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CTRI Number  CTRI/2026/02/102802 [Registered on: 02/02/2026] Trial Registered Prospectively
Last Modified On: 01/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   a clinical study to compare two tooth-colored restorative materials (resin modified glass ionomer cement and light-cured glass ionomer cement) used for treating cervical tooth lesions 
Scientific Title of Study   Clinical evaluation of Light cured Glass Ionomer cement versus Resin-modified Glass Ionomer Cement in class V carious and non-carious lesions: A Randomized Comparative 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  Anusha Saxena 
Designation  post graduate 
Affiliation   
Address  mahatma Gandhi dental college, jaipur
room 5, department of conservative dentistry and endodontics
Jaipur
RAJASTHAN
302022
India 
Phone  09694580586  
Fax    
Email  anusha.saxena0550@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anusha Saxena 
Designation  post graduate 
Affiliation   
Address  department of conservative dentistry and endodontics
room no. 5
Jaipur
RAJASTHAN
302022
India 
Phone  09694580586  
Fax    
Email  anusha.saxena0550@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anusha Saxena 
Designation  post graduate 
Affiliation   
Address  mahatma Gandhi dental college, jaipur
department of conservative dentistry ad endodontics, room 5, dental division
Jaipur
RAJASTHAN
302022
India 
Phone  09694580586  
Fax    
Email  anusha.saxena0550@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  mahatma Gandhi dental college jaipur 
Address  Mahatma Gandhi Dental college, RIICO industrial area, sitapura , jaipur, India pincoe- 302022 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anusha Saxena  Mahatma Gandhi Dental College  Mahatma Gandhi dental college, room 5. department of conservative and endodontics , dental division, ricco industrial area, sitapura, jaipur
Jaipur
RAJASTHAN 
01412771777

info@mgumst.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC for biomedical and health research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  class V carious and non-carious lesions of teeth 
Patients  (1) ICD-10 Condition: K026||Dental caries on smooth surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  light cured GIC  new GIC added to study for comparison of results for 6 and 12 months  
Comparator Agent  resin modified GIC   type of GIC restored once and follow up for 6 and 12 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Class V lesions- carious or non-carious lesions
Age group 18 to 40 years
Pre-operative sensitivity scores of 2 or 3
 
 
ExclusionCriteria 
Details  Periodontally compromised
Pulpal inflammation
Presence of periapical radiolucency
Patients allergic to resin material
Habits of clenching and bruxism
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical Performance Using USPHS criteria ad post operative sensitivity  at 6 and 12 months intervel 
 
Secondary Outcome  
Outcome  TimePoints 
root canal treatment  12 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 2 
Date of First Enrollment (India)   12/02/2026 
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)   Open to Recruitment 
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  
For this study 50 patients with class V carious and non-carious lesion will be selected.
Fifty participants with class V carious and non-carious lesions will randomly be assigned to two
groups based on the restorative material used. The intervention group (Group 1) will receive light
cured GIC, and the control group (Group 2) will receive RMGIC.
The clinical performance will be assessed at baseline, after 6 and 12 months follow-up using the
modified United States Public Health Service (USPHS) criteria.
Recruited participants will be provided with comprehensive details about the study, after which they
will sign an informed consent .History taking, caries risk assessment, and dental examination will be
done. Prophylactic scaling and polishing will be carried out for all eligible participants. Any dental
concerns were addressed before the start of the trial.
A conservative cavity design will be prepared using round shaped carbide burs with sharp dental
excavators to remove soft carious dentin. The prepared cavity was finished using yellow-coded,
extra-fine, and diamond finishing burs.
GROUP -1 (Light Cured Glass Ionomer Cement)
Selective enamel etching, thorough rinsing, and gentle air dryness were performed (OptiBond Gel
Etchant, Kerr Corporation, California, USA) followed by adhesive application. Light cured GIC (3M
Ketac N100 light-curing glass ionomer restorative) will be applied incrementally 2 mm into the
prepared cavity and sculpted using gold plated applicators. Each increment was light cured for 10 s.
using LED light curing unit (iLED plus, Guilin Woodpecker Medical Instrument Co. Ltd., Guangxi,
China).
GROUP -2 (Resin-Modified Glass Ionomer Cement)
Dentin conditioning was done using 10% polyacrylic acid for 20 s (Dentin Conditioner, GC
Corporation, Tokyo, Japan) followed by thorough rinsing and gentle air dryness. The was done with
resin modified gic (GC Fuji plus RM GIC, Tokyo, Japan) and mixed for 10 s, extruded into the
prepared cavity incrementally 2 mm using the capsule applier, sculpted using a gold plated applicator
Finishing and polishing.
For both groups, yellow-coded, extra-fine diamond finishing stones will be used for restoration
contouring and finishing followed by polishing using silicone cups and points till a smooth, lustrous
surface will be obtained. For the control group, a resin coat (Fuji coat LC, GC Corporation, Tokyo,
Japan) will applied on the restoration surface, and then light cured for 20 s.
After the restoration is done ,it will be evaluated for marginal adaptaion, marginal staining, surface
texture, secondary caries, retention and post operative sensitivity.
The marginal staining will be evaluated using 2% Methylene blue dye[4] at 6 months and 12 months
interval.
The dye penetration is checked at tooth-restoration interface under 6x magnification using
microscope.
The subjects’ responses will be evaluated by Schiff analog scale to assess postoperative sensitivity to
an air blast stimulus. It assigns scores ranging from 0 to 3 to participants. The scoring criteria for the
Schiff analog scale are the following:
Patients exhibiting pre-operative scores of 2 or 3 on the Schiff scale will be also incorporated into this
research.
Marginal Staining- The marginal staining will be evaluated using 2% Methylene blue dye.
The dye penetration is checked at tooth-restoration interface under 6x magnification using microscope.
Marginal Adaptation- Using DG-16 explorer.
The explorer gently moved along the crevice to check for marginal adaptation.
Surface Texture-
1. Polished=0 using DG-16 explorer
2. Gritty=1
3. Course=2
Secondary Caries- Secondary caries will be evaluated using IOPA radiographs.
retention present or absent
 
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