| CTRI Number |
CTRI/2024/04/065197 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Rate of Orthodontic Tooth Movement with Two Minimally Invasive Techniques |
|
Scientific Title of Study
|
Comparative Evaluation of Rate of Orthodontic Tooth Movement with Two Minimally Invasive Techniques: 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 Nikita Mohelay |
| Designation |
Lecturer |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Department of Orthodontics
Manav Rachna Dental College
School of Dental Sciences
MRIIRS
121001
Faridabad
HARYANA
121001
India |
| Phone |
7974889498 |
| Fax |
|
| Email |
drnikitamohelay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikita Mohelay |
| Designation |
Lecturer |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Department of Orthodontics
Manav Rachna Dental College
School of Dental Sciences
MRIIRS
121001
Faridabad
HARYANA
121001
India |
| Phone |
7974889498 |
| Fax |
|
| Email |
drnikitamohelay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Mohelay |
| Designation |
Lecturer |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Department of Orthodontics
Manav Rachna Dental College
School of Dental Sciences
MRIIRS
121001
Faridabad
HARYANA
121001
India |
| Phone |
7974889498 |
| Fax |
|
| Email |
drnikitamohelay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College |
|
|
Primary Sponsor
|
| Name |
Nikita Mohelay |
| Address |
Manav Rachna Dental College, SDS, MRIIRS |
| 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 Nikita Mohelay |
Manav Rachna Dental College |
Department of Orthodontics
Manav Rachna Dental College
School of Dental Sciences
MRIIRS
Faridabad
HARYANA |
7974889498
drnikitamohelay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Malocclusion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Micro-osteo perforation, Interseptal bone reduction
|
Micro-osteo perforations are small punctures in the alveolar bone used to accelerate orthodontic tooth movement which will be delivered only once immediately after therapeutic extraction of first premolar
Interseptal bone reduction is a procedure to reduce the thickness of interseptal bone present between the teeth which will be done only once after extraction of first premolar |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with an age range of 16-22 years, consenting for the procedure.
2. Class I malocclusion with fully erupted maxillary canine.
3. Patients having a treatment plan of extraction of 1st premolars.
4. Patients with sound periodontal support
5. BMI in average range 18-25kg/m2
|
|
| ExclusionCriteria |
| Details |
1. Patients with long-term use of drugs affecting tooth movement.
2. Any other malocclusion.
3. Patients with systemic disease and any other extraction plan.
4. Patients with past periodontal disease/ past orthodontic history.
5. BMI above or below the average
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the reduction in the treatment time with two different accelerated orthodontic methods: Micro-osteo perforations and Interseptal Bone Reduction.
|
T0- BASELINE
T1- 30 days
T2- 60 days
T3- 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess and quantify the effect of Micro- osteoperforations and Interseptal Bone Reduction on the rate of tooth movement.
2. To compare the rate of OTM between Micro- osteoperforations and Interseptal Bone Reduction.
3. To evaluate the rotational effect and root movement of canine.
|
T0- BASELINE
T1- 30 days
T2- 60 days
T3- 90 days |
|
|
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)
|
17/04/2024 |
| 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="0"
Months="6"
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 - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drnikitamohelay@gmail.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Numerous methods targeting the dynamics of bone physiology increase the levels of osteoclasts to bring about bone remodelling via RANK-RANKL pathway, thus altering the rate of tooth movement. to the manner in which supporting bone responds to applied orthodontic forces.Although accelerated orthodontics is a proven phenomenon, but the gap in the knowledge lies in the effectiveness of various procedures in the different population. To gauge the interest of the population to avail a faster orthodontic treatment, a survey study demonstrated that adolescents wish for a treatment length of 6 months or less, while the adults wish for the treatment to last between 6 to 12 months. However, the average orthodontic treatment extends up to 24 months, which seemed long for the patients undergoing the treatment. In order to achieve a reduced treatment time, in the current study, we are comparing two minimally invasive techniques, namely: Micro-osteo perforations and Interseptal Bone Reduction, to assess the rate of accelerated tooth movement.
|