| CTRI Number |
CTRI/2025/08/092633 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to develop a standardized 3D printed guide for treating calcified root canals in single-rooted teeth |
|
Scientific Title of Study
|
Establishing a standardized protocol for three-dimensional printed endodontic guide in management of calcified canals of single rooted tooth – a 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 |
DR FARHA KHATOON |
| Designation |
Ph.D. student |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth
Sant Tukaram Nagar, Pimpri, Pune-411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8709528385 |
| Fax |
|
| Email |
farhak0312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Surendraprasad Mishra |
| Designation |
Professor and Head, Ph.D. Guide |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth
Sant Tukaram Nagar, Pimpri, Pune-411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9890515247 |
| Fax |
|
| Email |
aegisthesunil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Surendraprasad Mishra |
| Designation |
Professor and Head, Ph.D. Guide |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth
Sant Tukaram Nagar, Pimpri, Pune-411018
MAHARASHTRA
411018
India |
| Phone |
9890515247 |
| Fax |
|
| Email |
aegisthesunil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Dr. D. Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune – 411018 |
| Type of Sponsor |
Other [Dental 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 Sunil Surendraprasad Mishra |
Dr. D. Y. Patil Dental College and Hospital |
Department of Oral Medicine and Radiology, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune-411018
Pune
MAHARASHTRA |
9890515247
aegisthesunil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endodontic guide |
Type of Intervention:
Procedure / Device-based Intervention
Description:
Patients with radiographically confirmed calcified canals in single-rooted teeth will undergo guided endodontic access preparation using a customized 3D-printed endodontic guide.
The guide will be designed using CBCT data and intraoral STL scans with Romexis® Implant Planning and Surgical Guide Module.
The guide will be printed using SprintRay Pro 95 3D printer and D-Tech 3D Accuprint resin.
The guide will direct the access preparation path for root canal therapy, ensuring minimal invasion and accurate localization of the calcified canal.
Root canal therapy will be completed using conventional endodontic techniques after guided access.
Route of Administration:
Intraoral application during endodontic procedure
Dosage / Frequency / Mode:
Single use, performed once during endodontic access preparation
Duration of Intervention:
Single appointment (Day 0) for guided access and initiation of root canal therapy. Additional appointments as per routine clinical protocol for RCT completion. |
| Comparator Agent |
None (single-arm clinical study) |
This is a single-arm clinical study; no active comparator or control group is involved. All patients will receive the intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Single rooted maxillary/mandibular tooth
Radiographic evidence of canal calcification at any level (cervical/middle/apical)
Patient provides informed consent |
|
| ExclusionCriteria |
| Details |
Allergy to resin
Tooth fracture
External root resorption on radiograph |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison between virtual (planned) and actual canal access path using CBCT imaging – angular and linear deviation |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment feasibility & completion of root canal therapy using 3D printed guide |
baseline |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
01/09/2025 |
| 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="2"
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
|
This study aims to help patients with calcified root canals in single-rooted teeth. A customized 3D printed guide will be created using CBCT scans and planning software to assist dentists in precisely accessing and cleaning the canal. This is expected to make the treatment more accurate, faster, and safer. |