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CTRI Number  CTRI/2021/06/034412 [Registered on: 28/06/2021] Trial Registered Prospectively
Last Modified On: 01/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To measure jaws changes associated with mouth breathing children. 
Scientific Title of Study   Assessing the maxillary and mandibular dimensions in children exhibiting mouth breathing habit. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr J Sri Bhavya 
Designation  Post graduate student 
Affiliation  SIBAR institute of Dental Sciences, Takkellapadu 
Address  Room No. 7, Second Floor, Department of Pediatric Dentistry, SIBAR institute of Dental Sciences, Takkellapadu, Guntur.

Guntur
ANDHRA PRADESH
522509
India 
Phone  9550255820  
Fax  08632292139  
Email  sribhavya6646@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr A J Sai Sankar 
Designation  Professor & Head  
Affiliation  SIBAR institute of Dental Sciences, Takkellapadu 
Address  Room No. 7, Second Floor, Department of Pediatric Dentistry, SIBAR institute of Dental Sciences, Takkellapadu, Guntur.

Guntur
ANDHRA PRADESH
522509
India 
Phone  9346550646  
Fax  08632292139  
Email  saisamata@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vivekanand Kattimani 
Designation  Professor & Head  
Affiliation  SIBAR institute of Dental Sciences, Takkellapadu 
Address  Department of Clinical Research SIBAR institute of Dental Sciences, Takkellapadu, Guntur.

Guntur
ANDHRA PRADESH
522509
India 
Phone  9492473628  
Fax  08632292139  
Email  DRVIVEKANANDSK@GMAIL.COM  
 
Source of Monetary or Material Support  
Dean, Ground Floor, Office Block, Sibar institute of Dental sciences, Guntur Andhra Pradesh.  
 
Primary Sponsor  
Name  Dr L Krishna Prasad 
Address  Dean,SIBAR institute of Dental Sciences, Takkellapadu, Guntur. Andhra Pradesh, India 522509.  
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 
J Sri Bhavya  Sibar Institute of Dental Sciences Guntur  Room no- 7, Second floor , Department of Pediatric dentistry Guntur
Guntur
ANDHRA PRADESH 
9550255820
08632292139
sribhavya6646@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Sibar Institute of Dental Sciences Guntur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Nasal breathers 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1.Children exhibiting normal respiratory mode without any malocclusion.
2.Children with fully erupted primary and/ or permanent teeth
 
 
ExclusionCriteria 
Details  1.Children with history of oral and maxillofacial surgeries.
2.Traumatic injuries to jaws.
3.Abnormalities effecting growth and development.
4.Previous history of nasal respiratory surgery.
5.Cleft lip & cleft palate.
6.Other genetic diseases.
7.Children with unerupted or partially erupted teeth, and over-retained teeth.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in measurements of:
1. Increased palatal height
2. Increased over jet.
3. Reduced overbite
4. Reduced maxillary intermolar width.
5. Reduced mandibular intermolar width. 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Number of patients taking targeted intervention.  4 weeks 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   01/07/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NOT YET PUBLISHED  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The development of occlusion is an interplay between genetically determined developmental factors along with environmental and few external and internal factors related to orofacial function. McLoughlin and Hanson reviewed the current and historical information on myofunctional factors such as negative oral habits, mouth breathing, lingual rest, swallowing patterns, and other behaviors that have been shown to affect dentition and facial growth. The environmental factor most widely viewed as influential in the development of dentofacial anomalies is the “open mouth posture” associated with mouth breathing.

Nasal breathing, which is inherent to human beings, has an important role in preparing the air to reach the greater structures of the respiratory system, stimulates adequate growth of the craniofacial complex, with a direct influence on the development of the jawbones, posture of the jaw, positioning of the tongue, and maintenance of the rhino pharyngeal space. Any factor that interferes with the upper airway may partially or completely substitute nasal breathing with mouth breathing, and the persistence of this can lead to muscle imbalance. Imbalances in these forces causes repercussion on craniofacial structures and the stomatognathic system in the form of  reduction in nasal patency, and maxillary atresia. The result would be open-mouth posture, a nose that appears to be flattened, nostrils that are small and poorly developed, a short upper lip, and a fuller lower lip. Studies have shown that these individuals  display retroclined incisors, a narrow V-shaped upper jaw with a high palatal vault, a class II skeletal relationship or a posterior cross-bite, and a reduced overbite. It has been argued that these morphological alterations are a result of transformed activity of specific facial muscles related to mouth breathing. Gottlieb recommends further studies and attention to the role of muscles and airway in the cause and course of the treatment. In view of this, a careful anatomical examination is indispensable. Therefore, the size of the dental arches during the deciduous and mixed dentition period becomes potentially crucial in determining the correct tooth alignment. As it is a common clinical condition, one should recognize the need for awareness of parents, teachers, and professionals about the systemic impact of improper breathing mode and the compromised quality of life in these patients. The comprehensive knowledge on habit related structural variations in maxilla and mandible helps the clinician in planning early and targeted intervention and thus, timely interception and precise correction of muscular and dentofacial habit related deviations become possible. Therefore, this current study aims to assess the possible dimensional variations in the maxillary and mandibular arches in children exhibiting mouth breathing habit.

 

 
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