| CTRI Number |
CTRI/2025/08/092803 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison between resin modified glass ionomer cement and universal injectable composite in non carious cervical lesions |
|
Scientific Title of Study
|
Comparative clinical evaluation of resin modified glass ionomer cement and universal injectable composite in non-carious cervical
lesions: a prospective randomised clinical 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 Akshay Punjabi |
| Designation |
PG student |
| Affiliation |
Bharti vidyapeeth dental college and hospital, Navi mumbai |
| Address |
Room no 302, 3rd floor, Department of conservative dentistry and endodontics, Bharti vidyapeeth dental college and hospital, Sector 7 CBD belapur, Navi mumbai
Mumbai
MAHARASHTRA
400614
India |
| Phone |
08329015699 |
| Fax |
|
| Email |
akshaypunjabi94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Rao |
| Designation |
Professor |
| Affiliation |
Bharti vidyapeeth dental college and hospital, Navi mumbai |
| Address |
Department of Conservative Dentistry and Endodontics, Bharti Vidyapeeth Deemed to be University Dental College & Hospital, Navi Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400614
India |
| Phone |
09820094178 |
| Fax |
|
| Email |
drrahulrao25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Rao |
| Designation |
Professor |
| Affiliation |
Bharti vidyapeeth dental college and hospital, Navi mumbai |
| Address |
Department of Conservative Dentistry and Endodontics, Bharti Vidyapeeth Deemed to be University Dental College & Hospital, Navi Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400614
India |
| Phone |
09820094178 |
| Fax |
|
| Email |
drrahulrao25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharti vidyapeeth dental college and hospital, Navi mumbai 400614 |
|
|
Primary Sponsor
|
| Name |
Dr Akshay Punjabi |
| Address |
Room no 302, 3rd floor, Department of conservative dentistry and endodontics, Bharti vidyapeeth dental college and hospital, Sector 7 CBD belapur, Navi mumbai |
| Type of Sponsor |
Other [Self] |
|
|
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 Akshay Punjabi |
Bharati Vidyapeeth Dental College and Hospital |
Room no 302, 3rd floor, Department of conservative dentistry and endodontics
Mumbai
MAHARASHTRA |
9820166143
akshaypunjabi94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for biomedical and health research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non carious cervical lesions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Resin modified glass ionomer cement |
Resin modified glass ionomer cement is considered as gold standard for restoration of non carious cervical lesions due to its excellent retentive properties |
| Intervention |
Universal injectable composite |
Universal injectable composite material is the new material came into the market. Has excellent esthetics, good flexural strength and properties to be used in restoration of non carious cervical lesions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Co-operative healthy subjects willing to participate in the study and sign the consent
form.
Subjects having a minimum of 2 such noncarious cervical lesions in their mouth.
Subjects having noncarious cervical lesions involving enamel and dentin.
Subjects having good oral hygiene.
Subjects aged 18 years and above of either gender.
Subjects should have at least 20 permanent teeth. |
|
| ExclusionCriteria |
| Details |
Subjects unwilling to sign the consent form.
Previously restored or fractured teeth.
Medically compromised, mentally challenged adults.
History of existing tooth sensitivity.
Known allergy to resin based materials.
Bruxism.
Pregnancy or breast feeding subject.
Subjects with restricted mouth opening.
Chronic use of anti-inflammatory, analgesics and psychotropic drugs. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical performance |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
26/08/2025 |
| 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="4"
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
|
Non carious cervical lesions are difficult to restore due to their position and presence of sclerotic dentin. Numerous materials were tried for restoration of non carious cervical lesions. In all of them, Resin modified glass ionomer cement was considered the gold standard in restoring non carious cervical lesions. Recently, universal injectable composite came into market for same purpose. Therefore, aim of our study is to clinically compare these two materials for restoration of non carious cervical lesions |