跳至主要内容
临床试验/CTRI/2017/01/007719
CTRI/2017/01/007719已完成不适用

Comparative evaluation of the efficacy of a commercially available collagen dressing (Collacote®) with autologous Platelet Rich Fibrin (PRF) membrane on the wound healing of palatal donor site of free gingival graft

Institute of Dental Studies and Technologies1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年5月5日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Immediate Bleeding

研究概览

简要总结

This study was conducted and compiled by Dr.Varsha Sharma, Dr.Ashish Kumar, Dr.Komal Puri, Dr.Mansi Bansal and Dr.Manish Khatri at Department Of Periodontology, Institute of Dental Studies and Technologies, Kadrabad, Modinagar, Uttar Pradesh, India

The study is a randomized control trial for comparison of the effect of commercially available collagen dressing (colla cote®) and autologous platelet rich fibrin on the wound healing of palatal donor site of free gingival graft.  Assessment and comparison of various wound healing parameters, time required for complete epithelization of wound and considerable morbidity during the healing period was done.

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 Blinded

入排标准

年龄范围
18.00 Year(s) 至 52.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy patients aged 18 years or more, 2)Patient not under any medication for the past six months, 3)Patients requiring FGG either for reduced/ inadequate gingiva or gingival recession in the maxillary or mandibular anterior region, 4)Patients who have not undergone any palatal graft procedure in the past one year.

排除标准

  • Smokers, 2)Pregnant or lactating mothers, 3)Patients not maintaining oral hygiene.

结局指标

主要结局

Immediate Bleeding

时间窗: Immediate Bleeding:After suturing the donor area | Delayed Bleeding: Between 1st – 7th Post operative days | Pain Score, size, Toluidine blue test: 7th ,12th, 18th, 24th and 30th post-operative day. | Depth of wound: Before surgery, immediately post surgery, post application of dressing and on 12th, 24th and 30th post-operative days. | Hydrogen peroxide test for epithelialization: 7th & 8th, 12th &13th, 18th &19th, 24th &25th, 30th & 31st post-operative day.

Delayed Bleeding

时间窗: Immediate Bleeding:After suturing the donor area | Delayed Bleeding: Between 1st – 7th Post operative days | Pain Score, size, Toluidine blue test: 7th ,12th, 18th, 24th and 30th post-operative day. | Depth of wound: Before surgery, immediately post surgery, post application of dressing and on 12th, 24th and 30th post-operative days. | Hydrogen peroxide test for epithelialization: 7th & 8th, 12th &13th, 18th &19th, 24th &25th, 30th & 31st post-operative day.

Pain Score

时间窗: Immediate Bleeding:After suturing the donor area | Delayed Bleeding: Between 1st – 7th Post operative days | Pain Score, size, Toluidine blue test: 7th ,12th, 18th, 24th and 30th post-operative day. | Depth of wound: Before surgery, immediately post surgery, post application of dressing and on 12th, 24th and 30th post-operative days. | Hydrogen peroxide test for epithelialization: 7th & 8th, 12th &13th, 18th &19th, 24th &25th, 30th & 31st post-operative day.

Size of wound

时间窗: Immediate Bleeding:After suturing the donor area | Delayed Bleeding: Between 1st – 7th Post operative days | Pain Score, size, Toluidine blue test: 7th ,12th, 18th, 24th and 30th post-operative day. | Depth of wound: Before surgery, immediately post surgery, post application of dressing and on 12th, 24th and 30th post-operative days. | Hydrogen peroxide test for epithelialization: 7th & 8th, 12th &13th, 18th &19th, 24th &25th, 30th & 31st post-operative day.

Depth of wound

时间窗: Immediate Bleeding:After suturing the donor area | Delayed Bleeding: Between 1st – 7th Post operative days | Pain Score, size, Toluidine blue test: 7th ,12th, 18th, 24th and 30th post-operative day. | Depth of wound: Before surgery, immediately post surgery, post application of dressing and on 12th, 24th and 30th post-operative days. | Hydrogen peroxide test for epithelialization: 7th & 8th, 12th &13th, 18th &19th, 24th &25th, 30th & 31st post-operative day.

Toluidine blue test for epithelization

时间窗: Immediate Bleeding:After suturing the donor area | Delayed Bleeding: Between 1st – 7th Post operative days | Pain Score, size, Toluidine blue test: 7th ,12th, 18th, 24th and 30th post-operative day. | Depth of wound: Before surgery, immediately post surgery, post application of dressing and on 12th, 24th and 30th post-operative days. | Hydrogen peroxide test for epithelialization: 7th & 8th, 12th &13th, 18th &19th, 24th &25th, 30th & 31st post-operative day.

Hydrogen peroxide test for epithelization

时间窗: Immediate Bleeding:After suturing the donor area | Delayed Bleeding: Between 1st – 7th Post operative days | Pain Score, size, Toluidine blue test: 7th ,12th, 18th, 24th and 30th post-operative day. | Depth of wound: Before surgery, immediately post surgery, post application of dressing and on 12th, 24th and 30th post-operative days. | Hydrogen peroxide test for epithelialization: 7th & 8th, 12th &13th, 18th &19th, 24th &25th, 30th & 31st post-operative day.

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital

研究点 (1)

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