| CTRI Number |
CTRI/2025/08/093058 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Clinical evaluation of two different restorative materials in non-carious cervical lesions |
|
Scientific Title of Study
|
Clinical evaluation of a nano-ceramic composite resin and a resin-modified glass ionomer restorative in non-carious cervical lesions: a split-mouth 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 |
Sravya Tadiparthi |
| Designation |
PG 1st year |
| Affiliation |
GITAM dental college and hospital |
| Address |
Department of conservative dentistry and endodontics, room number 4, first floor, GITAM dental college, rushikonda 530045, visakhapatnam 530045, Andhra pradesh, India.
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
09247471705 |
| Fax |
|
| Email |
sravyatadiparthi8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Ravichandra Ravi |
| Designation |
Professor |
| Affiliation |
GITAM dental college and hospital |
| Address |
Department of Conservative Dentistry and Endodontics, Room number 4, first floor, GITAM dental college, Rushikonda 530045, Visakhapatnam 530045, Andhra Pradesh, India.
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9155717777 |
| Fax |
|
| Email |
raavi.ravi13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sravya Tadiparthi |
| Designation |
PG 1st year |
| Affiliation |
GITAM dental college and hospital |
| Address |
Department of conservative dentistry and endodontics, room number 4, first floor, GITAM dental college, rushikonda 530045, visakhapatnam 530045, Andhra pradesh, India.
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
09247471705 |
| Fax |
|
| Email |
sravyatadiparthi8@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sravya Tadiparthi |
| Address |
Department of conservative dentistry and endodontics, room number 4, first floor, GITAM dental college, rushikonda 530045, visakhapatnam 530045, Andhra pradesh, India. |
| 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 Sravya Tadiparthi |
GITAM dental college and hospital |
Department of conservative dentistry and endodontics, room number 4, first floor, GITAM dental college, rushikonda 530045, visakhapatnam 530045, Andhra pradesh, India.
Visakhapatnam
ANDHRA PRADESH |
09247471705
sravyatadiparthi8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee of GITAM dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Two different restorative materials (nanoceramic composite and resin modified GIC) |
Comparison of clinical performance made at baseline, 3 months, 6 months, 9 months, 12 months and 18 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with no serious systemic diseases.
Patients with at least four non-carious cervical lesions.
Patients with cervical margins in dentin.
Patient with vital pulp with the absence of symptoms of pulpitis. |
|
| ExclusionCriteria |
| Details |
Patients with a history of bruxism or parafunctional habits.
Teeth with chronic periodontal involvement and
gingival inflammation.
Teeth that are grossly decayed.
Patients with very poor oral hygiene,
Patients suffering from psychological or
neurological conditions. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the clinical performance of two different posterior restorative materials using FDI criteria |
baseline(0 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the clinical survival & performance of two different restorative materials |
3 months, 6 months, 9 months, 12 months & 18 months |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="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
|
Forty six patients with age group between 30 to 60 years who are having atleast two posterior teeth in two different quadrant with moderate non-carious cervical lesions will be recruited in the study. Selected teeth will be divided into two groups. Restoration survival and clinical performance will be evaluated at baseline, 3 months, 6 months, 9 months, 12 months and 18 month visits |