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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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