| CTRI Number |
CTRI/2025/01/079473 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
06/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation Of Performance Of Resin Modified Glass Ionomer Cement and other Composites in Non-carious Cervical Lesions.
|
|
Scientific Title of Study
|
Assessment of clinical performance of resin modified Glass lonomer Cement, nanohyhrid
and nanofillcd single shade composites in non-carious cervical lesions using a modified USPHS
criteria - A Randomised Controlled 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 |
URJA PIRAJI MALI |
| Designation |
PG STUDENT |
| Affiliation |
|
| Address |
311, Department of Conservative Dentistry and Endodontics, VSPM dental college, Hingna, Nagpur
VSPM dental college, Higna, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
|
| Fax |
|
| Email |
urjamali18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MOHIT GUNWAL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
|
| Address |
311, Department of Conservative Dentistry and Endodontics, VSPM dental college, Hingna, Nagpur
311, Conservative Dentistry and Endodontics, VSPM dental college, Hingna, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9175027155 |
| Fax |
|
| Email |
dr.mohitgunwal@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
MOHIT GUNWAL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
|
| Address |
311, Department of Conservative Dentistry and Endodontics, VSPM dental college, Hingna, Nagpur
311, Conservative Dentistry and Endodontics, VSPM dental college, Hingna, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9175027155 |
| Fax |
|
| Email |
dr.mohitgunwal@yahoo.in |
|
|
Source of Monetary or Material Support
|
| 311, Conservative Dentistry and Endodontics, VSPM dental college, Hingna, Nagpur, Maharashtra, India 440019 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Urja Mali |
VSPM Dental college |
311, Conservative Dentistry and Endodontics, VSPM dental college, Hingna, Nagpur, Hingna, Nagpur
Nagpur
MAHARASHTRA |
7710978347
urjamali18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
RMGIC |
IN NCCLS |
| Intervention |
SINGLE SHADE COMPOSITE |
IN NCCLS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
A )Patient Related
1. Aged 18 to 65 will be included in the study (13)
2. Both male and female
3. Right handed patients
4. Good oral hygiene & Patients with healthy periodontal status (Oral Hygiene Index-Simplified) (23)
5. Low caries index (DMFT index of less than 12)
B) Teeth Related
1. Mandibular 1st premolar with hypersensitivity evaluated by air blast test
2. Left side vital teeth - evaluated by electric pulp testing
3. Supragingival wedge or saucer shaped lesions
|
|
| ExclusionCriteria |
| Details |
1. Caries involving the cervical area
2. Restorations near the teeth to be restored
3. Crack teeth
4. Habits such as tobacco chewing, pan , alcohol, smoking etc
5. Advanced periodontitis
6. Patients undergoing orthodontic treatment or having prosthesis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SINGLE SHADE COMPOSITES ARE MORE EFFICIENT THAN RESIN MODIFIED GIC |
24hrs, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NANOHYBRID SINGLE SHADE COMPOSITE IS MORE EFFICIENT THAN NANOFILLED |
6 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
|
Phase 4 |
|
Date of First Enrollment (India)
|
04/02/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Patients
with non-carious cervical lesions fulfilling the inclusion criteria will be
selected. Total sample size will be equally divided into three groups i.e.
RMGIC, Nanohybrid or Nanofilled Composite.
Clinical Procedure
After providing patient
information sheet to the participant, written informed consent will be
obtained.
The procedure will
be conducted with the help of
magnification (2.5X). All the participants will
have to undergo oral prophylaxis 2 weeks before the placement of restoration.
Isolation
Isolation will be done with the help of rubber dam (Coltene Whaledent, USA).
Tooth preparation for restoration
The lesions will be cleaned with
prophylaxis paste and rubber cup to remove the topped deposits at the time of
restoration. The lesions will not be prepared with rotary instruments following
the guidelines of the American Dental Association Acceptance program that do
not allow placement of bevel (26)
Restorative Procedure For Resin
Modified GIC
After isolation, the Universal adhesive system (Gluma Bond
Universal) (14) will be applied with the aid of microbrush applicator for 20
seconds then light cured for 10 seconds with the help of light curing device.
Then according to manufacturer’s instructions, the restorative material will be
manipulated and the cavity will be restored then Light cured upto 3mm depth for
20 secs.
Restorative
Procedure for Nanohybrid Composite
The
cavity will be dried with air and then Universal adhesive system (Gluma Bond
Universal) will be applied with the aid of microbrush applicator for 20 seconds
then light cured for 10 seconds with the help of light curing device. Then
according to manufacturer’s instruction, the cavity will be restored then Light
cured upto 3mm depth for 20 secs.
Restorative Procedure for Nanofilled Composite
Then cavity will be dried with air and then Universal adhesive system
(Gluma Bond Universal) will be applied with the aid of microbrush applicator
for 20 seconds then light cured for 10 seconds with the help of light curing
device. Then according to manufacturer’s |