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
|
|
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
|
|
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. |