CTRI Number |
CTRI/2020/04/024600 [Registered on: 13/04/2020] Trial Registered Prospectively |
Last Modified On: |
31/03/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Non-randomized, Active Controlled Trial |
Public Title of Study
|
Evaluation of Effects of Arch Expansion on Tongue Posture and Nasal Volume in patients with Mouth breathing habit – A Radiological study. |
Scientific Title of Study
|
Evaluation of Treatment Effects of Rapid Maxillary Expansion on Tongue Posture and Nasomaxillary Complex In Mouth Breathers – A CBCT study. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Niyati Mehta |
Designation |
Post-graduate student |
Affiliation |
Government Dental college and hospital, Nagpur |
Address |
101, PG section, Department of Orthodontics and Dentofacial Orthopedics,Government dental college and hospital, Medical square, Nagpur
Nagpur MAHARASHTRA 440003 India |
Phone |
7821883795 |
Fax |
|
Email |
niyati.mehta31@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Niyati Mehta |
Designation |
Post-graduate student |
Affiliation |
Government Dental college and hospital, Nagpur |
Address |
101, PG section, Department of Orthodontics and Dentofacial Orthopedics,Government dental college and hospital, Medical square, Nagpur
Nagpur MAHARASHTRA 440003 India |
Phone |
7821883795 |
Fax |
|
Email |
niyati.mehta31@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Santosh J Chavan |
Designation |
Associate Professor and Guide |
Affiliation |
Government Dental college and hospital, Nagpur |
Address |
101, PG section, Department of Orthodontics and Dentofacial Orthopedics,Government Dental college and Hospital, Medical square, Nagpur
Nagpur MAHARASHTRA 440003 India |
Phone |
9823630486 |
Fax |
|
Email |
drsjchavan@gmail.com |
|
Source of Monetary or Material Support
|
Dr Niyati Mehta, Post-graduate student, Department of Orthodontics and Dentofacial Orthopedics, Government Dental College and Hospital, Nagpur, Maharashtra, 440003 |
|
Primary Sponsor
|
Name |
Niyati Mehta |
Address |
101, PG section, Department of Orthodontics and Dentofacial Orthopedics, Government Dental College and Hospital, Medical square, Nagpur 440003 |
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 |
Niyati Mehta |
Government Dental College and Hospital, Nagpur |
101, PG section, Department of Orthodontics and Dentofacial Orthopedics, Government Dental College and Hospital, Medical Square, Nagpur 440003 Nagpur MAHARASHTRA |
7821883795
niyati.mehta31@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, GDCH Nagpur |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Not applicable |
Not applicable |
Intervention |
Rapid maxillary expansion |
Type of expansion which along with increasing maxillary width, it enhances nasal breathing by increasing the volume of the nasomaxillary complex |
|
Inclusion Criteria
|
Age From |
10.00 Year(s) |
Age To |
14.00 Year(s) |
Gender |
Both |
Details |
1) Growing patients with a mean age of 10-14 years
2) Constricted maxilla with or without posterior crossbite
3) Mouth breathing habit. |
|
ExclusionCriteria |
Details |
1) Any previous tonsillar, nasal, adenoid, head or neck surgery.
2) Any craniofacial syndrome or deformity.
3) Previous orthodontic treatment
4) Patients with any sign of fluid accumulation in the maxillary sinus CBCT image. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Improvement in the tongue posture and increase in the nasal, nasopharyngeal, oropharyngeal and maxillary sinus volumes will be measured on a 3D software Romexis viewer on the post -CBCT scan and compared with the pre-treatment values of
the pre-CBCT scan |
The outcome will be assessed after 12 weeks ( 3 months ) |
|
Secondary Outcome
|
Outcome |
TimePoints |
Increase in maxillary arch width and alveolar bone bending to be assessed. |
It will be assessed after 12 weeks ( 3 months) |
|
Target Sample Size
|
Total Sample Size="26" Sample Size from India="26"
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)
|
20/04/2020 |
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="1" Months="6" Days="2" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Transverse maxillary deficiency associated with respiratory problems is a condition frequently seen in orthodontic practice. Maxillary constriction is commonly associated with unilateral or bilateral posterior crossbite, anterior dental crowding, high palatal vault, lowered tongue posture, and a compromised airway. Nasal breathing allows adequate growth and development of the craniofacial complex. In contrast, nasal obstruction that leads to mouth breathing results in a lower tongue posture and a constricted ‘V’ shaped maxillary arch. Rapid maxillary expansion (RME), first introduced by Emerson C. Angell in 1860, is a well-documented dentofacial orthopedic treatment procedure for correcting transverse maxillary deficiency which has been routinely used in young patients. The main goal of RME is to correct the existing posterior crossbite and to widen the maxilla and increase the maxillary dental arch length. However, a concomitant and contributing benefit of this procedure is an improvement in the upper airway which facilitates nasal respiration. RME brings about not only an increase in nasal airway dimensions but also decreases naso-respiratory problems by anteriorly positioning the tongue in the oral cavity, improving its posture, in patients with maxillary constriction and mouth breathing. Most investigators have analyzed the effects of RME through two dimensional radiographic techniques including lateral cephalograms and posteroanterior cephalograms. Recent advances in cone beam computed tomography (CBCT) and related software have made it possible to visualize and measure the upper airway as a solid structure. Lower costs, lower radiation dose, shorter scanning time, and overall accuracy have made CBCT technology a preferred method to assess the airway. The purpose of this study is to assess changes in tongue posture and volume of nasomaxillary complex in patients with transverse maxillary deficiency associated with mouth breathing after Rapid Maxillary Expansion (RME) using CBCT. At the same time, increase in maxillary arch width and alveolar bending will also be assessed. |