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CTRI Number  CTRI/2025/10/096338 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 16/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Link between Asthma, Mouth Breathing, and irregularly placed teeth in Children aged 5 to 14 year old visiting a hospital. 
Scientific Title of Study   Association of extrinsic asthma with mouth breathing and malocclusion among 5 to 14 year old children visiting a tertiary care hospital. 
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 Rashmi Nayak 
Designation  Professor 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Manipal College of Dental Sciences room no. 6 , 2nd floor Department of Pediatric and Preventive Dentistry , Madhav Nagar Manipal - 576104 Udupi Karnataka 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9845364987  
Fax    
Email  rashmi.nayak@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  VADDI LIKHITA 
Designation  Under graduate student 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Manipal College of Dental Sciences room no. 6 , 2nd floor Department of Pediatric and Preventive Dentistry , Madhav Nagar Manipal - 576104 Udupi Karnataka 576104 India

Udupi
KARNATAKA
576104
India 
Phone  8529147986  
Fax    
Email  vaddilikhita@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rashmi Nayak 
Designation  Professor 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Manipal College of Dental Sciences room no. 6 , 2nd floor Department of Pediatric and Preventive Dentistry , Madhav Nagar Manipal - 576104 Udupi Karnataka 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9845364987  
Fax    
Email  rashmi.nayak@manipal.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Rashmi Nayak 
Address  Manipal College of Dental Sciences, 2nd floor, room no 6 ,Manipal ,Karnataka 
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 
Dr Rashmi Nayak   Manipal College of Dental Sciences   Manipal College of Dental Sciences Room number 6 , 2nd Floor Department of Paediatric and Preventive Dentistry Madhav Nagar Manipal - 576104 Udupi Karnataka
Udupi
KARNATAKA 		 09845364987

rashmi.nayak@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 ( Student Research )  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Inclusion criteria
For study group
Children in the age group of 5-14 years
Children with known diagnosis of extrinsic bronchial Asthma.
Children with history of mouth breathing or diagnosed with mouth breathing during routine examination

For control group
Children in the age group of 5-14 years
Children with no history of extrinsic bronchial Asthma or any other chronic respiratory disorder.
Children with history of mouth breathing or diagnosed with mouth breathing during routine examination.
 
 
ExclusionCriteria 
Details  Exclusion criteria
Children with long term systemic illness
Children with physical or mental disability
Children with skeletal malocclusion
Children with harmful oral habits other than mouth breathing
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Malocclusion prevalence will be measured among patients with complaints of mouth breathing, extrinsic bronchial asthma or both. Any association among them will be explored.  Malocclusion prevalence will be measured among patients with complaints of mouth breathing,
extrinsic bronchial asthma or both. Any association among them will be explored in time period of 1 year 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="204"
Sample Size from India="204" 
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)   07/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/11/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
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   Children diagnosed with extrinsic bronchial asthma in the age group  5 to 14 years who present to the clinic with complaints of mouth breathing, malocclusion or both will be included. Healthy 5 to 14 years old children without a diagnosis of extrinsic bronchial asthma will be taken as controls.Malocclusion prevalence will be measures among patients with complaints of mouth breathing, extrinsic bronchial asthma  or both and any association among them will be explored. 
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