CTRI Number |
CTRI/2023/04/051686 [Registered on: 17/04/2023] Trial Registered Prospectively |
Last Modified On: |
18/09/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Effects of conventional and miniscrew-assisted rapid palatal expansion |
Scientific Title of Study
|
Comparative evaluation of the skeletal and dentoalveolar effects of conventional and miniscrew-assisted rapid palatal expansion: A Randomized Clinical Trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Vivek kumar Thakur |
Designation |
Graded Specialist Orthodontics |
Affiliation |
Army Dental Centre Research and Referral |
Address |
Army Dental Centre R and R Hospital, near Subroto park. Delhi Cantt.
New Delhi 110010
New Delhi DELHI 110010 India |
Phone |
9765160641 |
Fax |
|
Email |
drvivekortho31@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vivek kumar Thakur |
Designation |
Graded Specialist Orthodontics |
Affiliation |
Army Dental Centre Research and Referral |
Address |
Army Dental Centre R and R Hospital, near Subroto park. Delhi Cantt.
New Delhi 110010
DELHI 110010 India |
Phone |
9765160641 |
Fax |
|
Email |
drvivekortho31@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Vivek kumar Thakur |
Designation |
Graded Specialist Orthodontics |
Affiliation |
Army Dental Centre Research and Referral |
Address |
Army Dental Centre R and R Hospital, near Subroto park. Delhi Cantt.
New Delhi 110010
DELHI 110010 India |
Phone |
9765160641 |
Fax |
|
Email |
drvivekortho31@gmail.com |
|
Source of Monetary or Material Support
|
Government funding agency (AFMRC project) |
|
Primary Sponsor
|
Name |
Armed Forces Medical Research Committee |
Address |
Office of the DGAFMS/DG-3B,
Ministry of Defence, Pin- 908713
c/o 56 APO |
Type of Sponsor |
Government funding agency |
|
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 |
Lt Col Vivek Kumar Thakur |
Surgery 6, New Orthodontic Block, Army Dental Centre R and R, Dhaula khuan, Delhi Cantt. |
Army Dental Centre R & R, Dhaula khuan, Delhi Cantt. New Delhi DELHI |
9765160641
thakurvivek13@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical 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 |
1. conventional maxillary expansion appliances |
Conventional maxillary expansion appliances- (a) Banded Hyrax appliance (b) Bonded Hyrax appliance. The total duration of rapid maxillary expansion intervention varies between 4 to 6 months, including the active phase of 2-4 weeks followed by the retention phase. |
Comparator Agent |
2. Mini implant assisted rapid palatal expansion (MARPE). |
with MARPE appliance also the total duration of rapid maxillary expansion intervention varies between 4 to 6 months, including the active phase of 2-4 weeks followed by the retention phase. |
|
Inclusion Criteria
|
Age From |
14.00 Year(s) |
Age To |
18.00 Year(s) |
Gender |
Both |
Details |
Transverse maxillary hypoplasia or presence of posterior crossbite |
|
ExclusionCriteria |
Details |
1. Previous h/o Orthodontic Treatment
2. Severe systemic illness
3. Syndromic and CL & P cases
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1. The skeletal expansion achieved in milimeters.
2. The dentoalveolar expansion achieved in milimeters.
|
T0 - Pretreatment
T1 - post-expansion (after consolidation and expansion appliance removal)
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1. To determine the amount of vertical changes produced by different rapid maxillary expansion appliances studied.
2. To determine the mandibular rotation produced by different rapid maxillary expansion appliances studied.
|
T0 - Pretreatment
T1 - post-expansion (after consolidation and expansion appliance removal)
|
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
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)
|
02/05/2023 |
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="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Management of skeletal discrepancies in the transverse
plane requires early intervention. Rapid Maxillary Expansion (RME) occupies a
unique niche in Orthodontics in managing transverse discrepancies.
Multiple options are available in the literature for correcting the discrepancy
in various age groups depending upon the tenacity of the mid-palatine and
circummaxillary sutures.
Biomechanically RME induces
displacement and stress patterns in the craniofacial skeleton in response to
forces applied which are clinically manifested as desirable and
undesirable responses. Different types of RME devices and techniques have been
discussed in literature such as Tooth Borne appliances and Bone borne
appliances using Simple Removable Plates, Hyrax Screws, Hass Screw, Bonded
Acrylic appliances, Banded Appliances with screws and Bone borne miniscrew-assisted rapid
palatal expansion (MARPE) appliance. Skeletal and Dental
changes are observed depending on the type of appliance, its area of operation
and the site of placement.
In the presently available literature, there are lacunae in
comparative evidence between both conventional and MARPE appliances. Hence the
study shall evaluate the skeletal and dentoalveolar effects of
conventional and miniscrew-assisted rapid palatal expansion. This study shall
provide evidence and enable the clinician to choose between the two appliances,
considering the three-dimensional effects of these appliances. |