| CTRI Number |
CTRI/2024/12/077929 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [Restorative dentistry] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two
different Filling materials ,in patients with caries |
|
Scientific Title of Study
|
Clinical And Comparative Evaluation of Two
Different Nanohybrid Bulk Fill Composite
Restorative Materials 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 Manshu Arora |
| Designation |
Post Graduate Student |
| Affiliation |
Maharishi Markandeshwar College of Dental Sciences and Research ,Mullana ,Ambala,Haryana |
| Address |
Department of Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research ,Mullana ,Ambala,Haryana
Ambala
HARYANA
133207
India |
| Phone |
9915999536 |
| Fax |
|
| Email |
aroramanshu53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H.P Suma Sogi |
| Designation |
head of department,department of pediatric and preventive dentistry |
| Affiliation |
Maharishi Markandeshwar College of Dental Sciences and Research ,Mullana ,Ambala,Haryana |
| Address |
Department of Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research ,Mullana ,Ambala,Haryana
Ambala
HARYANA
133207
India |
| Phone |
8197793383 |
| Fax |
|
| Email |
hod.pedodontics@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manshu Arora |
| Designation |
Post Graduate Student |
| Affiliation |
Maharishi Markandeshwar College of Dental Sciences and Research ,Mullana ,Ambala,Haryana |
| Address |
Department of Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research ,Mullana ,Ambala,Haryana
Ambala
HARYANA
133207
India |
| Phone |
9915999536 |
| Fax |
|
| Email |
aroramanshu53@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research ,Mullana ,Ambala,Haryana
pincode-133207,india |
|
|
Primary Sponsor
|
| Name |
Dr. Manshu Arora |
| Address |
Department of Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Mullana, Ambala, Haryana |
| 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 H P Suma sogi |
Maharishi Markandeshwar College of Dental Sciences and Research, Mullana, Ambala, Haryana. |
Room 4, Department of Pediatric and Preventive Dentistry.
Ambala
HARYANA |
08197793383
hod.pedodontics@mmumullana.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3M Espe Filtek Bulk Fill Composite Restorative Material |
3M Espe Filtek Bulk Fill Composite Restorative Material ( duration - 6 months ) |
| Comparator Agent |
Tetric N Ceram Bulk Fill Composite Restorative Material |
Tetric N Ceram Bulk Fill Composite Restorative Material |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Good oral hygiene
2. Minimal periodontal disease
3. Absence of deleterious habits (e.g. mouth breathing, nail biting, bruxism, and to clenching
Or grinding ) |
|
| ExclusionCriteria |
| Details |
1. Teeth with secondary caries or in need of replacement of existing restorations.
2. Patients having a history of adverse reaction to the test material.
3. Poor oral hygiene or presence of systemic disease and severe periodontal disease
4. Patients unable to attend recall visits |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Retention, marginal discoloration and marginal adaptation |
3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative sensitivity, color match and secondary caries. |
3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/12/2024 |
| Date of Study Completion (India) |
12/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aroramanshu53@gmail.com].
- For how long will this data be available start date provided 24-09-2024 and end date provided 10-09-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
This study is a randomized trial evaluating and comparing the retention, marginal discoloration, marginal adaptation of two different nano hybrid bulk fill composite restorative materials at 3 and 6 months in children aged 3 to 8 years in 44 carious teeth.the purpose of this study to compare two different bulk fill restorative materials. Bulk
fill composite have various advantages in Pediatric dentistry owing to
their easy handling and adequate properties, making them a preferred
choice. Time is the most significant factor in evaluating various factors, marginal
adaptation, marginal discoloration secondary caries post-operative
sensitivity irrespective of the material type.3M
ESPE showed statistically significant differences with respect to
retention, marginal discoloration, during study periods indicating better
short- and long-term patient comfort as
compared to Tetric-N-Ceram. |