跳至主要内容
临床试验/CTRI/2025/09/094751
CTRI/2025/09/094751已完成4 期

Comparative Evaluation of Injectable Platelet Rich Fibrin and Placental Extract in the Management of Gingival Black Triangles.

Moturi Padmini Raj1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年10月1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
28
试验地点
1
主要终点
Interdental papillary height

研究概览

简要总结

This study is a
randomized, parallel group clinical trial comparing the efficacy of the
placental extract and i-PRF for the management of deficient interdental
papilla. Interdental papillary deficiency creates open gingival embrasures,
also called “black triangles” which
compromises
esthetics, increases the retention of food debris and causes phonetic problems. Various surgical and non-surgical
approaches have been put forth for the management of the black triangles

Placenta is enriched with mesenchymal cells which have the capacity to differentiate into different types of cells. It promotes fibrogenesis, neo angiogenesis and epithelialization thus boosting the wound healing. It also has anti-inflammatory, antimicrobial, immune stimulating, anti-platelet aggregation properties.

Injectable platelet-rich fibrin (i PRF), is a second-generation autologous platelet concentrate. It promotes tissue regeneration, wound healing, improves angiogenesis and has an anti-inflammatory and anti-microbial property.

All the patients will receive phase I therapy which include supragingival and subgingival scaling and root planning. Patients will be recalled after one-week and clinical parameters such as Papillary Bleeding Index and Interdental Papillary Height will be recorded before the procedure. Pre operative photographs will be taken and ImageJ software program will be used to measure BTH, BTW and BTA. After administration of a local anaesthesia 2% lignocaine containing adrenaline 1:80,000. The needle will be inserted at a 45o angle in an area 2 to 3 mm below the interdental papilla tip.

Group A :0.2 mL of a placental extract (Placentrex®) Group B: 0.2 mL of i-PRF. Patient will be recalled after 1 and 3 months for recording clinical parameters. Post-operative photographs will be taken to measure BTH, BTW and BTA.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Individuals with age group of 20-45 years of either gender.
  • Patients with PPI 2 interdental papillary loss with no radiographic evidence of bone loss in maxillary anterior tooth region.
  • Respective teeth are free from caries with no fixed prosthesis or orthodontic appliance.

排除标准

  • Patients with systemic disease
  • Pregnant and lactating women.
  • Any forms of tobacco users.
  • Patients consuming drugs causing gingival hyperplasia.
  • Patient who had undergone periodontal plastic surgery for the selected area in the last 1 year.
  • Adjacent teeth with caries, fixed prosthesis, or orthodontic appliance.

结局指标

主要结局

Interdental papillary height

时间窗: baseline,1 and 3 months

次要结局

  • •Papillary Bleeding Index (PBI)

研究者

发起方
Moturi Padmini Raj
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Moturi Padmini Raj

Sibar Institute of Dental Sciences

研究点 (1)

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