跳至主要内容
临床试验/CTRI/2021/01/030846
CTRI/2021/01/030846尚未招募不适用

Comparative evaluation of pinhole surgical technique with and without A-PRF in the treatment of multiple adjacent recession defects in maxillary anterior region – A Randomized Controlled Trial

Divya Suresh Trivedi1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2021年1月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
23
试验地点
1
主要终点
Improvement in Mean Root coverage at baseline 3 months and 6 months in both groups

研究概览

简要总结

Study will be conducted to evaluate efficacy of pinhole surgical technique along with A-PRF over pinhole surgical technique alone in treatment of bilateral multiple adjacent gingival recession defects (millers class I/ II gingival recession defects) patients, clinically A total of 23 participants  affected with bilateral multiple adjacent gingival recession defects including both male and female visiting the Department of Periodontics at VSPM Dental College and research centre Nagpur will be recruited for this study

In each patient two sites will be randomly assigned as

Group I( 23 patients- Control sites)– Class I/ II gingival recession defects treated with Pinhole Surgical Technique alone

Group II(23 patients- Test sites)– Class I/ II gingival recession defects treated with Pinhole Surgical Technique with A-PRF

 The primary outcome will be improvement in Mean root coverage at baseline 3 months and 6 months in both groups

The secondary outcome will be the Improvement in Width of keratinized gingiva (WKG) Probing Pocket depth (PPD) Clinical attachment level (CAL) Recession depth (RD) in gingival recession defects treated with Pinhole surgical technique alone and in combination with A-PRF at baseline 3 and 6 months clinically and radiographically with the help of CBCT postoperatively

A brief description of entire procedure will be given to every patient before starting procedure. Written informed consent will be taken from the patients who wish to enrol in the study

For all participants following periodontal parameters will be recorded

1 Full mouth plaque score (FMPS)

2 Full mouth bleeding score (FMBS)

3 Probing pocket depth (PPD)

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1Systemically healthy patients 2Patient with healthy and stable soft tissue architecture 3Co-operative, motivated and hygiene conscious patients 4Patients exhibiting bilateral Millers Class I or II multiple adjacent gingival recession defects 5Patients with ≥1mm of attached gingiva at gingival recession sites.

排除标准

  • 1Pregnant or lactating females 2Tobacco smokers 3Uncontrolled medical conditions precluding elective surgery 4 Untreated periodontal conditions 5Patients treated with any medication known to cause gingival hyperplasia 6 Drug and alcohol abuse 7 In addition, non-vital teeth, carious teeth warranting restorations and mobility > grade II will also be excluded.

结局指标

主要结局

Improvement in Mean Root coverage at baseline 3 months and 6 months in both groups

时间窗: baseline 3 months 6 months

次要结局

  • Improvement in Width of keratinized gingiva (WKG), Probing Pocket depth (PPD) Clinical attachment level (CAL) Recession depth (RD) in gingival recession defects treated with Pinhole surgical technique alone and in combination with A-PRF at baseline 3 and 6 months postoperatively(baseline 3 month 6 month)

研究者

发起方
Divya Suresh Trivedi
申办方类型
Other [self]

研究点 (1)

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