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CTRI Number  CTRI/2024/11/076744 [Registered on: 13/11/2024] Trial Registered Prospectively
Last Modified On: 12/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry
Other (Specify) [retraction cord and astringent paste and gel and lasers]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Different Methods For Displacing Gums For Better Dental Impressions Using 3D Imaging 
Scientific Title of Study   "Comparative evaluation of gingival displacement produced by chemo-mechanical,chemical and surgical technique through digital scanning- A randomized controlled trial 
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 Madhurima Jain 
Designation  MDS Student of Conservative dentistry and Endodontics 
Affiliation  ITS CDSR GHAZIABAD 
Address  Department of Conservative dentistry and Endodontics ITS CDSR DELHI MEERUT Road Muradnagar , Ghaziabad, UP 201206 ITS-CDSR DELHI MEERUT Road Muradnagar,Ghaziabad,UP 201206 Ghaziabad 201206 India

Ghaziabad
UTTAR PRADESH
201206
India 
Phone  8859700660  
Fax    
Email  jain.madhurima33@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonali Taneja 
Designation  PROFESSOR, HOD,DEAN - PG STUDIES 
Affiliation  ITS CDSR GHAZIABAD 
Address  Department of conservative dentistry and endodontics ITS CDSR delhi meerut road muradnagar,ghaziabad,UP 201206

Ghaziabad
UTTAR PRADESH
201206
India 
Phone  9891688100  
Fax    
Email  sonalitaneja@its.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sonali Taneja 
Designation  PROFESSOR, HOD,DEAN - PG STUDIES 
Affiliation  ITS CDSR GHAZIABAD 
Address  Department of conservative dentistry and endodontics ITS CDSR delhi meerut road muradnagar,ghaziabad,UP 201206

Ghaziabad
UTTAR PRADESH
201206
India 
Phone  9891688100  
Fax    
Email  sonalitaneja@its.edu.in  
 
Source of Monetary or Material Support  
ITS Centre for Dental Studies, Muradnagar, Ghaziabad 201206 
 
Primary Sponsor  
Name  Dr. Madhurima Jain 
Address  ITS CDSR DELHI MEERUT Road Muradnagar, Ghaziabad, UP 201206 
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 
MADHURIMA JAIN  ITS centre for dental studies and research  Room No.6,PG Clinic,Department Of Conservative Dentistry And Endodontics Ghaziabad Uttar Pradesh 201206
Ghaziabad
UTTAR PRADESH 
8859700660

jain.madhurima33@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
I.T.S Institutional Ethics committee(IIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  chemomechanical,chemical,surgical agent  Comparison between different gingival displacement method used to retract gingiva 
Intervention  retraction cord,astringent paste gel,laser  The materials will be used to retract gingiva  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients requiring full coverage restorations in maxillary anterior teeth will be selected
No nsmokers or quit smoking before the study for at least 6 months
No malocclusion, with no crowding, rotation, or diastema in teeth in the anterior region 
 
ExclusionCriteria 
Details  signs of gingival or periodontal disease
Grossly decayed, tipped, tilted or rotated abutments
Medically compromised illnesses (diabetes, hyperthyroidism, hypertension and other cardiovascular disorders)
Pregnancy
Lactation
Alcohol-abusing
Specific drugs consumption 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate vertical displacement produced by cord, astringent paste, gel and laser after intra oral scan.  For retraction cord group- at baseline and after 8 minutes
For astringent paste group- at baseline and after 2 minutes
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate horizontal displacement produced by cord, astringent paste, gel & laser after intra oral scan.  For retraction group-at baseline & after 8 minutes
For astringent paste group-at baseline & after 2 minutes 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 3 
Date of First Enrollment (India)   25/11/2024 
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="0"
Months="6"
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 - NO
Brief Summary  
 
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