| CTRI Number |
CTRI/2026/02/104727 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to find out the Performance of a Tooth-Colored Filling Material in Adults with Worn Teeth Over 18 Months |
|
Scientific Title of Study
|
Clinical Evaluation of Resin Modified Glass Ionomer Cement in management of Cervical abrasive Teeth – A 18-month prospective 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 |
LR Ranjith Jeba John |
| Designation |
Postgraduate student |
| Affiliation |
CSI college of dental sciences and research |
| Address |
Room No 6,CSI College of Dental Sciences and Research ,
Department of Conservative Dentistry and Endodontics,129 CMH
Compound ,East Veli Street
Madurai
TAMIL NADU
625001
India |
| Phone |
8056371289 |
| Fax |
|
| Email |
ranjithjebajohn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and Professor of conservative dentistry and endodontics |
| Affiliation |
CSI college of dental sciences and research |
| Address |
Room No 6,CSI College of Dental Sciences and Research ,
Department of Conservative Dentistry and Endodontics,129 CMH
Compound ,East Veli Street
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and Professor of conservative dentistry and endodontics |
| Affiliation |
CSI college of dental sciences and research |
| Address |
Room No 6,CSI College of Dental Sciences and Research ,
Department of Conservative Dentistry and Endodontics,129 CMH
Compound ,East Veli Street
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
L.R. Ranjith Jeba John |
| Address |
Room no 6 , Department of operative dentistry and endodontics ,CSI
College of dental sciences and research , 129 CMH Compound ,East
Veli Street ,Madurai 625001
|
| 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 LR Ranjith Jeba John |
CSI College of dental sciences and research |
Room No 6,CSI College
of Dental Sciences and
Research , Department
of Conservative
Dentistry and
Endodontics,129 CMH
Compound ,East Veli
Street,
Madurai
TAMIL NADU |
8056371289
ranjithjebajohn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee and Institutional Review Board CSI college of Dental Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K031||Abrasion of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Resin modified Glass ionomer cement |
LOCAL DRUG DELIVERY
CONDITIONER:GC Dentin Conditioner, GC India Dental Pvt Ltd, Telangana, India
GC Dentin Conditioner applied using with microbrush or cotton pellet.
Leave for 10–20 seconds.
Gently rinsed with water to remove conditioner residues.
Dentin blot dried and slightly moist.
RESIN MODIFIED GLASS IONOMER CEMENT: GC Gold Label 2 Lc (Light-Cured)
GC India Dental Pvt Ltd, Telangana, India
The standard powder to liquid ratio is 3.2g / 1.0g. 1 level scoop of powder to 2 drops of liquid
mixing time 20 - 25 seconds
working time 45 seconds
Light cured for 20 seconds using a visible light curing device (470 nm wavelength) placed as closely as possible
The total duration of such intervention ranges from 10 - 15 minutes per tooth |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 20 and 70 years with teeth responding immediately and positively to cold stimulus (Endo Frost, Coltene-Whaledent, Switzerland)
Patients with at least one tooth having NCCL with complaints of sensitivity to cold and/or air blast to level of 1 in SCASS
Periapical radiographs revealing no evidence of periapical changes
Lesion depth has to be a minimum of 1 mm with exposed dentin
Patients with good oral hygiene and no periodontal disease
|
|
| ExclusionCriteria |
| Details |
Tooth with signs or symptoms of irreversible pulpitis or necrotic pulp. Cervical lesions with pulp exposure evident
Patients not able to localize the cervical dentin hypersensitivity to any particular tooth
Lesions extending subgingivally and requiring gingival tissue removal
Patients who had previous restorations of the concerned teeth or had treatment for cervical dentin hypersensitivity
Teeth periodontally compromised
Patients with any uncontrolled medical conditions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the marginal integrity, surface texture, gingival health, postoperative sensitivity, and retention following RMGIC restoration in teeth with cervical abrasion |
3 months, 6 months, 9 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the tooth survival following RMGIC restoration |
3 months, 6 months, 9 months, 12 months, 18 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/03/2026 |
| 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="6"
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
|
This 18-month prospective clinical study evaluates the effectiveness of Resin Modified Glass Ionomer Cement (RMGIC) in the management of 200 anterior and posterior teeth with cervical abrasion.The study aims to assess marginal integrity, surface texture, marginal discoloration, gingival health, postoperative sensitivity, and retention of restorations over the follow-up period. The findings are intended to determine the clinical performance and longevity of RMGIC in managing cervical abrasive lesions |