| CTRI Number |
CTRI/2024/11/076370 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate formation of cracks after root canal treatment in older patients |
|
Scientific Title of Study
|
Evaluation of root dentin cracks |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVimalaRanjhaniVS |
| Designation |
PG student |
| Affiliation |
Thai Moogambigai Dental College and Hospital |
| Address |
Department of Conservative dentistry and Endodontics
Thai Moogambigai Dental College and Hospital
Golden George Nagar
Mugappair
Chennai
Chennai
TAMIL NADU
600107
India |
| Phone |
8056637047 |
| Fax |
|
| Email |
vimalaranjhani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrARPradeep 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
Mugappair
Chennai
Chennai
TAMIL NADU
600107
India |
| Phone |
9840135711 |
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVSVimala Ranjhani |
| Designation |
PG student |
| Affiliation |
Thai Moogambigai Dental College and Hospital |
| Address |
Department of Conservative dentistry and Endodontics
Thai Moogambigai Dental College and Hospital
Golden George Nagar
Mugappair
Chennai
Chennai
TAMIL NADU
600107
India |
| Phone |
8056637047 |
| Fax |
|
| Email |
vimalaranjhani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Thai Moogambigai Dental College and Hospital
Golden George Nagar
Mugappair
Chennai
Tamil Nadu 600107 |
|
|
Primary Sponsor
|
| Name |
DrVimalaRanjhaniVS |
| Address |
Department of Conservative dentistry and Endodontics
Thai Moogambigai Dental College and Hospital
Golden George Nagar
Mugappair
Chennai |
| 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 |
| DrVimalaRanjhaniVS |
Thai Moogambigai Dental College and Hospital |
Room no - 402,
3rd floor, PG division,
Department of conservative dentistry and endodontics,
Thai Moogambigai Dental College and Hospital, Golden George Nagar, Mugappair east.
Chennai
TAMIL NADU |
8056637047
vimalaranjhani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE,Dr.MGR EDUCATIONAL INSTITUTE AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Vital Mandibular anteriors with single straight root canals and fully formed apex.
Teeth shouls be intact without any previous fracture,caries or any endodontic treatment. |
|
| ExclusionCriteria |
| Details |
Root fractures
Root canal treated teeth
Caries
Periapical lesion
Immature apex |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Formation of root dentin cracks |
Outcome evaluated immediately after root canal instrumentation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary outcome |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/11/2024 |
| 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="1"
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
|
The purpose of this study is to evaluate the root dentin cracks after root canal instrumentation in older patients with micro computed tomography. Fifty teeth (age>50 yrs) patients with intact lower anterior teeth indicated for extraction and eight extracted teeth will be selected and divided into 1.Diabetic (n-20), 2.Non Diabetic (n-20) , 3.Overinstrumented (n-5) and 4.Negative control groups with no instrumentation (n-5). Overinstrumented group consists of extracted teeth with preparation beyond 3mm. In Diabtetic and Non Diabetic groups, teeth will be extracted using atraumatic technique after instrumentation. Teeth from the above groups will be subjected to Micro Computed Tomography scans for detection of microcracks in root dentin. The incidence of microcracks in each sample will be recorded and statistically analysed. |