CTRI Number |
CTRI/2022/07/044184 [Registered on: 20/07/2022] Trial Registered Prospectively |
Last Modified On: |
19/07/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparative evaluation of three cements in healing the pulp in lower molars of milk teeth in children
|
Scientific Title of Study
|
Comparative evaluation of MTA, Biodentine and a new calcium silicate material as Pulpotomy agents in primary molars- A pilot study
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Nikitha Suzanne Varghese |
Designation |
Pg student |
Affiliation |
Saveetha Dental College |
Address |
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Thiruvallur TAMIL NADU 600077 India |
Phone |
7708528075 |
Fax |
|
Email |
nikitha.varghese@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Nikitha Suzanne Varghese |
Designation |
Pg student |
Affiliation |
Saveetha Dental College |
Address |
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Thiruvallur TAMIL NADU 600077 India |
Phone |
7708528075 |
Fax |
|
Email |
nikitha.varghese@gmail.com |
|
Details of Contact Person Public Query
|
Name |
EMG Subramanian |
Designation |
Professor and HOD of Department of Pedodontics, Saveetha Dental College |
Affiliation |
|
Address |
Clinic 28
Head of the Department
Department of a Pedodontics
Saveetha dental college
162, Poonamallee High Rd, Velappanchavadi, Chennai,
Tamil Nadu 600077
Thiruvallur TAMIL NADU 600077 India |
Phone |
|
Fax |
|
Email |
emg.subu@gmail.com |
|
Source of Monetary or Material Support
|
Saveetha Dental College and Hospital |
|
Primary Sponsor
|
Name |
Nil |
Address |
Nil |
Type of Sponsor |
Other [Self sponsor] |
|
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 Nikitha |
Saveetha Dental College |
Clinic 28, Department of Pedodontics
162, Saveetha dental college
Poonamallee high road Thiruvallur TAMIL NADU |
07708528075
drnikitha.varghese@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SIMATS |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Biodentine |
Tricalcium silicate cement manufactured by Septodont for one year |
Comparator Agent |
MTA Angelus |
Repairative cement composed of Tricalium silicate and manufactured by Angelus for one year |
Intervention |
New Calcium silicate Material |
Composed of mainly Tricalcium silicate and calcium chloride. Produced by the investigator.
For one year |
|
Inclusion Criteria
|
Age From |
4.00 Year(s) |
Age To |
13.00 Year(s) |
Gender |
Both |
Details |
Children of 4-13 years of age
Pulp exposure due to caries or after traumatic pulp exposure
No history of spontaneous pain, tooth mobility
No clinical evidence of pulpal inflammation or degeneration
Restorable teeth
Absence of radiographic evidence of internal or external resorption, pulpal calcification
|
|
ExclusionCriteria |
Details |
children with special needs
Pain
mobility |
|
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 |
Clinical and Radiographic success
(No pain or swelling) |
1 month, 3 months, 1 year |
|
Secondary Outcome
|
Outcome |
TimePoints |
Dentine bridge formation |
1 year |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
31/08/2022 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [drnikitha.varghese@gmail.com].
- For how long will this data be available start date provided 30-06-2022 and end date provided 25-06-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
|
Child from the ages of 4to9 years who visit the Department of Preventive and Paediatric dentistry, Saveetha dental college will be a apart of the trial after given consent. |