| CTRI Number |
CTRI/2025/07/091453 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of skeletal and dentoalveolar changes associated with two miniscrews versus for miniscrews assisted rapid palatal expansion using cone beam computed tomography |
|
Scientific Title of Study
|
Comparative evaluation of skeletal and dentoalveolar changes using two miniscrews versus four miniscrews assisted rapid palatal expansion in young adult patients with a transverse skeletal discrepancy: a cone-beam computed tomography 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 |
Anisha Rajan C M |
| Designation |
PG student |
| Affiliation |
Governmnet Dental College and hospital, Mumbai |
| Address |
Room number 206, Government dental college and hospital, st george hospital compound
behind cst, fort
Mumbai
MAHARASHTRA
400001
India |
| Phone |
08921364640 |
| Fax |
|
| Email |
anisharajancm2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sumeet Ghonmode |
| Designation |
Guide |
| Affiliation |
Governmnet Dental College and hospital, Mumbai |
| Address |
Room number 206, Government dental college and hospital, st george hospital compound
behind cst, fort
MAHARASHTRA
400001
India |
| Phone |
08921364640 |
| Fax |
|
| Email |
sumeet_ghonmode@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Anisha Rajan C M |
| Designation |
PG student |
| Affiliation |
Governmnet Dental College and hospital, Mumbai |
| Address |
Room number 206, Government dental college and hospital, st george hospital compound
behind cst, fort
MAHARASHTRA
400001
India |
| Phone |
08921364640 |
| Fax |
|
| Email |
anisharajancm2@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anisha Rajan C M |
| Address |
Government dental college and hospital, St. George hospital compound, Behind CST, Fort, Mumbai, India-400001 |
| 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 ANISHA RAJAN C M |
Government Dental college and hospital |
Room number 206, Government dental college and hospital, st george hospital compound
behind cst, fort
Mumbai
MAHARASHTRA |
08921364640
anisharajancm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee, Government Dental college and hospital, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with transverse maxillary deficiency |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
four screw minimplant group |
four screw miniimplant assisted rapid palatal expansion is given in patients with a transverse maxillary deficiency |
| Intervention |
two screw miniimplant group |
two screw miniimplant assisted rapid palatal expansion is given in patients with a transverse maxillary deficiency |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects in the age group 15-30 years of either gender indicated for maxillary expansion.
2. Subjects with healthy periodontal tissues.
3. Subjects with no prior history of orthodontic treatment / orthognathic surgery
|
|
| ExclusionCriteria |
| Details |
1. Pharyngeal pathologies
2. Nasal obstruction, snoring
3. Obstructive sleep apnoea
4. Adenoidectomy, tonsillectomy
5. Patient allergic to Local anesthetic
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To analyse skeletal and dental effects following two mini screws assisted rapid palatal expansion
2)To analyse skeletal and dental effects following four mini screws assisted rapid palatal expansion
|
baseline, 5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the skeletal effects following two mini screws versus four mini screws assisted rapid palatal expansion
To compare the dentoalveolar effects following two mini screws versus four mini screws assisted rapid palatal expansion
|
baseline, 5weeks |
|
|
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)
|
05/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="5" |
|
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
|
Transverse maxillary deficiency is considered a common
problem, affecting 7.9% of adolescents and nearly 10% of
adults. Rapid
palatal expansion (RPE) has been widely used in the field of orthodontics since
the mid-1960s for increasing the transverse dimensions of the maxilla in
growing patients. Rapid palatal expansion enables the separation of
the mid palatal suture, which is followed by skeletal orthopaedic expansion. Conventional
tooth-anchored RME could cause
dentoalveolar tipping, less skeletal movement, and a lack of long-term
stability. This tipping is usually accompanied by some
extrusion.These dentoalveolar changes can contribute to vertical
changes.
However, the fused, mature mid palatal suture and adjacent
articulations limit the desired results for nongrowing patients using
conventional RME. To reduce possible unwanted side effects and
limitations of conventional RME, Mini-implant assisted rapid palatal expansion
appliance (MARPE) was designed to increase the maxillary width in nongrowing
patients using mini-implants placed in the cortical bone of the palate and
nasal floor (NF).
MARPE
could produce more favourable orthopaedic and less dentoalveolar side effects
as compared with conventional tooth-borne RME. There is scarcity of evidence in literature to
compare two screws MARPE appliance and four screws MARPE appliance regarding
skeletal and dentoalveolar effects. Four
mini screws have more skeletal anchorage than two mini screws mini-implants due
to increased number of implants and increase in amount of surface area. This
study is done to compare the differences in skeletal and dentoalveolar changes
between two screws mini-implant and four screws mini-implant
|