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临床试验/CTRI/2025/03/081551
CTRI/2025/03/081551尚未招募不适用

A comprehensive comparative evaluation of three aluminium chloride based gingival retraction systems : An In Vivo study

Dr Rashi Negi1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年3月14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
45
试验地点
1
主要终点
Vertical displacement (distance from CEJ to gingival margins in mm - sulcus depth) will be measured by three gingival retraction systems clinically.

研究概览

简要总结

This in vivo study will be conducted in Department of Prosthodontics, Uttaranchal Dental and Medical Research Institute, Dehradun. The aim of this study is to compare the efficacy of three Aluminium Chloride based gingival retraction systems: Retraction cord , Astringent gingival retraction paste and Retraction paste system with comprecap in patients.

The main objectives of this study are :-

  1. To compare the amount of lateral displacement and assess the changes in sulcus width by Retraction cord, Astringent gingival retraction paste and Retraction paste system with comprecap in patients.

  2. To compare the amount of vertical displacement and to analyize changes in sulcus depth by Retraction cord , Astringent gingival retraction paste and Retraction paste system with comprecapin patients by clinically measuring with a flexible strip.

  3. To compare the time taken for retraction by Retraction cord , Astringent gingival retraction paste and Retraction paste system with comprecap; the duration will be evaluated from the time of initiation of placement till the completion of placement.

  4. To compare the haemorrhage after retraction by Retraction cord , Astringent gingival retraction paste and Retraction paste system with comprecap on the basis of haemorrhage score.

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 and Outcome Assessor Blinded

入排标准

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

入选标准

  • Forty five patients whose age is more than eighteen years will be selected, requiring fixed prosthesis in maxillary or mandibular molars, the tooth can be vital or non-vital.
  • Clinically and radiographically healthy gingiva and periodontium around the abutment and abutment teeth should be of normal size and contour (no developmental anomaly or regressive age changes).

排除标准

  • Subjects with age less than eighteen years.
  • Gingival or periodontal disease.
  • Uncontrolled diabetes, hypertension, hyperthyroidism and other cardiovascular disorders.

结局指标

主要结局

Vertical displacement (distance from CEJ to gingival margins in mm - sulcus depth) will be measured by three gingival retraction systems clinically.

时间窗: After retraction the sulcus depth( vertical displacement) will be measured at baseline with approximate duration of 30 minutes and sulcus width( horizontal displacement) will be measured microscopically from the casts obtained by baseline impressions.

Lateral displacement of gingiva achieved by three systems microscopically from the cast obtained by the die stones at baseline impressions.

时间窗: After retraction the sulcus depth( vertical displacement) will be measured at baseline with approximate duration of 30 minutes and sulcus width( horizontal displacement) will be measured microscopically from the casts obtained by baseline impressions.

次要结局

  • The duration of time taken for placement of each retraction system can be evaluated by the time of initiation of placement till the time placement has been achieved. The duration of haemorrhage by each retraction system can be compared on the basis of haemorrhage score.(After retraction records will be measured at baseline with approximate duration of 30 minutes.)

研究者

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

Dr Rashi Negi

Uttaranchal Dental and Medical Research Institute

研究点 (1)

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