Clinical Evaluation of Coronal Advanced Flap and Platelet Rich Fibrin on Root Coverage of Gingival Recessions Over a Period of 24 Month.
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
- Change of percentage of root coverage (PRC) from baseline at 12 and 24 months
研究概览
简要总结
Several surgical techniques and various adjunctive agents have been used to covered Gingival Recession (GR) and promote clinical outcomes. The treatment of the GR more used (gold standard) is the root coverage with surgical procedures and connective tissue graft, but it has limitations due to the conditions of the donor graft. Is necessary develop other biomaterials for these cases.
The platelet rich fibrin is a autologous biomaterial that has gained tremendous momentum having been utilized for a variety of dental and medical procedures including periodontal surgeries. However, results remain contradictory and mainly focus on the hard and soft tissue healing, aesthetics and postoperative discomfort.
The objective of this study was to evaluate the clinical effects of coronal advanced flap (CAF) and CAF + Platelet Rich Fibrin (PRF) on Root coverage (RC) over a period of 24 month.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Split mouth design allowing to evaluate two conditions in the same patients
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the study
- •Healthy males and females of age 18-60 years old
- •Multiple bilateral (maxillary or mandibular) gingival recessions (Miller class І or II)
- •Good oral hygiene (O´Leary index ≤ 15%)
排除标准
- •Active periodontal disease
- •Periodontal surgeries in the last three years
- •Pregnancy or lactation
- •Smokers or alcoholics
- •Platelet dysfunction syndrome or thrombocytopenia
- •Coagulation defects
- •Uncontrolled diabetes
- •Medical contraindications to elective oral surgery procedures
- •Severe immunodeficiencies
- •Oncological history
- •Prosthetic restorations adjacent to gingival recessions
- •Mobility II or III
- •Occlusal contacts excessive
- •Root caries
- •Buccal restaurations Class V
结局指标
主要结局
Change of percentage of root coverage (PRC) from baseline at 12 and 24 months
时间窗: baseline, 1, 3 , 6, 9, 12 and 24 months
Complete root coverage after surgical correction measured in percentage by using periodontal probe. PRC= Preoperative recession depth - Postoperative recession depth X 100 % Preoperative recession depth
次要结局
- Probing depth (PD)(baseline, 1, 3 , 6, 9, 12 and 24 months)
- Gingival bleeding index (IS)(baseline, 1, 3 , 6, 9, 12 and 24 months)
- Vertical gingival recession (VGR)(baseline, 1, 3 , 6, 9, 12 and 24 months)
- Clinical attachment level(CAL)(baseline, 1, 3 , 6, 9, 12 and 24 months)
- Gingival tissue thickness(baseline, 1, 3 , 6, 9, 12 and 24 months)
- Visual analog scale (VAS)(baseline, 1, 3 , 6, 9, 12 and 24 months)
- Evaluation of oral health impact on quality of life, using the Oral Health Impact Profile (OHIP-14) questionnaire.(baseline, 1, 3 , 6, 9, 12 and 24 months)
- Horizontal gingival recession (HGR)(baseline, 1, 3 , 6, 9, 12 and 24 months)
- Keratinized tissue height (KTH)(baseline, 1, 3 , 6, 9, 12 and 24 months)