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Clinical Trials/CTRI/2025/03/081551
CTRI/2025/03/081551
Not yet recruiting
Not Applicable

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

Dr Rashi Negi1 site in 1 country45 target enrollmentStarted: March 14, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Dr Rashi Negi
Enrollment
45
Locations
1
Primary Endpoint
Vertical displacement (distance from CEJ to gingival margins in mm - sulcus depth) will be measured by three gingival retraction systems clinically.

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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).

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Time Frame: 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.

Secondary Outcomes

  • 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.)

Investigators

Sponsor
Dr Rashi Negi
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Rashi Negi

Uttaranchal Dental and Medical Research Institute

Study Sites (1)

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