| CTRI Number |
CTRI/2025/05/086641 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical evaluation of two composite materials in primary molars |
|
Scientific Title of Study
|
A comparative clinical evaluation of a bioactive restorative material versus bulk- fill composite - A randomized clinical 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 |
Dr Mary Verghese |
| Designation |
Pg student |
| Affiliation |
Sri Venkateshwaraa Dental College |
| Address |
Room no: 319
Department of Pediatric and Preventive Dentistry
Sri Venkateshwaraa Dental college
13 A pondy Villupuram main road Ariyur Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
09840176057 |
| Fax |
|
| Email |
mjnmary174@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shanmugavadivel G |
| Designation |
Professor and HOD |
| Affiliation |
Sri Venkateshwaraa Dental college |
| Address |
Room no: 319
Department of Pediatric and Preventive Dentistry
Sri Venkateshwaraa Dental college
13 A pondy Villupuram main road Ariyur Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
7358658687 |
| Fax |
|
| Email |
shanpedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shanmugavadivel G |
| Designation |
Professor and HOD |
| Affiliation |
Sri Venkateshwaraa Dental college |
| Address |
Room no: 319
Department of Pediatric and Preventive Dentistry
Sri Venkateshwaraa Dental college
13 A pondy Villupuram main road Ariyur Puducherry
PONDICHERRY
605102
India |
| Phone |
7358658687 |
| Fax |
|
| Email |
shanpedo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa Dental College, Ariyur,
Puducherry- 605102 |
|
|
Primary Sponsor
|
| Name |
Dr Mary Verghese |
| Address |
Room no: 319
Department of Pediatric and Preventive Dentistry
Sri Venkateshwaraa Dental college
13 A pondy Villupuram main road Ariyur Puducherry-605102 |
| 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 Mary Verghese |
Sri Venkateshwaraa Dental College |
Room no: 319
Department of Pediatric and Preventive Dentistry
Sri Venkateshwaraa Dental college
13 A pondy Villupuram main road Ariyur Puducherry
Pondicherry
PONDICHERRY |
9840176057
mjnmary174@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwaraa dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dentsply Sirona
SDR plus bulk fill flowable |
Flowable composite for bulk filling technology |
| Intervention |
Pulpdent- Activa kids
bioactive restorative |
ACTIVAT™ KIDS is the first dental restorative with a bioactive resin matrix, shock-absorbing resin component, and reactive ionomer glass fillers that mimic the physical and chemical properties of natural teeth. It is moisture-friendly and contains no Bisphenol A, No Bis-GMA, and No BPA derivatives. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children
Behavior rating of 3 or 4 according to the Frankl scale
Both male and female, aged between 5-9yrs
Caries lesions of class I
The caries had to be an ICDAS score of 4 & 5 |
|
| ExclusionCriteria |
| Details |
Presence of systemic diseases.
Uncooperative children
Teeth with discoloration
Developmental defects
Pathological mobility.
Pulp exposure or indication for endodontic treatment or extraction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical performance i.e., functional esthetic and biological properties of the restorative materials using FDI criteria |
3months
6months
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
19/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/05/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
The title of the study is "A Comparative clinical evaluation of a bioactive restorative material versus bulk- fill composite, for a one year- A randomized clinical trial. The aim of the study is to evaluate the clinical performance of bioactive composite with that of conventional bulk fill composite in class I carious lesion of primary molars at the end of year using FDI criteria. Th objective is to assess the clinical performance i.e. functional, esthetic, and biological properties of bioactive bulk-fill composite restoration with that of the conventional bulk -fill composite restoration in class I carious lesion of primary molars using FDI criteria at the end of one year. It is a double blinded randomized clinical trial which consists of two groups i.e. test group and the control group. The total sample size is 42 teeth, each group consists of 21 teeth. The procedure done for the test group is bioactive bulk fill composite placed in class I carious lesion in primary molars, the procedure done for control group is bulk - fill composite placed in class I carious lesion in primary molars. The inclusion criteria include healthy children of age group 5-9 years with a behavior rating scale of 3 and 4 according to Frankl with class I carious lesion, and caries of ICDAS score of 4 and 5. Exclusion criteria include uncooperative children with systemic disease, developmental defects, teeth with discoloration pathological mobility and teeth with pulpal exposure or indicated for extraction. The clinical evaluation of the materials is done by 3, 6, 12 months recall using FDI criteria i.e. functional, biological, esthetic properties. |