| CTRI Number |
CTRI/2024/05/068135 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
In-vivo strain alterations in posterior teeth before and after single visit root canal treatment |
|
Scientific Title of Study
|
Comparative evaluation of coronal strain alterations in posterior teeth before and after single sitting root canal treatment using a custom-made strain gauge – 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 |
Dr Neha Vijay Badgujar |
| Designation |
Post Graduate Student |
| Affiliation |
MGVs KBH Dental College And Hospital, Nashik |
| Address |
501, 502 Dept Of Conservative Dentistry and Endodontics,
MGVs KBH Dental College and Hospital, Panchavati, Nashik
Panchavati, Nashik Nashik MAHARASHTRA 422003 India |
| Phone |
9096829137 |
| Fax |
|
| Email |
nehabadgujar50@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Surbhi Patel |
| Designation |
Associate Professor and Guide |
| Affiliation |
MGVs KBH Dental College and Hospital, Panchavati, Nashik |
| Address |
501, 502 Dept Of Conservative Dentistry and Endodontics,
MGVs KBH Dental College and Hospital, Panchavati, Nashik
Nashik MAHARASHTRA 422003 India |
| Phone |
9373050500 |
| Fax |
|
| Email |
surbhi17den@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Neha Vijay Badgujar |
| Designation |
Post Graduate Student |
| Affiliation |
MGVs KBH Dental College and Hospital, Panchavati, Nashik |
| Address |
502, Dept Of Conservative Dentistry and Endodontics,
MGVs KBH Dental College and Hospital, Panchavati, Nashik
Nashik MAHARASHTRA 422003 India |
| Phone |
9096829137 |
| Fax |
|
| Email |
nehabadgujar50@gmail.com |
|
|
Source of Monetary or Material Support
|
| 502, Dept Of Conservative Dentistry and Endodontics,
MGVs KBH Dental College and Hospital, Panchavati, Nashik
|
|
|
Primary Sponsor
|
| Name |
Dr Neha Vijay Badgujar |
| Address |
502 Dept Of Conservative Dentistry and Endodontics,
MGVs KBH Dental College and Hospital, Panchavati, Nashik
|
| 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 |
| Dr Neha Vijay Badgujar |
MGVs KBH Dental College and Hospital, Panchavati, Nashik |
501 502 Dept Of Conservative Dentistry and Endodontics Nashik MAHARASHTRA |
9096829137
nehabadgujar50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KBH Dental College Institutional Ethics Committee Panchavati, Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Custom-made strain gauge will be used for the study. |
Strain gauges will be bonded to the buccal aspect of carious posterior tooth Coronal strain will be recorded before, during and after the root canal therapy under in vivo bite load on Customized strain gauge.
|
| Comparator Agent |
Healthy intact contralateral posterior tooth |
Strain gauges will be bonded to the buccal aspect of healthy intact contralateral posterior tooth and coronal strain will be recorded under in vivo bite load on Customized strain gauge. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients meeting the inclusion criteria will be considered for the present study. The coronal strain of the carious posterior tooth with symptomatic irreversible pulpitis which will undergo a single sitting root canal treatment procedure will be recorded.
Inclusion criteria:
1) Patients of the age group between 18-50 years.
2) Loss of one marginal ridge due to dental caries in posterior teeth
3) Clinical diagnosis of symptomatic irreversible pulpitis and apical diagnosis of asymptomatic periodontitis
4) Presence of opposing adjacent as well as contralateral posterior teeth with vital pulp
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1) Presence of fixed prosthesis
2) Patient undergoing active orthodontic treatment
3) Presence of Class 1 malocclusion with crossbite, posterior open bite, and posterior teeth crowding.
4) Presence of unilateral chewing habit
5) Molars with extensive occlusal dental caries, mesial and distal proximal caries or restorations, cervical caries
6) pulpal diagnosis of pulp necrosis, apical diagnosis of symptomatic apical periodontitis
7) periodontally compromised teeth
8) third molars
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is a considerable difference in coronal strain of healthy intact tooth, carious tooth and root canal treated. |
At Baseline and after the single visit root canal therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is a considerable difference in coronal strain of healthy intact tooth, carious tooth & root canal treated. |
After 1 week |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/05/2024 |
| Date of Study Completion (India) |
31/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="1" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This randomized controlled clinical trial evaluated and compared coronal strain alterations in posterior teeth before and after single-sitting root canal treatment (RCT) using a custom-made strain gauge under physiologically relevant occlusal loads. Although root canal therapy effectively preserved teeth, endodontically treated teeth were known to be biomechanically compromised due to structural loss and changes in dentin properties. Most previous assessments of strain had been performed in vitro, which did not replicate true functional conditions.
In this in vivo study, 15 patients aged 18–50 years who required single-visit RCT on carious posterior teeth were enrolled. A high-performance strain gauge was bonded to the buccal surface of the teeth to measure coronal micro-strain during maximum intercuspation. Strain values were recorded in the contralateral intact teeth, the carious tooth preoperatively, after endodontic access preparation, and after post-obturation core restoration with composite resin.
Bite force was calibrated using a digital load indicator to ensure consistent physiological loading. This study uniquely documented real-time changes in tooth deformation throughout different phases of endodontic treatment under actual clinical conditions. The results provided novel clinical insights into the biomechanical effects of single-sitting endodontic procedures and underscored the importance of restorative approaches that enhance structural reinforcement in treated teeth. |