| CTRI Number |
CTRI/2026/03/106408 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Diagnostic
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Changes in the Upper Jaw and Teeth After Using Two Different Expanders for Widening the Upper Jaw |
|
Scientific Title of Study
|
Comparison of Skeletal and Dentoalveolar Changes After Maxillary Expansion Using MARPE and Hybrid Hyrax Appliance in the Maxilomandibular Complex |
| 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 Albin Joji |
| Designation |
1st Year PG student MDS |
| Affiliation |
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL VIDYANAGAR HASSAN 573201
Hassan
KARNATAKA
573201
India |
| Phone |
6238002394 |
| Fax |
|
| Email |
dralbinjoji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reji Abraham |
| Designation |
PROFESSOR AND HEAD. DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS. |
| Affiliation |
PROFESSOR AND HEAD. DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS. |
| Address |
DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL VIDYANAGAR HASSAN 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9947357788 |
| Fax |
|
| Email |
drrejiortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reji Abraham |
| Designation |
PROFESSOR AND HEAD. DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS. |
| Affiliation |
PROFESSOR AND HEAD. DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS. |
| Address |
DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL VIDYANAGAR HASSAN 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9947357788 |
| Fax |
|
| Email |
drrejiortho@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Hasanamba Dental College and Hospital. |
| Address |
Sri Hasanamba Dental College and Hospital. Vidya Nagar Hassan Karnataka 573201 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Albin Joji |
SRI HASSANAMABA DENTAL COLLEGE AND HOSPITAL |
Dr. Albin Joji Sri Hassanamba Dental college and Hospital Room No:7 Vidhya Nagar Hassan Karnataka HASSAN, KARNATAKA 573201 India Mobile :6238002394
Hassan
KARNATAKA |
6238002394
dralbinjoji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Sri Hasanamba Dental College and Hospital Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M260||Major anomalies of jaw size, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HYBRID HYRAX |
Maxillary expansion will be carried out using Hybrid Hyrax appliance to compare the skeletal and dentoalveolar changes with those produced by MARPE.PERIOD OF 3 MONTHS |
| Intervention |
MARPE |
Maxillary expansion will be carried out using MARPE appliance to evaluate the skeletal and dentoalveolar changes in the maxillomandibular complex.Period of 3 months |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Subjects aged between 17 to 25 years
Subject with maxillary skeletal constriction value less than 0.8 according to YTI index
Subjects with good oral hygiene
|
|
| ExclusionCriteria |
| Details |
Patients with a previous history of orthodontic treatment
Patients with any syndromes or systemic diseases
The presence of any signs and symptoms of periodontal disease
Previous history of any surgical procedure in the maxilla
Patients with Palatal tori
Patients with impacted maxillary first premolars and molars
Patients with temporomandibular disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The following parameters will be assessed using CBCT images:
Maxillary skeletal expansion
Maxillary alveolar expansion
Mandibular alveolar expansion
Maxillary dental expansion
Mandibular dental expansion
Anteroposterior changes in the maxilla and mandible
Changes in skeletal, alveolar, and dental dimensions in the coronal plane
These parameters will be evaluated to compare the effects of MARPE and Hybrid Hyrax expanders. |
Time Points of Assessment
CBCT measurements will be recorded at two time points:
T0 (Baseline): Before maxillary expansion.
T1 (Post-treatment): 3 months after completion of maxillary expansion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in anteroposterior (axial plane) position of the maxilla and mandible following maxillary expansion using MARPE and Hybrid Hyrax appliances, assessed on CBCT. |
T0: Pre-expansion
T1: Three months post-expansion (post-expansion) |
| Change in mandibular transverse width (skeletal, alveolar, and dental levels) following maxillary expansion using MARPE and Hybrid Hyrax appliances, assessed using CBCT. |
T0: Pre-expansion
T1: Three months post-expansion |
| Comparison of pattern of expansion (skeletal versus dentoalveolar contribution) between MARPE and Hybrid Hyrax appliances using CBCT measurements. |
T0: Pre-expansion
T1: Three months post-expansion |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
27/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="30" |
|
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 study aims to compare the skeletal and dentoalveolar changes produced by two maxillary expansion appliances namely MARPE and Hybrid Hyrax in patients with transverse maxillary constriction. The study includes eighteen participants aged between twelve and seventeen years who are undergoing fixed orthodontic treatment. Participants are divided into two groups based on the type of expander used. Three dimensional CBCT images are taken before maxillary expansion and three months after completion of expansion following the retention period. Skeletal alveolar and dental changes in the maxilla and mandible are evaluated in coronal and axial planes using CBCT measurements. The results of this study will help in understanding the pattern and magnitude of changes produced by MARPE and Hybrid Hyrax appliances and assist in selecting the appropriate expansion method in adolescent patients. |