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临床试验/CTRI/2024/05/067043
CTRI/2024/05/067043已完成3 期

Efficacy of injectable platelet rich fibrin in interdental papilla reconstruction as compared to connective tissue grafting

Dr Jeswin Johnson1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月23日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Change in interdental papilla height .

研究概览

简要总结

SUMMARY

Interdental papillae, which is a component of the gingivae, are found in the space between adjacent teeth. Open embrasures caused by interdental papillary loss can result in various issues, including aesthetic problems, phonetic difficulties, and food impaction. Injectable platelet-rich fibrin is an autologous platelet concentrate possessing higher amounts of growth factors that aid in regeneration. This study will assess whether black triangle width is reduced or papilla fill will be enhanced by the use of i-PRF as good as CTG. Minimally invasive approaches include nonsurgical procedures and those procedures that involve less trauma.  The procedure involves :

•Allocation of participants into test and control groups

•Connective tissue grafting will be done on control group and injectable PRF is injected into base of the papilla in test groups

•Measurements of Black triangle height , Papillary Height will be taken and reviewed at first and third month

•Clinical and photographic parameters will be re-recorded

•Data will be entered in MS Excel sheet and will be transferred to SPSS for analysis.

This study is conducted to evaluate efficacy of i-PRF compared to autogenous connective tissue graft (CTG), considered as gold standard, in interdental papilla reconstruction.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Otherwise systematically healthy individuals having at least one Nordland and Tarnows Class I or Class II open gingival or cervical embrasure in maxillary anterior region
  • FMBS and FMPS less than 20 percentage
  • Selected teeth must be free of restorations on the cervical (buccal or proximal) region
  • Radiographically, the distance between contact point (CP) to alveolar crest should be less than or equal to 6 mm
  • Minimal probing depth (less than or equal to 2 mm) adjacent to the open embrasure.

排除标准

  • Pregnant or lactating women
  • Previous periodontal surgery.
  • Undergoing active orthodontic treatment
  • Tooth mobility bruxism, missing or supernumerary teeth, mucogingival problem (shallow vestibule, aberrant frenemy attachment, or inadequate zone of attached gingiva) 6) Patients allergic to Ibuprofen.

结局指标

主要结局

Change in interdental papilla height .

时间窗: baseline (0) | After 1 month | After 3 months

次要结局

  • Change in black triangle(height)

研究者

发起方
Dr Jeswin Johnson
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Jeswin Johnson

Government dental college , Kottayam

研究点 (1)

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