FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/081551 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 28/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of three different gingival retraction systems with aluminium chloride 
Scientific Title of Study   A comprehensive comparative evaluation of three aluminium chloride based gingival retraction systems : An In Vivo study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rashi Negi 
Designation  Post graduate student 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Room no 3 , Department of Prosthodontics, Uttaranchal Dental and Medical Research Institute, Dehradun, Uttarakhand

Dehradun
UTTARANCHAL
248140
India 
Phone  6398423767  
Fax    
Email  negirashi1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shweta Gupta 
Designation  Head of the Department and Professor 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Room no. 3 , Department of Prosthodontics, Uttaranchal Dental and Medical Research Institute, Dehradun, Uttarakhand

Dehradun
UTTARANCHAL
248140
India 
Phone  9997206868  
Fax    
Email  drshwetagupta173@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rashi Negi 
Designation  Post graduate student 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Room no 3 , Department of Prosthodontics, Uttaranchal Dental and Medical Research Institute, Dehradun, Uttarakhand

Dehradun
UTTARANCHAL
248140
India 
Phone  6398423767  
Fax    
Email  negirashi1@gmail.com  
 
Source of Monetary or Material Support  
Room no. 3, Department of Prosthodontics, Uttaranchal Dental and Medical Research Institute, Mazri grant, Dehradun,Uttarakhand, India, 248140 
 
Primary Sponsor  
Name  Dr Rashi Negi 
Address  Room no 3, Department of Prosthodontics, Uttaranchal Dental and Medical Research Institute, Dehradun , Uttarakhand, 248140 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rashi Negi  Uttaranchal Dental and Medical Research institute  Room no 3 , Department of Prosthodontics, Uttaranchal Dental and Medical Research Institute, Dehradun, Uttarakhand
Dehradun
UTTARANCHAL 		 6398423767

negirashi1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, UDMRI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Retraction cord   Retraction cord with reinforced fine metal filament as well as aluminium chloride will be used before impression. A total of 45 patients will be taken for this study , out of which 15 patients will undergo retraction with Stay-put retraction cord. When the Stay-put is shaped, it remains in its shape due to its unique combination of ultra fine copper filament and softly braided retraction cord, it becomes very easy to place in the sulcus. After preparation of tooth, the Stay-put retraction cord will be inserted into the sulcus for at least 5 minutes and then will be removed after proper retraction is achieved before making the final impression. Due to impregnation with aluminium chloride promotes quick haemostasis.  
Intervention  Retraction paste system   Astringent Retraction Paste contains 15% aluminium chloride. It is easily dispensed right into the sulcus, gently retracts tissue and controls bleeding. Cordless gingival retraction technique, 3M astringent retraction paste gingival retraction shall be done on 15 patients. The retraction capsule will be inserted into a dispenser with some amount of paste extruded and discarded. The tip of the capsule inserted into the sulcus with gradual flow of retraction paste into the sulcus until complete filling for a minimum duration of 2 minutes. After retraction the astringent retraction paste is removed by air-water syringe and suction. It is an easy retraction system with minimal risk of bleeding as well as less time consuming. The extra-fine tip of the capsule helps in direct flow of paste into the sulcus.  
Intervention  Retraction paste system with comprecap   A total of 15 patients will be undertaken for this particular group of haemostatic retraction paste system along with Comprecap. It contains 15% aluminium chloride which produces gentle pressure on the sulcus while it absorbs excess crevicular fluid and blood. Comprecap are anatomic formed cotton caps that work synergistically with paste to quicken and assist retraction and haemostasis. The haemostatic retraction paste - Premier Dental Traxodent syringe has sleek design along with bendable tip facilitates easy application directly into the sulcus after preparation of tooth. While retraction procedure, Comprecap will be used to guide Traxodent’s soft paste into sulcus for maximum tissue deflection, thereby providing a convenient and effective means to manage bleeding and crevicular seepage before the impression. The retraction paste should be placed for a minimum duration of 2 minutes as the time frame enables paste to achieve haemostatis and tissue retraction. After retraction the Comprecap will be removed and retraction paste will be removed by air-water syringe and suction before final impression.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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). 
 
ExclusionCriteria 
Details  Subjects with age less than eighteen years.
Gingival or periodontal disease.
Uncontrolled diabetes, hypertension, hyperthyroidism and other cardiovascular disorders. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Vertical displacement (distance from CEJ to gingival margins in mm - sulcus depth) will be measured by three gingival retraction systems clinically.
Lateral displacement of gingiva achieved by three systems microscopically from the cast obtained by the die stones at baseline impressions. 		 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 Outcome  
Outcome  TimePoints 
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. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [negirashi1@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
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.
 
Close