跳至主要内容
临床试验/CTRI/2021/04/032650
CTRI/2021/04/032650尚未招募1/2 期

Efficacy Of Injectable Platelet Rich Fibrin (i-PRF) In Increasing The Gingival Thickness:A Split Mouth Randomised Controlled Clinical Trial

Manasa Budhan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年4月20日最近更新:
适应症

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Gingival thickness

研究概览

简要总结

Gingival biotype is the quality of soft tissue profile surrounding the tooth.Base on gingival thickness(Aimetti et al classification,2008), gingival biotype can be thin gingival biotype(<1mm) and thick gingival biotype(>1mm).Gingival biotype is important for periodontal health,aesthetics and function,and is a predictor of periodontal and peri-implant treatments.Thin gingval biotype can lead to gingival recession as a result of traumatic brushing,orthodontic,restorative and periodontal treatment.Thin gingival biotype also lead to unpredictable post-operative soft tissue healing,graft failure and extensive bone resorption after tooth extraction.Gingival thickness can be enhanced by different methods.Connective tissue graft is the gold standard procedure, but it requires second surgical site and there is limited availability of tissue.Alternative options are acellular dermal matrix and use of platelet concentrates like Platelet rich Plasma (PRP) and Platelet rich Fibrin (PRF). Injectable Platelet rich Fibrin(i-PRF) is a modification of PRF developed in 2014 by lowering spin centrifugation forces in non-glass centrifugation tubes.Studies have reported enhanced gingival thickness with PRP and conventional PRF.The present study is to evaluate the gingival thickness after injection with i-PRF in healthy volunteers with thin gingival biotype.

PROCEDURE: 0.2mli-PRF will be  injected at 6 points of central and lateral incisors on the test side.Contralateral side will be kept as control without i-PRF injection.Gingival thickness will be measured on the day of procedure before injection(baseline),at 3 months and 6 months follow up using a digital vernier calliper.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • •Healthy volunteers Volunteers with thin gingival biotype according to aimetti et al classification 2008 (ï‚£ 1mm thin;  1mm thick) in all maxillary incisors and/or mandibular incisors. Non.
  • •smokers. Periodontally and systemically healthy. Good oral hygiene.

排除标准

  • •Individual with insufficient platelet count(<200,000/cubic mm) Pregnant and lactating women Individuals undergoing orthodontic therapy Presence of restorations in selected teeth.

结局指标

主要结局

Gingival thickness

时间窗: At the day of procedure before injection(baseline) after 3 months and after 6 months

次要结局

  • Width of keratinized gingiva(At the day of procedure before injection(baseline) after 3 months and after 6 months)

研究者

发起方
Manasa Budhan
申办方类型
Other [self funding]

研究点 (1)

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