| CTRI Number |
CTRI/2024/04/066214 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A Comparison of levels of inflammatory markers in Gum Fluid levels during tooth Straightening: Aligners vs. Braces Study |
|
Scientific Title of Study
|
Comparative study on levels of RANKL and OPG in gingival crevicular fluid associated with tooth movement induced by aligners and conventional fixed orthodontic treatment: A prospective 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 Taanvi Miglani |
| Designation |
Post graduate student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College
Department no.3 ground floor
School of Dental Sciences
MRIIRS Surajkund Road
Faridabad
Faridabad
HARYANA
121003
India |
| Phone |
9891789695 |
| Fax |
|
| Email |
drtaanvimiglani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet Batra |
| Designation |
Professor and Head of the department |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College
Department no.3 ground floor
School of Dental Sciences
MRIIRS Surajkund Road
Faridabad
Faridabad
HARYANA
121003
India |
| Phone |
9810335961 |
| Fax |
|
| Email |
drpuneetbatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Kumar Singh |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College
Department no.3 ground floor
School of Dental Sciences
MRIIRS Surajkund Road
Faridabad
Faridabad
HARYANA
121003
India |
| Phone |
8377878380 |
| Fax |
|
| Email |
drashish.singh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College Department no.3 ground floor School
of Dental Sciences MRIIRS Surajkund Road Faridabad
Faridabad
HARYANA
121003
India |
|
|
Primary Sponsor
|
| Name |
Dr Taanvi Miglani |
| Address |
Manav Rachna Dental College
Department no.3 ground floor
School of Dental Sciences
MRIIRS Surajkund Road
Faridabad |
| 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 |
| Dr Taanvi Miglani |
Manav Rachna Dental College |
Manav Rachna Dental College
Department no.3 ground floor
School of Dental Sciences
MRIIRS Surajkund Road
Faridabad
Faridabad
HARYANA |
9891789695
drtaanvimiglani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clear Aligners |
GCF samples will be collected from patients who are undergoing orthodontic treatment using clear aligners at various points in time: T0-before intervention, T1-24 hours after intervention,T2- 21 days after intervention and T4- 6 months after intervention for the assessment of bone metabolism biomarkers RANKL and OPG. |
| Comparator Agent |
Fixed Orthodontic Treatment |
GCF samples will be collected from patients who are undergoing fixed orthodontic treatment at various points in time: T0- before intervention, T1- 24 hours after intervention, T2-21 days after intervention and T3- 6 months after intervention for the assessment of bone metabolism biomarkers RANKL and OPG. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Bimaxillary protrusion cases that require extraction of all 1st premolars for orthodontic correction.
No history of antibiotics and anti-inflammatory drugs in past 6 months preceding the study.
Periodontally healthy, with generalised probing depth less than or equal to 3 mm.
|
|
| ExclusionCriteria |
| Details |
Presence of gingivitis and periodontitis
Presence of Systemic disease
Presence of bone disease
History of previous orthodontic treatment
Smoking habit
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in the levels of biomarkers will be assessed. |
T0- GCF collected at beginning of treatment
T1 - GCF collected 24 hours after intervention.
T2- GCF collected after 21 days of intervention
T4 – GCF collected after 6 months of intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of RANKL/OPG ratio. |
T0- GCF collected at beginning of treatment
T1 - GCF collected 24 hours after intervention.
T2- GCF collected after 21 days of intervention
T4 – GCF collected after 6 months of intervention
|
|
|
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 4 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| 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="2"
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
|
This prospective study aims to assess changes in bone metabolism biomarkers RANKL and OPG in gingival crevicular fluid (GCF) of
patients undergoing treatment with clear aligners and fixed orthodontic
treatment. Clear
aligners, which are a
newer orthodontic treatment modality, have not been explored extensively for
changes in biologic mediators with the application of orthodontic forces.
A
long-term assessment of changes in biomarkers in biological fluids can provide
evidence of changes at the biological level and its efficacy when compared to
conventional fixed orthodontic treatment.
The study will comprise of 20 patients of age group 15- 30 years willing to undergo orthodontic treatment with clear aligners and fixed orthodontic treatment. The gingival crevicular fluid samples of 10 patients with bimaxillary protrusion from each group, who have been subjected to extraction of all premolars, will be collected before beginning the treatment, 24 hours after intervention, 21 days after intervention, and after 6 months of intervention. |