| CTRI Number |
CTRI/2025/07/091870 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Checking the amount of dentin deposition radiographically in indirect pulp capping with different material |
|
Scientific Title of Study
|
Effectiveness of new dentin substitute for indirect pulp capping – A Randomised clinical 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 |
Vigneswaran.S |
| Designation |
Post graduate |
| Affiliation |
Priyadarshini dental college and hospital |
| Address |
No 1 VGR garden VGR nagar Pandur Thiruvallur
Thiruvallur
TAMIL NADU
631203
India |
| Phone |
9500147323 |
| Fax |
|
| Email |
sekarganesan7462@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vigneswaran S |
| Designation |
Post graduate |
| Affiliation |
Priyadarshini dental college and hospital |
| Address |
No 1 VGR garden VGR nagar Pandur Thiruvallur
Thiruvallur
TAMIL NADU
631203
India |
| Phone |
9500147323 |
| Fax |
|
| Email |
sekarganesan7462@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vigneswaran S |
| Designation |
Post graduate |
| Affiliation |
Priyadarshini dental college and hospital |
| Address |
No 1 VGR garden VGR nagar Pandur Thiruvallur
Thiruvallur
TAMIL NADU
631203
India |
| Phone |
9500147323 |
| Fax |
|
| Email |
sekarganesan7462@gmail.com |
|
|
Source of Monetary or Material Support
|
| No 1 VGR garden VGR nagar Pandur Thiruvallur |
|
|
Primary Sponsor
|
| Name |
Vigneswaran S |
| Address |
NO 42/41 3rd street easwari nagar Pallavaram Chennai 600043 |
| Type of Sponsor |
Private medical college |
|
|
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 Vigneswaran S |
Priyadarshini dental college and hospital |
No 1 VGR garden VGR nagar Pandur Thiruvallur
Thiruvallur
TAMIL NADU |
9500147323
sekarganesan7462@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTE -PDCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
APPARENTLY HEALTHY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
replacement of dycal with new substitutes |
placing MTA, KEDO BIO D+ and Theracal PT |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Children between the age group of four to seven years
Vital tooth
Presence of minimum of 2/3 rd of root.
|
|
| ExclusionCriteria |
| Details |
History of pain, or tenderness upon percussion.
Presence of tooth mobility, fistula formation, internal or external root resorption or periapical pathology
Presence of chronic systemic illnesses and under long-term medication.
Patients with special health care needs.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluating the amount of dentin deposition radiographically |
evaluated for a period of one month, three month and six month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluating tooth vitality |
for a period of one month,three month, six month |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 1 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
After accessing the patients tooth status which require indirect pulp capping , the dentin substitutes are placed as a liner at the floor of the cavity. three different material-Ttheracal pt , MTA and Biodentine is placed on the floor of cavity and GIC restoration is given. Preoperative radiographs and post treatment radiographs were taken maintaining proper angulations. Reparative dentin deposition in accessed radiographically for a period of 1,3,6 and 9 month of period |