| CTRI Number |
CTRI/2022/04/041730 [Registered on: 08/04/2022] Trial Registered Prospectively |
| Last Modified On: |
07/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinically testing the strength of the molar teeth after access cavity preparation and composite restoration |
|
Scientific Title of Study
|
In vivo strain analysis of molars before and after access cavity preparation and composite restoration |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aparnna Sreeprakash |
| Designation |
MDS Postgraduate |
| Affiliation |
Thai moogambigai dental college and hospitals |
| Address |
Department of conservative dentistry and Endodontics, Thai moogambigai dental college and hospitals, Golden George nagar, Mogappair
Chennai
TAMIL NADU
600107
India |
| Phone |
9037642418 |
| Fax |
|
| Email |
aparnnasreeprakash44@hmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AR Pradeep Kumar |
| Designation |
Professor and Head of the department |
| Affiliation |
Thai moogambigai dental college |
| Address |
Department of conservative dentistry and Endodontics, Thai moogambigai dental college and hospitals, Golden George nagar, Mogappair
Chennai
TAMIL NADU
600107
India |
| Phone |
9840135711 |
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aparnna Sreeprakash |
| Designation |
MDS Postgraduate |
| Affiliation |
MGR Educational and Research Institute |
| Address |
Department of conservative dentistry and Endodontics, Thai moogambigai dental college and hospitals, Golden George nagar, Mogappair
Chennai
TAMIL NADU
600107
India |
| Phone |
9037642418 |
| Fax |
|
| Email |
aparnnasreeprakash44@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aparnna Sreeprakash, Devaragam, Pandikkad, Malappuram, Kerala, 676521 |
|
|
Primary Sponsor
|
| Name |
Aparnna Sreeprakash |
| Address |
Devaragam, Pandikkad, Valluvangadu south post, Malappuram, Kerala, 676521 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Aparnna Sreeprakash |
Thaimoogambigai dental collede and hospitals |
Room no 202, department of conservative dentistry and Endodontics
Chennai
TAMIL NADU |
9037642418
aparnnasreeprakash44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics review board of Dr. MGR educational and research institute university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients having molars with crack and a diagnosis of irreversible pulpits |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, (2) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
healthy individuals with molars having crack and a diagnosis of irreversible pulpitis |
|
| ExclusionCriteria |
| Details |
molars without cracks |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Strain alterations in the teeth after root canal treatment |
Strain alterations in the teeth immediately after root canal treatment and after 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain score VAS after root canal treatment |
pain score VAS immediately after 1 month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/04/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/04/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to investigate the bite force and coronal strain in mandibular molars with crack before and during various stages of root canal treatment. 10 patients with cracked mandibular molars with a diagnosis of irreversible pulpits were recruited.Bite force is measure using load cell for the test teeth and the contralateral control teeth. A strain gauge is placed on the buccal surface of the tooth and the strain is measured preoperatively,after access preparation, BMP, obturation and composite restoration. |