| CTRI Number |
CTRI/2022/07/043848 [Registered on: 08/07/2022] Trial Registered Prospectively |
| Last Modified On: |
21/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the clinical effectiveness and pain perception of a caries removal agent and mechanical caries removal method in Primary teeth |
|
Scientific Title of Study
|
Comparison of clinical efficacy and pain perception with new chemomechanical caries removal agent and conventional caries removal method in primary molars : A randomized controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Seema Bargale |
| Designation |
professor |
| Affiliation |
K M Shah Dental college and hospital, Sumandeep Vidyapeeth |
| Address |
Department no. 3, Department of Pediatric and Preventive Dentistry, K M Shah Dental College , Sumandeep Vidyapeeth an institute deemed to be university, Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7016048359 |
| Fax |
|
| Email |
drseemabargale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Bargale |
| Designation |
professor |
| Affiliation |
K M Shah Dental college and hospital, Sumandeep Vidyapeeth |
| Address |
K M Shah Dental College , Sumandeep Vidyapeeth an institute deemed to be university, Waghodia, Vadodara
GUJARAT
391760
India |
| Phone |
7016048359 |
| Fax |
|
| Email |
drseemabargale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Bargale |
| Designation |
professor |
| Affiliation |
K M Shah Dental college and hospital, Sumandeep Vidyapeeth |
| Address |
K M Shah Dental College , Sumandeep Vidyapeeth an institute deemed to be university, Waghodia, Vadodara
GUJARAT
391760
India |
| Phone |
7016048359 |
| Fax |
|
| Email |
drseemabargale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sumandeep Vidyapeeth an Institute deemed to be University |
|
|
Primary Sponsor
|
| Name |
Dr Seema Bargale |
| Address |
K M Shah Dental College, Sumandeep Vidyapeeth an Institute Deemed to be university, Waghodia, Vadodara, Gujarat |
| Type of Sponsor |
Other [] |
|
|
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 Seema Bargale |
K M Shah Dental College and Hospital |
Department no. 3, Department of Pediatric and Preventive Dentistry, first floor, K M Shah Dental College, Sumandeep Vidyapeeth an Institute Deemed to be University, Waghodia, Vadodara
Vadodara
GUJARAT |
7016048359
drseemabargale@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BRIX3000 |
A new chemomechanical caries removal agent. It is a papain based agent which is encapsulated by using Encapsulating Buffer Emulsion (EBE) technology. |
| Comparator Agent |
Mechanical caries removal method |
It is a traditional means of caries removal using Airotor (high speed handpiece) |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. children having occlusal carious lesion on maxillary and/or mandibular either first or second primary molar.
2. the teeth will be selected based on the Mount and Hume classification of 1.2
3. the children whose parents will give the written informed consent for study |
|
| ExclusionCriteria |
| Details |
1. Children suffering from any illness requiring special medical care.
2. Children having teeth with pulp exposure, spontaneous pain, mobility, swelling or fistula next to the tooth, furcation or cervical lesion, and teeth with restorations, sealants or enamel defects |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical efficacy |
this parameter will be assessed after the caries removal procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain perception using Wong-Baker faces pain rating scale |
this parameter will be assessed after the caries removal procedure |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2022 |
| 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
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study will compare the clinical efficacy and pain perception of children towards the use of two different caries removal methods. First method is the traditional means of caries removal using high speed handpieces and second method is the chemomechanical means of caries removal using BRIX3000, a papain based agent. The children will be selected for the study based on the Inclusion criteria and will be allocated into either the BRIX3000 group or Conventional rotary method. The parameters to be assessed are clinical efficacy and pain perception using Wong-Baker faces pain rating scale. These parameters will be assessed after the caries removal. The outcomes of this study will determine which caries removal method will derive better clinical results along with child favourable technique. |