| CTRI Number |
CTRI/2025/02/079851 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating Universal adhesives with three different adhesive strategies |
|
Scientific Title of Study
|
Evaluation of efficacy of various Universal Adhesives using three different adhesive strategies - 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 Geeta Asthana |
| Designation |
Head of the Department of Conservative Dentistry and Endodontics |
| Affiliation |
Government Dental College and Hospital, Ahmedabad |
| Address |
Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, New Civil Hospital Campus, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
7896996264 |
| Fax |
|
| Email |
geetasthana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashree Tamuli |
| Designation |
MDS STUDENT |
| Affiliation |
Government Dental College and Hospital, Ahmedabad |
| Address |
Room no. 9, Department of Consevarive Dentistry and Endodontics, Government Dental College and Hospital, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
07896996264 |
| Fax |
|
| Email |
rajashreetamuli98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajashree Tamuli |
| Designation |
MDS STUDENT |
| Affiliation |
Government Dental College and Hospital, Ahmedabad |
| Address |
Room no. 9, Department of Consevarive Dentistry and Endodontics, Government Dental College and Hospital, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
07896996264 |
| Fax |
|
| Email |
rajashreetamuli98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ahmedabad Dental Corporation, Basement of Shahibaug Hospital, Asarwa, Ahmedabad, Pin-380016, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Ahmedabad Dental Corporation |
| Address |
Basement of shahibaug hospital, Asarwa, Ahmedabad, Pin- 380016, Gujarat, India |
| Type of Sponsor |
Other [Dental material supplier] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Government Dental College Ahmedabad |
Asarwa Ahmedabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajashree Tamuli |
Government dental college and hospital ahmedabad |
Room no. 9, Department of Conservative Dentistry and Endodontics
Ahmadabad
GUJARAT |
7896996264
rajashreetamuli98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE GOVT. DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Class I cavity restoration |
Class 1 cavity restoration using Scotchbond Universal applied using three different adhesive strategies- etch and rinse, selective etch and self etch and evaluation after 6 months |
| Comparator Agent |
Class I cavity restoration |
Class I cavity restoration using Adhese Universal Bonding Agent using three different adhesive strategies and evaluation after 6 months |
| Comparator Agent |
Class I cavity restoration |
Class I cavity restoration using Prime and Bond Universal Adhesive using 3 different adhesive strategies and evaluation after 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age equal to or older than 18 years.
Class I carious lesions
Presence of at least three teeth (one for each adhesive protocol) to be restored per participant.
|
|
| ExclusionCriteria |
| Details |
Periodontitis
Teeth diagnosed with irreversible pulpitis
Users of braces or removable orthodontic appliances
Removable prosthesis wearers
Signs of parafunctional habits
Fluorosis in the enamel
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of clinical performance of three different universal adhesives used for restoration of class 1 cavities using three different adhesive strategies. Thee evaluation is done based on USPHS criteria by checking the restoration retention, marginal integrity, secondary caries formation, post-operative sensitivity, fracture or chipping of restoration |
baseline, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A holistic evaluation of the performance of universal adhesives, encompassing clinical, biological, & aesthetic aspects. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
12/02/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
•Dentin bonding agents play a strategic role in the sealing and retention of resin composite restorations. • Universal adhesives, also known as “multi-mode” or “multi-purpose” adhesives may be used as self-etch (SE) adhesives, etch-and-rinse (ER) adhesives, or as SE adhesives on dentin and ER adhesives on enamel (a technique commonly referred to as “selective enamel etching”) •The aim of this study is to evaluate clinical performances of various universal adhesives using etch and rinse, selective etch and self etch adhesive strategies. |