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临床试验/CTRI/2024/05/067734
CTRI/2024/05/067734已完成4 期

Comparative evaluation of the clinical outcomes of xenogeneic pericardial collagen membrane enriched with two different forms of platelet concentrates in the treatment of gingival recession- A prospective study

kiran choudhary1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年6月24日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
To assess and compare the changes in the recession height from baseline to 6 months, within and between the study groups

研究概览

简要总结

Gingival recession is a common  periodontal condition where the apical migration of gingival tissue causes exposure of the root surface and results in hypersensitivity, root caries , esthetic concerns to patients. The coronally advanced flap (CAF) along with connective tissue graft (CTG) is one of the most effective techniques for the management of Miller Class I and II recessions because it offers excellent esthetic results, highest root coverage. However, in patients with multiple gingival recession defects and having thin gingival phenotype, harvesting CTGs of adequate dimensions are clinically challenging due to the limited donor area. Recently the animal derived xenogeneic collagen membrane along with platelet concentrates have gained attention in successful root coverage procedures . In this study we are proposing to compare the efficacies of xenogeneic collagen membrane along with two different types of platelet concentrates, that is, injectable platelet rich fibrin versus advanced platelet rich fibrin plus

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy subjects with an age range of 18-65 years.
  • Individuals diagnosed with recession defects in maxillary anteriors and premolars (Cairo’s RT1 , RT2 classes of recession)
  • Sites with minimum depth of recession ≥2mm.
  • Isolated or multiple adjoining recession involving ≤3 teeth.

排除标准

  • Sites with probing pocket depth ≥4mm.
  • 2.Teeth with mobility and/or associated with trauma from occlusion.
  • Sites with dental caries and prosthetic restorations.
  • Patients who exhibit unacceptable oral hygiene compliance during/or after phase Ι therapy.
  • Pregnant and lactating women.
  • 7.Patient known allergic response with equine derived substances.
  • 8.Patients with known platelet disorders or using any medication that are known to interfere with platelet function.
  • Patients with systemic conditions or disease influencing the course of periodontal disease and therapy.

结局指标

主要结局

To assess and compare the changes in the recession height from baseline to 6 months, within and between the study groups

时间窗: Baseline and 6months

次要结局

  • 1. To assess and compare the percentage of complete root coverage (CRC%) achieved at 6 months between the research groups(2.To assess and compare the patient perception regarding esthetics following the treatment modalities by using Visual Analogue Scale scores (VAS-E))

研究者

发起方
kiran choudhary
申办方类型
Other [Self funded ]
责任方
Principal Investigator
主要研究者

Kiran choudhary

SRM dental college

研究点 (1)

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