| CTRI Number |
CTRI/2024/11/076988 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of increase in hard tissue formation by two different indirect pulp capping agents in primary molars- a randomized controlled trial |
|
Scientific Title of Study
|
Evaluation of the increase in dentinal barrier thickness formed by indirect pulp treatment with two different indirect pulp capping agents in primary molars- a randomized controlled 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 |
Janaki Shaji |
| Designation |
MDS resident |
| Affiliation |
Amrita School of Dentistry |
| Address |
Room no:5, Department of pediatric and preventive dentistry, Amrita School of Dentistry, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
7558898250 |
| Fax |
|
| Email |
janakishaji99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Balagopal Varma R |
| Designation |
professor and head of the department |
| Affiliation |
Amrita School of Dentistry |
| Address |
Department of Pediatric and Preventive dentistry, Amrita School of Dentistry, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9447032358 |
| Fax |
|
| Email |
balagopalvarma@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Balagopal Varma R |
| Designation |
professor and head of the department |
| Affiliation |
Amrita School of Dentistry |
| Address |
Department of Pediatric and Preventive dentistry, Amrita School of Dentistry, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9447032358 |
| Fax |
|
| Email |
balagopalvarma@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita School of Dentistry, Amrita institute of medical sciences, Edappally, Kochi, pin: 682041 |
|
|
Primary Sponsor
|
| Name |
Janaki Shaji |
| Address |
Amrita School of Dentistry
Edapally Kochi pin:682041 |
| 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 Janaki Shaji |
Amrita school of dentistry |
Room no:5 Department of Pediatric and Preventive dentistry
Ernakulam
KERALA |
7558898250
janakishaji99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Vishwa Vidyapeetham Institute of Medical Sciences Healthcare, Education & Research |
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 |
SafeEndo BioStructure MTA putty |
composition is Tricalcium Silicate, Dicalcium silicate, Tricalcium Aluminate, Zirconium oxide, Paste forming agents
it is an indirect pulp capping agent |
| Comparator Agent |
VOCO Calcimol LC |
composition is Light-curing radiopaque calcium hydroxide paste. it is an indirect pulp capping agent |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Primary molars meeting the following criteria will be included in the study:
On clinical examination, large carious lesions involving either occlusal or proximal surfaces, with normal appearances of the gingiva will be identified.
Participants with a history of tolerable dull intermittent pain and mild discomfort associated with eating will be included.
On radiographic evaluation, primary molars with carious lesions involving more than 2/3rd thickness of dentin approximating the pulp, normal lamina dura and periodontal ligament space, and more than 2/3rd of the root present without periapical changes will be included.
|
|
| ExclusionCriteria |
| Details |
Primary molars with the following criteria will be excluded from the trial:
Having history of sharp, penetrating pulpalgia indicating acute pulp inflammation and necrosis, prolonged pain at night.
On Clinical examination, presence of mobility of tooth, discoloration of tooth, negative reaction to electric pulp testing, sinus opening or abscessed tooth.
On radiographic evaluation, carious lesion with definite pulp exposure, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency, internal or external resorption.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the increase in dentinal barrier thickness formed by two types of Indirect pulp capping agents used in the treatment of carious lesions in primary molars over a period of 12 months. |
3,6,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| follow up |
3,6,12 months |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
14/12/2024 |
| 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)
|
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
|
Primary molars to be selected from patients
aged 5 to 8 years attending the OP of the Department of Pediatric and
Preventive dentistry in Amrita school of dentistry. Primary teeth with carious lesion approaching the pulp and indicated for indirect pulp capping will be chosen. Local anesthesia will be administered following which rubber dam application will be done. Caries excavated and Indirect pulp treatment will be done with: Group 1: SafeEndo BioStructure MTA and Group 2: Light curing Calcium hydroxide (VOCO Calcimol LC). Resin modified GIC base (RMGIC) given subsequently and Composite restoration will be placed on top of base material after etching and bonding. Baseline radiograph will be taken on the same day. Patient will be recalled for review at 3 months, 6 months and 12 months. Tooth will be clinically examined and radiographically evaluated. Radiographs will be taken at 3 months, 6 months and 12 months and subsequently scanned and transferred to the computer for digital analysis. The increase in dentin thickness measured using Corel Draw software, Version 13
|