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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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