
研究者
Berceste Guler
Assoc Prof
Kutahya Health Sciences University