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临床试验/CTRI/2022/04/042092
CTRI/2022/04/042092尚未招募3 期

Evaluation of the effectiveness of adjunctive intra pocket delivery of injectable platelet concentrate (iPRF) in non surgical periodontal therapy-A randomized controlled split mouth trial

State Board Of Medical Research1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年2月5日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Probing pocket depth

研究概览

简要总结

Periodontal disease is the sixth most prevalent health condition that affects humans. It is one of the important reasons for tooth loss, impacts the quality of life of individuals. Emerging evidence links it to several systemic life threatening conditions like cardiovascular disease and diabetes making it an important public health problem. The objective of the prospective intervention trial is to assess the effectiveness of intrapocket delivery of injectable platelet rich fibrin in the non surgical management of moderate to severe periodontitis when compared to conventional scaling root planing. These autologous platelet concentrate are suspensions of growth factors and when applied locally ,they can induce soft and hard tissue regeneration. Since the standard PRF is not entirely appropriate for injection ,a new injectable formulation of PRF(termed i-PRF)enables easier use of platelet concentrate in liquid state. Otherwise healthy adults with moderate to severe periodontitis who satisfies the inclusion criteria are included in the study.Eligible individuals are randomized into test and control groups by split mouth design. Conclusions will be drawn based on the results. Treatment of periodontal disease is complicated and expensive. Many patients require invasive procedures including regenerative therapy. Adjunctive approaches to conventional non surgical therapy has page  been investigated widely to avoid invasive surgical interventions. This study is such an attempt, where by an  adjuvant like autologous platelet concentrate is added to conventional nonsurgical therapy in order to assess whether there is any improvement in clinical outcomes when compared to non surgical therapy alone. If found beneficial it would be highly encouraging for the resource poor Indian health system.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
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

  • (a) subjects with age more than 18 (b) systemically healthy subjects (c) Patients with at least two sites with probing pocket depth (PPD) ≥ 5 mm on contralateral side either in maxilla or mandible.

排除标准

  • Subjects with habit of Smoking and tobacco chewing 3) Subjects taking Medications affecting the periodontium 4) Pregnancy or lactation 5) Subjects received probiotic or antimicrobial therapy in the past 6 months 6) Subjects underwent periodontal therapy in the past 6 months.

结局指标

主要结局

Probing pocket depth

时间窗: Final outcome assessed at 6th month after nonsurgical periodontal therapy

次要结局

  • 1) clinical attatchment level(2) Gingival recession)

研究者

发起方
State Board Of Medical Research
申办方类型
Government medical college

研究点 (1)

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