| CTRI Number |
CTRI/2025/04/084994 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To Compare the Efficacy, Efficiency and Pain Perception of three Caries Removal Techniques - Chemo-mechanical, Atraumatic Restorative Technique and Conventional Caries Removal Techniques in milk teeth. |
|
Scientific Title of Study
|
Comparative Evaluation of Novel Chemo-mechanical, Atraumatic Restorative Technique and Conventional Caries Removal Techniques in Primary Teeth - 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 Rubini M |
| Designation |
PG student |
| Affiliation |
Sri Venkateshwaraa Dental College |
| Address |
Room No. 318,
Department of Pediatric and Preventive Dentistry,
Sri Venkateshwaraa Dental College
13 A, Pondy Villupuram main road,Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
6379197022 |
| Fax |
|
| Email |
rubini2020rubi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shanmugavadivel G |
| Designation |
HOD & Professor |
| Affiliation |
Sri Venkateshwaraa Dental College |
| Address |
Room No. 318,
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 Rubini M |
| Designation |
PG student |
| Affiliation |
Sri Venkateshwaraa Dental College |
| Address |
Room No. 318,
Department of Pediatric and Preventive Dentistry,
Sri Venkateshwaraa Dental College
13 A, Pondy Villupuram main road,Ariyur, Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
6379197022 |
| Fax |
|
| Email |
rubini2020rubi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Room No.: 318,
Department of Pediatric and Preventive Dentistry,
Sri Venkateshwaraa Dental College
13 A, Pondy Villupuram Main Rd, Ariyur, Puducherry 605102 |
|
|
Primary Sponsor
|
| Name |
Dr Rubini M |
| Address |
Room No. 318,
Department of Pediatric and Preventive Dentistry,
Sri Venkateshwaraa Dental College
13 A, Pondy Villupuram main road,Ariyur, Puducherry |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rubini M |
Sri Venkateshwaraa Dental College |
Room No. 318,
Department of Pediatric and Preventive Dentistry,
Sri Venkateshwaraa Dental College
13 A, Pondy Villupuram main road,Ariyur, Puducherry
Pondicherry
PONDICHERRY |
6379197022
rubini2020rubi@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 |
| Healthy Human Volunteers |
Healthy Children aged 4 - 10 years. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Atraumatic Restorative Technique |
Atraumatic Restorative Treatment (ART) is a minimally invasive dental approach that uses hand instruments (spoon excavator) to remove caries. |
| Intervention |
Bromelain Gel |
Bromelain, a pineapple extract with anti-inflammatory and bactericidal properties, is one such chemomechanical caries removal agent.
|
| Comparator Agent |
Conventional Caries removal using airotor and round bur. |
In this method caries is excavated using conventional procedure consisting of airotor and round bur. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 4 – 10 years
Presence of occlusal caries in primary mandibular molars with International Caries Detection and Assessment System (ICDAS II).
Radiograph showing dentinal caries up to two-thirds of the dentinal thickness.
The consistency of carious lesions ranges from soft to medium hard.
Color ranges from light yellow to brown
|
|
| ExclusionCriteria |
| Details |
Extensively damaged teeth.Teeth that exhibit a history of pain.
Caries involving pulp or extending below the gingiva.
Medically or developmentally compromised conditions.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluating the efficacy, efficiency and pain perception associated with the use of bromelain gel for caries removal. |
At baseline and immediately after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy, efficiency, & pain response of caries removal using bromelain gel, atraumatic restorative technique & conventional technique.
To evaluate & compare the levels of anxiety & fear experienced by pediatric patients during caries removal with Bromelain gel, Atraumatic Restorative Treatment (ART), & the conventional technique. |
At baseline & immediately after intervention |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
05/05/2025 |
| 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
|
This study aims to compare and evaluate the clinical efficacy, efficiency, and pain response of three caries removal techniques: Bromelain gel chemo-mechanical caries removal, Atraumatic Restorative Treatment (ART), and conventional caries removal. The primary objective is to assess the efficacy, efficiency, and pain response of Bromelain gel in primary mandibular molars. Secondary objectives include evaluating and comparing ART and conventional techniques, as well as examining the anxiety and fear experienced by pediatric patients during the procedures. The study is a triple-blinded, parallel-arm, randomized clinical trial involving three groups, each consisting of 25 primary mandibular molars, for a total of 75 teeth. The intervention group will undergo Bromelain gel chemo-mechanical caries removal, while the comparison groups will receive ART and conventional caries removal. Inclusion criteria involve children aged 4 to 10 years with occlusal caries in primary mandibular molars and dentinal caries. Exclusion criteria include teeth with extensive damage, pulp involvement, or a history of pain, as well as children with medical or developmental conditions that may impact treatment. Caries removal will be evaluated through visual inspection and tactile sensation, with procedure duration recorded. Pain perception will be assessed using the Wong-Baker FACES pain scale (subjective) and the FLACC scale (objective). |