| CTRI Number |
CTRI/2024/08/072888 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Chairside identification of dental trauma consequences. |
|
Scientific Title of Study
|
Accuracy of inflammatory biomarkers using GCF compared to CBCT in diagnosis of root resorption in luxation injuries in permanent dentition- A clinical 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 Anvitha M |
| Designation |
Postgraduate student |
| Affiliation |
Meenakshi Ammal dental college and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics
Postgraduate section, Room no 9, Meenakshi Ammal dental college and Hospital
Alapakkam main road
Maduravoyal
Chennai
TAMIL NADU
600095
India |
| Phone |
09884209545 |
| Fax |
|
| Email |
anvitham203@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandini Suresh |
| Designation |
Professor |
| Affiliation |
Meenakshi Ammal dental college and Hospital |
| Address |
Department of Conservative dentistry and Endodontics, Postgraduate section, Room no 9, Meenakshi Ammal dental college and Hospital
Alapakkam main road
Maduravoyal
Chennai
TAMIL NADU
600095
India |
| Phone |
9884292850 |
| Fax |
|
| Email |
nandini.endo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anvitha M |
| Designation |
Postgraduate student |
| Affiliation |
Meenakshi Ammal dental college and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, Postgraduate section, Room no 9, Meenakshi Ammal dental college and Hospital
Alapakkam main road
Maduravoyal
Chennai
TAMIL NADU
600095
India |
| Phone |
09884209545 |
| Fax |
|
| Email |
anvitham203@gmail.com |
|
|
Source of Monetary or Material Support
|
| Meenakshi Ammal dental college and hospital, Alapakkam Main road, Maduravoyal, Chennai- 600095, Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Anvitha M |
| Address |
Meenakshi Ammal dental college and Hospital
Alapakkam Main Road, Maduravoyal
Chennai- 600095, TamilNadu, India |
| 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 Anvitha M |
Meenakshi Ammal Dental college and hospital |
Department of Conservative dentistry and Endodontics, Postgraduate section, Room no 9, Meenakshi Ammal dental college and Hospital
Alapakkam main road
Maduravoyal
Chennai
TAMIL NADU |
9884209545
anvitham203@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee, Meenakshi Ammal Dental college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S025||Fracture of tooth (traumatic), (2) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Systematically healthy patients (ASA 1,2,3)
2. Traumatic (Luxation injury) to the permanent teeth.
3. Time of up to 7-10 days after trauma. |
|
| ExclusionCriteria |
| Details |
1. Retrauma patients.
2. Exisiting pulp canal obliteration or resorption.
3. Periodontitis patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This information will help in designing a chair side product for biomarkers as a diagnostic aid in luxation injuries to assess root resorption. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The correlation to CBCT and inflammatory markers can aid in reducing the need to take multiple CBCT scans during the follow up period. |
1 year |
|
|
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)
|
16/09/2024 |
| 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)
|
Open to Recruitment |
| 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 clinical single arm study aims in finding the accuracy of inflammatory biomarkers using gingival crevicular fluid to Cone beam computed tomography scans in the diagnosis of root resorption in luxation injuries of permanent teeth. The study will be conducted on patients between 18- 35 years of age in Meenakshi Ammal dental college and hospital. The primary outcome will help in diagnosing a chair side product for biomarkers as a diagnostic aid in luxation injuries to assess root resorption. The secondary outcome will help correlate inflammatory biomarkers to CBCT scan and thus reduce the need to take multiple scans during follow up period.
|