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临床试验/NCT03899051
NCT03899051Unknown不适用

Comparative Clinical Evaluation of Platelet Rich Fibrin and Subepithelial Connective Tissue Graft in Interdental Papilla Reconstruction: A Randomized Controlled Clinical Trial

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
36
试验地点
2
主要终点
Gain in papillary height

研究概览

简要总结

Interdental papilla deficiency leads to food impaction, problems with phonetics and an unaesthetic appearance. Reconstruction of the deficient papilla is therefore, important. Perusal of available literature reveals only case reports and case series in the reconstruction of interdental papilla using subepithelial connective tissue graft and platelet rich fibrin autologous graft. Therefore, the current randomized controlled clinical study is intended to compare the effect of platelet rich fibrin and subepithelial connective tissue graft on interdental papilla reconstruction.

详细描述

INTRODUCTION The rising concern for aesthetics has led to a change in the way dentistry is practised. Modern dentistry, no longer is aimed at only restoration of form and function, but restoration of aesthetics as well. Loss of interdental papilla gives rise to numerous problems such as retention of food, phonetic problems and an unaesthetic look. Reconstruction of this lost interdental papilla is one of the most challenging task as the lack of blood supply is a major obstacle in achieving the desired outcome of any attempts at regeneration.

Subepithelial connective tissue graft has been used for root coverage predictably. Studies in the form of case reports and case series have been done utilizing the connective tissue graft harvested from tuberosity, palate etc with encouraging results in the form of complete or partial interdental papilla fill.

Studies have been done to evaluate the usefulness of platelet rich fibrin(PRF) in regeneration of the interdental papilla. Use of PRF for augmentation of interdental papilla prevents the need for a second surgical site and thereby, the related complications associated with creation of a second surgical site.

On comprehensive search of literature, no study has been evident comparing the effect of subepithelial connective tissue graft and PRF for papilla augmentation. Therefore, the purpose of this study is to compare platelet rich fibrin and subepithelial connective tissue graft in interproximal papilla regeneration. The null hypothesis is that there is no significant difference in the clinical outcome for interdental papilla regeneration by platelet rich fibrin and subepithelial connective tissue graft.

Comparative evaluation of the clinical parameters in interdental papilla reconstruction by using platelet rich fibrin (Test group) and subepithelial connective tissue graft (Control group) MATERIALS AND METHODS The present prospective, analytical, randomized clinical trial will be conducted in the Department of Periodontics and Oral Implantology, Post Graduate Institute of Dental Sciences, Rohtak This interventional study includes 36 systemically healthy patients, with class I and class II papillary recession according to Nordland and Tarnow's classification. These will be divided into two groups equally (n = 18) Test group -Papilla reconstruction would be done with platelet rich fibrin Control group -Papilla reconstruction would be done with subepithelial connective tissue graft Patients will be recruited from the outpatient department of Post Graduate Institute of Dental Sciences, Rohtak Single blinding will be adopted where the investigator analysing the results will be unaware to which group the patient belongs.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in the age range of 18-55 years who are systemically healthy.
  • Patients with class I and class II papillary recession according to Nordland and Tarnow's classification.
  • Patients who have completed etiological periodontal therapy (full mouth scaling and root planing) with Plaque index (Silness & Loe) <1, gingival index (Loe & Silness) <1 and showing adequate compliance and willing to participate in the study.

排除标准

  • Patients having systemic diseases such as hypertension, diabetes, hyperthyroidism or on medications that influence the outcome of periodontal therapy.
  • Presence of open contacts in the maxillary anterior region
  • Presence of crowding in the maxillary anterior region.
  • Pregnant and lactating women
  • Patients with active periodontal disease
  • Smokers, tobacco users.

研究组 & 干预措施

Test group

Experimental

Papilla reconstruction would be done with platelet rich fibrin

干预措施: interdental papilla reconstructive surgery with subepithelial connective tissue graft (Procedure)

Control group

Active Comparator

Papilla reconstruction would be done with subepithelial connective tissue graft

干预措施: interdental papilla reconstructive surgery with PRF (Procedure)

结局指标

主要结局

Gain in papillary height

时间窗: 6 months

Papillary height will be measured from apical aspect of contact point to tip of papilla with UNC 15 probe.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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