| CTRI Number |
CTRI/2026/01/101690 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical evaluation of non-carious cervical lesions with newer gic restorative materials 1 year follow up |
|
Scientific Title of Study
|
COMPARISON OF CLINICAL EVALUATION OF NEWER GIC RESTORATIVE MATERIALS IN NON-CARIOUS CERVICAL LESIONS:A RANDOMIZED CLINICAL STUDY - 1 YEAR FOLLOW UP |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DHARMANA JOSHNA |
| Designation |
Post Graduate Student |
| Affiliation |
Drs Sudha & Nageswara Rao Siddhartha Institute Of Dental Sciences |
| Address |
Drs Sudha & Nageswara Rao
Siddhartha Institute Of Dental Sciences
Department Of Conservative Dentistry and Endodontics
Room No 7
Gannavaram 521286
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
06305426033 |
| Fax |
|
| Email |
dharmanajoshna5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Janga Ravi Kumar |
| Designation |
Professor |
| Affiliation |
Drs Sudha & Nageswara Rao Siddhartha Institute Of Dental Sciences |
| Address |
Drs Sudha & Nageswara Rao
Siddhartha Institute Of Dental Sciences
Department Of Conservative Dentistry and Endodontics
Room No 7
Gannavaram 521286
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9440250244 |
| Fax |
|
| Email |
drkumarjanga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Janga Ravi Kumar |
| Designation |
Professor |
| Affiliation |
Drs Sudha & Nageswara Rao Siddhartha Institute Of Dental Sciences |
| Address |
Drs Sudha & Nageswara Rao
Siddhartha Institute Of Dental Sciences
Department Of Conservative Dentistry and Endodontics
Room No 7
Gannavaram 521286
ANDHRA PRADESH
521286
India |
| Phone |
9440250244 |
| Fax |
|
| Email |
drkumarjanga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dharmana Joshna Post graduate student Drs Sudha & Nageswara Rao
Siddhartha Institute Of Dental Sciences
Department Of Conservative Dentistry and Endodontics
Room No 7
Gannavaram 521286 |
|
|
Primary Sponsor
|
| Name |
DHARMANA JOSHNA |
| Address |
Drs Sudha & Nageswara Rao
Siddhartha Institute Of Dental Sciences
Department Of Conservative Dentistry and Endodontics
Room No 7
Gannavaram 521286 |
| 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 |
| DHARMANA JOSHNA |
Drs Sudha & Nageswara Rao Siddhartha Institute Of Dental Sciences |
Drs Sudha & Nageswara Rao
Siddhartha Institute Of Dental Sciences
Department Of Conservative Dentistry and Endodontics
Room No 7
Gannavaram 521286
Krishna
ANDHRA PRADESH |
06305426033
dharmanajoshna5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Drs Sudha & Nageswara Rao Siddhartha Institute Of Dental Sciences Institutional Ethical Commitee |
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 |
| Intervention |
BEAUTIFIL FLOW PLUS X |
GIOMER using with G PREMIO BOND bonding agent 1 year follow up |
| Comparator Agent |
EQUIA FORTE HT |
bulk fill glass hybrid restorative system 1 year study |
| Intervention |
RIVA LIGHT CURE |
light cured resin reinforced glass ionomer restorative material - 1year study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Good periodontal health, Patients with tooth sensitivity, Patients having aesthetic concerns, Low caries index, Wedge or saucer shaped lesions
|
|
| ExclusionCriteria |
| Details |
The Patient with systemic disease, Extreme poor oral hygiene, Mobile teeth
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| USPHS CRITERIA |
Baseline,6 months,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Retention, colour match, marginal discoloration ,secondary caries, wear, postoperative sensitivity |
6 months,12 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
19/02/2026 |
| 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="1"
Months="0"
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
|
comparison of clinical evaluation of newer gic restorative materials in non - carious cervical lesions a randomized clinical study - 1 year follow up |