| CTRI Number |
CTRI/2025/05/087458 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying jaw expansion and breathing changes using mini-implants and X-rays |
|
Scientific Title of Study
|
Evaluation of changes in sutures, airway and soft tissue after mini implant assisted rapid palatal expansion (MARPE) analysed with CBCT- a 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 |
Raheesa MV Abdurahman |
| Designation |
Second year Post graduate |
| Affiliation |
YENEPOYA DENTAL COLLEGE |
| Address |
Department of Orthodontics
Yenepoya Dental College, University Road, Derlakatte, Mangalore, Dakshina Kannada, KARNATAKA, 575018, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7012113511 |
| Fax |
|
| Email |
mvraheesa114@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shafees Koya |
| Designation |
Reader |
| Affiliation |
YENEPOYA DENTAL COLLEGE |
| Address |
Department of Orthodontics
Yenepoya Dental College, University Road, Derlakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7012113511 |
| Fax |
|
| Email |
skoya@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raheesa MV Abdurahman |
| Designation |
Second year Post graduate |
| Affiliation |
YENEPOYA DENTAL COLLEGE |
| Address |
Department Of Orthodontics
Yenepoya Dental College, University Road, Derlakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7012113511 |
| Fax |
|
| Email |
mvraheesa114@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Dental College, University Road, Derlakatte, Mangalore, 575018 |
|
|
Primary Sponsor
|
| Name |
Raheesa MV Abdurahman |
| Address |
yenepoya dental college, University Road, Derlakatta, Mangalore, Karnataka, India, 575001 |
| 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 Raheesa MV Abdurahman |
Yenepoya Dental College |
Department of Orthodontics and Dentofacial Orthopaedics,
Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
7012113511
mvraheesa114@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K06||Other disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mini implant assisted rapid palatal expansion |
CBCT scans taken before expansion and after expansion .Three reference planes identified in study in order orient the skull.
MSP- maxillary sagittal plane, APP- axial palatal plane, VCP- V-coronal plane- reference planes as localized in the pre expansion CBCT and become reference line to measure the displacement of skeletal structures in post expansion CBCT. The measurements in axial palatal section (APS):
In the present study, the APS used to study split of the midpalatal and pterygopalatine sutures. The utilized landmarks are as follows that is on both the left and right side-1. ANS- anterior nasal spine 2. PNS – posterior nasal spine 3. Most Medial point of the lateral pterygoid process 4. Most Lateral point of medial pterygoid process.
The maxillary sagittal plane passes through the ANS and PNS in pre expansion CBCT and the distance between the two halves from maxillary sagittal plane in post CBCT represents lateral movement of each half.
The evaluated parameters are:
Distance of right and left ANS and PNS from maxillary sagittal plane and the width of opening in right and left pterygoid process.
CBCT scans were taken at baseline and 6 months after placement of implants |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Constricted maxillary arch
2. Treatment with MARPE as part of overall treatment
3. Patient aged early and late adolescence. |
|
| ExclusionCriteria |
| Details |
1. Presence of systemic diseases affecting orthodontic treatment.
2. Cleft palate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate magnitude of midpalatal and pterygopalatine suture opening. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evalauate airway and soft tissue changes analysed using CBCT. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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)
|
02/06/2025 |
| 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="6"
Days="3" |
|
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
Modification(s)
|
Mini Implant assisted rapid palatal expansion(MARPE) is gradually becoming the treatment of choice to correct the transverse dimensions, exceeding the limitations of conventional RME devices. One of the key factors for orthodontic diagnosis and treatment planning apart from a stable occlusion is a balanced and esthetic facial profile that is influenced by maxillary expansion. The subjects who are selected for this study with maxilla constricted patients who will be undergoing mini implant assisted rapid palatal expansion that will improve airway dimensions due to mid palatal, pterygopalatine and other circum maxillary sutures which further allows changes in facial soft tissue. As these changes are bought about by MARPE with arch expansion observed through CBCT (Cone beam Computed Tomography) which is a digital radiographic imaging technique, that produce 3-D imaging which yields better diagnostic accuracy than 2-D radiographic technique. This clinical trial study is planned with 14 participants using random sampling and designed with objective of measuring circummaxillary sutural opening, airway and facial soft tissue changes on pre treatment and post treatment CBCT. |