| CTRI Number |
CTRI/2023/09/057922 [Registered on: 21/09/2023] Trial Registered Prospectively |
| Last Modified On: |
20/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of coronal strain in molar teeth |
|
Scientific Title of Study
|
Evaluation of coronal strain in molar teeth |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S MURALIDARAN |
| Designation |
PG STUDENT |
| Affiliation |
Thai Moogambigai Dental College and Hospital |
| Address |
No.15, Vijayalakshmi Avenue, Poonamallee, Chennai - 600056
Thiruvallur
TAMIL NADU
600056
India |
| Phone |
|
| Fax |
|
| Email |
muralidaran0097@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A R Pradeep Kumar |
| Designation |
Professor and Head of the department |
| Affiliation |
Thai Moogambigai Dental College and Hospital |
| Address |
Department of conservative dentistry and Endodontics,Thai
moogambigai dental college and hospital,Golden George
nagar,Mogappair,Chennai
Chennai
TAMIL NADU
600107
India |
| Phone |
9840135711 |
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A R Pradeep Kumar |
| Designation |
Professor and Head of the department |
| Affiliation |
Thai Moogambigai Dental College and Hospital |
| Address |
Department of conservative dentistry and Endodontics,Thai
moogambigai dental college and hospital,Golden George
nagar,Mogappair,Chennai
Chennai
TAMIL NADU
600107
India |
| Phone |
9840135711 |
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, Thai Moogambigai Dental College and Hospital, Golden George Nagar, Mogappair, Chennai |
|
|
Primary Sponsor
|
| Name |
Dr Muralidaran S |
| Address |
No.15, Vijayalakshmi Avenue, Poonamallee, Chennai 600056 |
| 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 |
| S Muralidaran |
Thai Moogambigai Dental College and Hospital |
Room no
202,department of
conservative dentistry
and endodontics
Chennai
Chennai
TAMIL NADU |
6369390230
muralidaran0097@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics review board of Dr M.G.R Educational And Research Institute,University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Presence of not less than 24 teeth.
Mandibular molar with dental caries with
irreversible pulpitis with one/two adjacent tooth.
Presence of opposing, and contralateral vital
counterpart to the experimental tooth.
|
|
| ExclusionCriteria |
| Details |
Patients with fixed prostheses.
Patients undergoing active orthodontic treatment.
Presence of malocclusion.
Periodontally compromised teeth.
Teeth with apical periodontitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Coronal microstrain in terminal mandibular molar teeth with irreversible pulpitis varies in comparison to intact terminal mandibular molar teeth & mandibular molar with two contacts |
before access opening after access opening after obturation after core buildup & one month followup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| bite force in terminal mandibular molar teeth with irreversible pulpitis varies in comparison to intact terminal mandibular teeth & mandibular molar with two contacts |
before local anesthesia after local anesthesia after core buildup & one month followup |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
28/09/2023 |
| 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="0"
Months="6"
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 aimed to evaluate bite force and strain alterations under occlusal load in mandibular terminal molar teeth before and after root canal treatment and intact contralateral molar with one and two contacts. Terminal mandibular molar with irreversible pulpitis is taken as test tooth and intact contralateral molar is taken as control teeth. Coronal microstrain and Bite force is evaluated before and after root canal treatment. |