| CTRI Number |
CTRI/2025/03/082391 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Different Materials Used for Protecting Exposed Dental Pulp in Permanent Teeth: A Laboratory Study |
|
Scientific Title of Study
|
Comparative evaluation Of different pulp capping agents for direct pulp capping in permanent teeth - A histological ex vivo study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Elanthendral Saravanan |
| Designation |
Post graduate student |
| Affiliation |
Saveetha Dental College and Hospital Tamilnadu |
| Address |
Clinic 28,department of pediatric and preventive dentistry,Saveetha dental college,Seneerkuppam
Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
08190996644 |
| Fax |
|
| Email |
152211003.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ganesh Jeevanandan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospital Tamilnadu |
| Address |
Clinic 28,department of pediatric and preventive dentistry,Saveetha dental college,Seneerkuppam
Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
09884293869 |
| Fax |
|
| Email |
helloganz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ganesh Jeevanandan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospital Tamilnadu |
| Address |
Clinic 28,department of pediatric and preventive dentistry,Saveetha dental college,Seneerkuppam
Chennai
TAMIL NADU
600077
India |
| Phone |
09884293869 |
| Fax |
|
| Email |
helloganz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha dental college and hospitals,162,Poonamallee high road,Chennai 600077,India |
|
|
Primary Sponsor
|
| Name |
Elanthendral Saravanan |
| Address |
162,poonamallee high road,velappanchavadi,chennai |
| 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 |
| Ganesh Jeevanandan |
Saveetha dental college and hospitals |
Clinic 28,department of pediatric and preventive dentistry, Chennai,Tamil Nadu
Chennai
TAMIL NADU |
09884293869
helloganz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha dental college and hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
calcium hydroxide |
gold standard due to its strong antibacterial properties and ability to stimulate reparative dentin formation. Placed over the exposed dental pulp and the tooth is extracted after 28 days |
| Intervention |
Kedo bioD+ |
calcium silicate-based material that offers faster setting time, enhanced biocompatibility, and improved sealing ability.Placed over the exposed dental pulp and the tooth is extracted after 28 days |
| Intervention |
Kids e putty MTA |
A putty-like modification of MTA -It provides a smoother consistency, easier application and reduced setting time compared to conventional MTA.Placed over the exposed dental pulp and the tooth is extracted after 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
1.extraction for orthodontic treatment.
2.Teeth with vital pulp, confirmed using thermal and electric pulp tests.
3.Teeth free from caries, fractures, restorations, periapical pathology, or any developmental anomalies.
|
|
| ExclusionCriteria |
| Details |
1.Teeth with large carious lesions or previous restorations.
2.Presence of pulpal or periapical pathology confirmed radiographically.
3.Non-vital teeth based on clinical tests.
4.Medically compromised patients or those with systemic conditions.
5.History of trauma.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dentin bridge formation |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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="0"
Months="2"
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
|
To compare the quality of dentin bridge formation among three different pulp capping agents used for direct pulp capping in permanent teeth .Dentin bridge formation helps in maintaining the vitality of the teeth when used for pulp capping. |