| CTRI Number |
CTRI/2026/04/107425 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Well Two Different Dental Post Systems Perform and Stay in Place in Severely Damaged Front Primary Teeth – A Clinical Study |
|
Scientific Title of Study
|
Comparative Evaluation of clinical performance and retention of a conventional fibre post with Uniblock post and core system in mutilated primary anterior teeth – An in 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 |
Shubham Dole |
| Designation |
Postgraduate Student |
| Affiliation |
|
| Address |
Dr. D Y Patil Dental College and Hospital Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9420200098 |
| Fax |
|
| Email |
shubhamdole@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nilesh Rathi |
| Designation |
Professor and Head of Department |
| Affiliation |
Dr. D Y Patil Dental College and Hospital Pimpri |
| Address |
Department of pediatric and preventive Dentistry, Dr. D Y Patil Dental College and Hospital Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9960100010 |
| Fax |
|
| Email |
nilesh.rathi@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Shubham Dole |
| Designation |
Postgraduate Student |
| Affiliation |
Dr. D Y Patil Dental College and Hospital Pimpri |
| Address |
Dr. D Y Patil Dental College and Hospital Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9420200098 |
| Fax |
|
| Email |
shubhamdole@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D Y Patil Dental College and Hospital Pimpri |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Nilesh Rathi |
Dr D Y Patil Dental College and Hospital, Pimpri, Pune 411018 |
Department of Pediatric and Preventive Dentistry
Dr D Y Patil Dental College and Hospital, Pimpri, Pune 411018
Pune
MAHARASHTRA |
9960100010
shubhamdole@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub Committee, Dr. D Y Patil Dental College and Hospital, Dr D Y Patil Vidyapeeth, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Presence of Dental Caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional fibre post and core |
Evaluation of clinical performance and retention of a Conventional fibre post and core in mutiliated primary anterior teeth. |
| Comparator Agent |
Uniblock post and core system |
Evaluation of clinical performance and retention of Uniblock post and core system in mutiliated primary anterior teeth |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Patients with mutilated anterior teeth with loss of crown structure
Teeth with root length more than 8mm
Teeth having minimum 1mm of intact, supra-gingival and non-carious crown structure
|
|
| ExclusionCriteria |
| Details |
Patients with any systemic disease
Patients with any Psychological and Neurological disorder
Patients with Frankl’s behavioural scale of 1 and 2
Patients having Deep bite
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Uniblock posts will have better retention as compared to conventional glass fibre post for rehabilitation of mutilated primary anterior teeth. |
1 month, 3 months, 6 months, 9 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Parental Satisfaction |
1 month, 3 months, 6 months, 9 months, 12 months |
|
|
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)
|
15/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/04/2026 |
| 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)
|
Open to Recruitment |
| 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
|
Preservation of primary teeth before premature exfoliation/ extraction due to extensive caries is one of the major concern in pediatric dentistry. The Uniblock post will aid in providing strength in severely mutilated teeth and preserve them in the oral cavity for a longer period. |