| CTRI Number |
CTRI/2025/07/091620 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of four different tooth colored material in non-carious cervical lesions-Randomized clinical trial |
|
Scientific Title of Study
|
Clinical evaluation and comparison of four different types of tooth coloured restorative materials in non-carious class V lesions –An In vivo 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 |
Dr Apeksha Surse |
| Designation |
Post Graduate Student |
| Affiliation |
Aditya Dental College Beed |
| Address |
Department of Conservative and Endodontics At Aditya Dental College and Hospital Sarda Estate Near Nalwandi Naka College Road Beed Maharashtra 431122
Department of Conservative and Endodontics At Aditya Dental College and Hospital Sarda Estate Near Nalwandi Naka College Road Beed Maharashtra 431122
Bid
MAHARASHTRA
431122
India |
| Phone |
7821070358 |
| Fax |
|
| Email |
drapekshaofficialendo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Robert Justin |
| Designation |
Professor and Head |
| Affiliation |
Professor and Head |
| Address |
Department of Conservative and Endodontics At Aditya Dental College and Hospital Sarda Estate Near Nalwandi Naka College Road Beed Maharashtra 431122
Department of Conservative and Endodontics At Aditya Dental College and Hospital Sarda Estate Near Nalwandi Naka College Road Beed Maharashtra 431122
Bid
MAHARASHTRA
431122
India |
| Phone |
8668573213 |
| Fax |
|
| Email |
himanshu.srivastava97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himanshu Srivastava |
| Designation |
Professor and Head |
| Affiliation |
Professor and Head |
| Address |
Department of Oral & Maxillofacial Pathology and Microbiology Aditya Dental College and Hospital Near Nalwandi naka Pimpalner Road Beed
Maharashtra 431122
Department of Oral & Maxillofacial Pathology and Microbiology Aditya Dental College and Hospital Near Nalwandi naka Pimpalner Road Beed
Maharashtra 431122
Bid
MAHARASHTRA
431122
India |
| Phone |
8668573213 |
| Fax |
|
| Email |
himanshu.srivastava97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative and Endodontics Aditya Dental College and Hospital Near Nalwandi naka Pimpalner Road Beed
Maharashtra 431122 |
|
|
Primary Sponsor
|
| Name |
Dr Apeksha Surse |
| Address |
Department of Conservative and Endodontics Aditya Dental College and Hospital Near Nalwandi naka Pimpalner Road Beed
Maharashtra 431122 |
| Type of Sponsor |
Other [Post Graduate Student] |
|
|
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 Apeksha Surse |
Aditya Dental College and Hospital |
Room No.7, Department of Conservative Dentistry and Endodontics Aditya Dental College Beed Maharashtra
Bid
MAHARASHTRA |
7821070358
drapekshaofficialendo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aditya Dental College and Hospital Beed Maharashtra |
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 |
Flowable compomer |
Compomers are designed to combine the benefits of GIC and composite, offering fluoride release and aesthetics makes it a better comparator follow-up of 6 months was taken after restoring it in NCCL |
| Comparator Agent |
Giomer |
Giomer restorative material offers enhanced fluoride release and potentially better esthetics than GIC makes it a good comparator which was observed for 6 months follow-up after restoration in NCCL |
| Intervention |
Glass Ionomer Cement |
GIC is used as restoration material in treating Non carious cervical lesion due to its fluoride releasing property and good retention. This was observed for 6 months follow-up |
| Comparator Agent |
High strength composite restorative material |
Composite restorative materials are widely used restorative materials due to its esthetic property so can be used to treat NCCL and also has good strength which makes it a good comparator for other materials which was observed for 6 months follow-up after restoration in NCCL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The participants having fair oral hygiene and vital teeth in age group of 20-60 years old are included The participants having proper occlusal and interproximal contact are included |
|
| ExclusionCriteria |
| Details |
The participants with poor oral hygiene were excluded also participants having carious and discolored tooth are excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The difference in the performance of the four different tooth colored materials namely GIC Giomer Flowable compomer High strength composite material was seen in the four aspect to be observed namely staining marginal discoloration surface roughness and retention till the 6 months follow up visit |
This was seen for 15 days 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="79"
Sample Size from India="79"
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)
|
07/08/2025 |
| 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="0"
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
|
Purpose of this study was to evaluate and compare the efficacy of four different tooth coloured restorative materials in non-carious cervical lesion in aspect of retention,marginal discolouration,surface roughness and staining.For this study Four experimental groups were made as twenty patients in each group.The groups were namely Group I (GIC),Group II (Giomer),Group III(Flowable Compomer), Group IV(High strength composite restorative material) containing twenty patients in each group (n=20). Statistical analyses was done using Fischer exact test.The results stated that there is no significant difference between all four restorative materials,as they are particularly better in of those aspect teted for the study. According to this study’s findings, glass ionomer cement has superior retention when it comes to retention properties, followed by Giomer, high strength restorative material (composite), and flowable compomer. Giomer and glass ionomer cement have the strongest stain resistance, whereas flowable compomer and high strength restorative materials (composite) shows least resistance to staining. However, the restorations performed similarly in terms of surface texture and marginal discolouration, because Giomer outperforms high strength composite restorative material, followed by glass ionomer cement and flowable compomer. |