| CTRI Number |
CTRI/2026/03/106597 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison between different factors Of The Nasomaxillary Complex And Pharyngeal Airway Volume Between Bonded Rapid Maxillary Expansion And Micro Implant Assisted Rapid Palatal Expansion |
|
Scientific Title of Study
|
Comparative Evaluation Of Various Parameters Of The Nasomaxillary Complex And Pharyngeal Airway Volume Between Bonded Rapid Maxillary Expansion And Micro Implant Assisted Rapid Palatal Expansion 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 |
Dr Shivani Nemmaniwar |
| Designation |
PG student |
| Affiliation |
bharati vidyapeeth dental college and hospital |
| Address |
1st floor department of orthodontics and dentofacial orthopaedics bharati vidyapeeth dental college and hospital Navi Mumbai Maharastra
Thane
MAHARASHTRA
400614
India |
| Phone |
7981444490 |
| Fax |
|
| Email |
drshivaninemmaniwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parag Gangurde |
| Designation |
Head of Department |
| Affiliation |
bharati vidyapeeth dental college and hospital |
| Address |
1st floor department of orthodontics and dentofacial orthopaedics bharati vidyapeeth dental college and hospital Navi Mumbai Maharastra
Thane
MAHARASHTRA
400614
India |
| Phone |
9892580848 |
| Fax |
|
| Email |
parag.gangurde@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Nemmaniwar |
| Designation |
PG student |
| Affiliation |
bharati vidyapeeth dental college and hospital |
| Address |
1st floor department of orthodontics and dentofacial orthopaedics bharati vidyapeeth dental college and hospital Navi Mumbai Maharastra
Thane
MAHARASHTRA
400614
India |
| Phone |
7981444490 |
| Fax |
|
| Email |
drshivaninemmaniwar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shivani Nemmaniwar |
| Address |
1st floor department of orthodontics and dentofacial orthopaedics Bharati vidyapeeth dental college and hospital Navi Mumbai 400614 |
| 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 Shivani Nemmaniwar |
bharati vidyapeeth dental college and hospital |
1st floor department of orthodontics and dentofacial orthopaedics bharati vidyapeeth dental college and hospital Navi Mumbai Maharastra
Thane
MAHARASHTRA |
7981444490
drshivaninemmaniwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for biomedical and health research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bonded Rapid Maxillary Expansion |
Bonded Rapid Maxillary Expansion
will be done in 9 patients using tooth as anchorage.that will be done in growing children |
| Intervention |
Micro-Implant Assisted Rapid Palatal Expansion |
micro implant assisted RPE will be done in 9 patients using skeletal anchorage in young adults and cbct scans will be taken before and once the expansion is done in 1 month. |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group of 9 to 14 years for bonded rapid maxillary expansion.
2.Age group of 15 to 20 years for mini screw assisted rapid maxillary expansion.
3.The inclusion criteria consisted of patients with transverse discrepancy absence of any systemic diseases
4.absence of temporomandibular disorder.
5.Absence of surgical interventions such as adenoidectomy or tonsillectomy.
6.Absence of periodontal diseases systemic diseases and no active caries.
|
|
| ExclusionCriteria |
| Details |
1.Syndromic patients
2.Patients with cleft lip and palate
3.Presence of noise on the CBCT images or blurred images.
4.Patients with previous orthognathic surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the molar inclination in bonded RME and micro implant assisted RME before and after the expansion.
2.To compare the sutural opening in bonded RME and micro implant assisted RME before and after expansion.
3.To compare the pharyngeal airway volume in bonded RME and micro implant assisted RME before and after expansion.
|
CBCT evaluation will be done before the expansion and after the expansion in 2 weeks . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
06/04/2026 |
| 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) |
Open to Recruitment |
|
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
|
Maxillary transverse discrepancy is considered one of the most common orthodontic problems that could be accompanied by unilateral or bilateral posterior crossbite narrow nasal cavity and dental crowding. A common form of RME uses tooth borne expanders with bands on molars and first premolars. Transverse discrepancy is corrected through skeletal expansion ie opening of midpalatal sutures with separation of maxillary halves and dentoalveolar expansion which includes buccal tipping of teeth and alveolar bending. Many mechanically rigid fixed rapid maxillary expansion appliances have been developed to split the midpalatal suture. Hyrax expanders are known for greater hygiene and comfort with minimal interference with speech and few lesions of the palatal mucosa.With the innovation of implants a paradigm shift has occurred to the anchorage perspective and it has been possible to reinforce anchorage during rapid maxillary expansion without dental support. Miniscrews have been used as a means of absolute orthodontic anchorage. Due to the potential differences between the bone and tooth borne expanders greater changes in airway volume may be anticipated with utilization of miniscrews. The aim of the current study was to measure and compare the changes in airway volume of pharynx and naso maxillary complex changes using bonded rapid maxillary expansion and micro implant assisted rapid palatal expansion.
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