| CTRI Number |
CTRI/2024/01/061380 [Registered on: 11/01/2024] Trial Registered Prospectively |
| Last Modified On: |
02/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of detecting orthodontic root resorption |
|
Scientific Title of Study
|
Efficacy of detecting orthodontic root resorption using Dentin Sialophosphoprotein (DSPP) biomarker in gingival crevicular fluid (GCF) of premolars subjected to orthodontic intrusive forces - A controlled clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rebekah R |
| Designation |
Postgraduate resident |
| Affiliation |
Saveetha dental college and hospitals |
| Address |
Department of Orthodontics and Dentofacial orthopaedics,
Saveetha Dental College and Hospital,
162, Poonamallee High Road, Velappanchavadi, Chennai
Department of Orthodontics and Dentofacial Orthopaedics,
Saveetha Dental College and Hospital,
162, Poonamallee High Road, Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9789822573 |
| Fax |
|
| Email |
152108001.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashwin Mathew George |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,
Saveetha Dental College and Hospital,
162, Poonamallee High Road, Velappanchavadi, Chennai
Department of Orthodontics and Dentofacial Orthopaedics,
Saveetha Dental College and Hospital,
162, Poonamallee High Road, Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9840032771 |
| Fax |
|
| Email |
ashwingeorge90@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashwin Mathew George |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,
Saveetha Dental College and Hospital,
162, Poonamallee High Road, Velappanchavadi, Chennai
Department of Orthodontics and Dentofacial Orthopaedics,
Saveetha Dental College and Hospital,
162, Poonamallee High Road, Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9840032771 |
| Fax |
|
| Email |
ashwingeorge90@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals
Saveetha University,
162, Poonamallee High Road,
velappanchavadi, Chennai - 77. |
|
|
Primary Sponsor
|
| Name |
Rebekah Raju |
| Address |
Saveetha Dental College and Hospital,
Saveetha University,
162, Poonamallee high road, Velappanchavadi, Chennai |
| Type of Sponsor |
Other [Postgraduate resident] |
|
|
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 |
| Rebekah |
Saveetha Dental College and Hospital |
Department of Orthodontics and dentofacial orthopaedics,
162, Poonamallee High Road, Velappanchavadi, Chennai
Chennai
TAMIL NADU |
9789822573
152108001.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No pathological root resorption |
| Patients |
(1) ICD-10 Condition: K033||Pathological resorption of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No orthodontic treatment |
No orthodontic intrusive forces were given on premolars |
| Intervention |
Orthodontic intrusion |
Orthodontic intrusive forces given on premolars for a period of 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Adult subjects aged 18 to 30 years with no congenital anomalies, systemic diseases, missing teeth, or a history of previous orthodontic treatment requiring malocclusion correction. |
|
| ExclusionCriteria |
| Details |
Subjects below the age group of 18 years and above the age group of 30 years, with congenital anomalies, systemic diseases, missing teeth, or a history of previous orthodontic treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate changes in the Dentin Sialophosphoprotein biomarker levels between study & control groups |
For a period of 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate root resorption craters before & after orthodontic intrusive forces.
|
12 weeks |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/01/2024 |
| 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="0"
Months="3"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [152108001.sdc@saveetha.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 26-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Root resorption is an unfavourable sequelae in orthodontic treatment. It is referred to as orthodontically induced root resorption (OIRR) . One of the major factors causing OIRR includes the orthodontic treatment techniques such as magnitude, duration and type of orthodontic force application. Early detection of teeth at risk of severe resorption is crucial . Currently, using radiographs is common; however, they are technique sensitive and cannot indicate if the process of root resorption is still active . This also leads to additional radiation exposure to the patients. Therefore, a safer, more reliable alternative method to clinically diagnose early stages of root resorption is much needed and may include detecting specific biomarkers in gingival crevicular fluid. |