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CTRI Number  CTRI/2023/09/057754 [Registered on: 15/09/2023] Trial Registered Prospectively
Last Modified On: 31/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of 3 different gingival retraction agents 
Scientific Title of Study   A Comparative Evaluation of Different Gingival Retraction Methods – A Double Blinded 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 Unnati Agarwal  
Designation  PG student  
Affiliation  Sardar Patel Post graduate institute of dental and medical sciences  
Address  PG Section, Department Number 3, Department of Prosthodontics, Crown & Bridge, 1st floor, Sardar Patel Post graduate institute of dental and medical sciences, raebareli road, Lucknow

Lucknow
UTTAR PRADESH
226025
India 
Phone  9436832445  
Fax    
Email  unatiagarwal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhishek Singh 
Designation  Senior Lecturer 
Affiliation  Sardar Patel Post graduate institute of dental and medical sciences 
Address  PG Section, Department Number 3, Department of Prosthodontics, Crown & Bridge, 1st floor, Sardar Patel Post graduate institute of dental and medical sciences, raebareli road, Lucknow

Lucknow
UTTAR PRADESH
226025
India 
Phone  9918270131  
Fax    
Email  singhabhi0123@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhishek Singh 
Designation  Senior Lecturer 
Affiliation  Sardar Patel Post graduate institute of dental and medical sciences 
Address  PG Section, Department Number 3, Department of Prosthodontics, Crown & Bridge, 1st floor, Sardar Patel Post graduate institute of dental and medical sciences, raebareli road, Lucknow


UTTAR PRADESH
226025
India 
Phone  9918270131  
Fax    
Email  singhabhi0123@gmail.com  
 
Source of Monetary or Material Support  
room number 3, 1st floor, department of prosthodontics, crown & bridge, Sardar Patel Post graduate institute of dental and medical sciences, raebarelli road, lucknow, uttar pradesh, 226025 
 
Primary Sponsor  
Name  Dr Unnati Agarwal  
Address  PG section, Department number 3, 1st floor, Department of Prosthodontics, Crown & Bridge, Sardar Patel Post graduate institute of dental and medical sciences, raebareli road, Lucknow 
Type of Sponsor  Other [Self funded] 
 
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 Unnati Agarwal  sardar patel post graduate institute of dental and medical sciences  room number 3, 1st floor, department of prosthodontics, crown & bridge, Sardar Patel Post Graduate Institute of Dental & Medical Sciences Raibareli Road,Lucknow UTTAR PRADESH - 226025
Lucknow
UTTAR PRADESH 
9436832445

unatiagarwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Sardar Patel Post Graduate Institute of Dental and Medical Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  plain retraction cord  A control group of plain Retraction cord will be used in every patient of the study. Total number of patients will be 36 and retraction will be done just before impression  
Intervention  Retraction cord with epinephrine   The present study is therefore undertaken to identify the efficiency of retraction cord with epinephrine when compared with a control group with plain retraction cord. A total of 12 patients will be undertaken for this particular group and retraction will be done before impression  
Intervention  retraction gel  The present study is therefore undertaken to identify the efficiency of retraction gel when compared to the control group with plain retraction cord. A total of 12 patients will be undertaken for this particular group and retraction will be done before impression  
Intervention  retraction paste  The present study is therefore undertaken to identify the efficiency of retraction paste when compared with a control group with plain retraction cord. A total of 12 patients will be undertaken for this particular group and retraction will be done before impression  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  i. Patients willing for voluntary participation & have signed informed consent for the described procedure.
ii. Patients having good physical and mental health.
iii. Systemically healthy subjects.
iv. Patients requiring two individual single unit Fixed partial denture.
v. Patients well motivated for fixed partial denture.
vi. Patients well motivated for Porcelain fused Metal crown.
vii. Patients with healthy gingiva.
 
 
ExclusionCriteria 
Details  Partially edentulous patients
ii. Patients with implant site
iii. Patients with gingival recession
iv. Periodontally compromised tooth
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the amount of gingival retraction using retraction cord with epinephrine in single unit fixed partial dentures.
2. To evaluate the amount of gingival retraction using retraction paste in single unit fixed partial dentures.
3. To evaluate the amount of gingival retraction using retraction gel in single unit fixed partial dentures.
 
within 1 day of impression making 
 
Secondary Outcome  
Outcome  TimePoints 
To compare amount of gingival retraction using retraction cord with epinephrine, retraction paste and retraction cord in single unit fixed partial dentures.

 
2 months 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   23/09/2023 
Date of Study Completion (India) 15/11/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

The above study " A Comparative Evaluation of Different Gingival Retraction Methods – A Double Blinded In Vivo Study " is going to compare three different methods of gingival retraction using three different gingival retraction materials and their potential in gingival retraction when used in single unit fixed partial denture cases. It is going to be held over a period of 3 months. The study will be carried out on patients requiring two separate single unit fixed partial dentures attending the Out Patient Department of Prosthodontics and Crown & Bridge in Sardar Patel Post Graduate Institute of Dental and Medical Sciences. A written informed consent will be obtained from each patient after explaining the nature and outcome of procedure and the possible consequences and complications.

 Gingival retraction reversibly displaces the gingival tissues so that bulk of low viscosity impression material can be introduced in the widened sulcus and the margins can be captured. Gingival tissues are displaced both laterally and vertically. Lateral retraction displaces the tissues and provides adequate bulk of impression material so that it can be removed from the mouth intact with no tearing. Vertical retraction exposes the undercut portion of the tooth apical to the finish line.

The present study is therefore undertaken to identify the most efficient gingival retraction method out of Retraction Cord with Epinephrine, Retraction paste (3M) and Retraction Gel (Smart Retract) by measuring sulcus width and depth.

A control group of plain Retraction cord will be used in one single unit FPD and the retraction method to be compared will be used in another single unit FPD in the same patient, and the two groups will be compared.

 
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