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CTRI Number  CTRI/2025/07/090159 [Registered on: 03/07/2025] Trial Registered Prospectively
Last Modified On: 26/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Investigating Lower Jaw Differences in Asthmatic Children Through X-rays 
Scientific Title of Study   Orthopantomographic analysis for assessment of mandibular asymmetry in asthmatic children : An In-Vivo 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 Shradha Akolkar 
Designation  Post Graduate Student 
Affiliation  Bhararti Vidyapeeth Deemed to be University dental college and hospital 
Address  Bharati Vidyapeeth (deemed to be university) dental college and hospital, Pune – Satara Road, Katraj - Ambegaon BK Rd, Dhankawadi, Pune, Maharashtra 411043

Pune
MAHARASHTRA
411043
India 
Phone  9515965008  
Fax    
Email  shradhaakolkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shweta chaudhary 
Designation  Assistant professor and Post graduate guide 
Affiliation  Bhararti Vidyapeeth Deemed to be University dental college and hospital 
Address  Bharati Vidyapeeth (deemed to be university) dental college and hospital, Pune – Satara Road, Katraj - Ambegaon BK Rd, Dhankawadi, Pune, Maharashtra 411043

Pune
MAHARASHTRA
411043
India 
Phone  9665113526  
Fax    
Email  shweta.chaudhary@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Shradha Akolkar 
Designation  Post Graduate Student 
Affiliation  Bhararti Vidyapeeth Deemed to be University dental college and hospital 
Address  Bharati Vidyapeeth (deemed to be university) dental college and hospital, Pune – Satara Road, Katraj - Ambegaon BK Rd, Dhankawadi, Pune, Maharashtra 411043

Pune
MAHARASHTRA
411043
India 
Phone  9515965008  
Fax    
Email  shradhaakolkar@gmail.com  
 
Source of Monetary or Material Support  
Bhararti Vidyapeeth Deemed to be University dental college and hospital,Pune – Satara Road, Katraj - Ambegaon BK Rd, Dhankawadi, Pune, Maharashtra 411043 
 
Primary Sponsor  
Name  Bhararti Vidyapeeth Deemed to be University dental college and hospital 
Address  Pune – Satara Road, Katraj - Ambegaon BK Rd, Dhankawadi, Pune, Maharashtra 411043 
Type of Sponsor  Private medical college 
 
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 
DrShradha Akolkar  Bharati vidyapeeth(Deemed to be university) dental college and hospital  Room number - 208, second floor dental wing, Pune – Satara Road, Katraj - Ambegaon BK Rd, Dhankawadi, Pune, Maharashtra 411043
Pune
MAHARASHTRA 
9515965008

shradhaakolkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati vidyapeeth (deemed to be unniversity)pune india dental college and hospital , pune instituitional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J453||Mild persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Children between age 6-12 years will be selected for the study
2.The children with a diagnosis of asthma.
3.The child should not have had previous orthodontic treatment or any abnormal oral habits; children without any abnormal physical growth;
 
 
ExclusionCriteria 
Details  1. Children or his/her parents refused to participate in the study
2.Children with retrognathia or who require a rapid intervention by a physician’s unit were excluded
3.Children with other diseases such as diabetes, blood dyscrasias ,growth hormone deficiency etc


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcome attained after the measurement using cephalometric mandibular analysis would be measured and compared between the two groups which is asthmatic and non asthmatic children for early diagnosis and immediate intervention .   outcome will be assessed at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
nil  not applicable 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   19/07/2025 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

The development of an individual’s facial shape and structure is influenced by a combination of genetic factors and environmental influences, such as their intensity and duration ( Paternoster et al., 2012). Changes in breathing mechanics can impact the development of craniofacial structures ( Yamada et al., 1997) and disrupt normal functions like chewing and swallowing, which are crucial for balanced facial growth (Moss, 1962). Nasopharyngeal blockage often leads to mouth-breathing (Straub, 1994), prompting compensatory changes in head posture to accommodate reduced nasal airflow (Josell, 1995). These adjustments can lead to disharmony in the growth and development of orofacial structures (Rubin, 1980).

Several systemic medical conditions, including type 1 diabetes (El-Bialy et al., 2000), growth hormone deficiency (Kjellberg et al., 2000), and asthma (Richmond et al., 2009), can also affect facial morphology.

 Chronic asthma, characterized by increased airway resistance and chest gas-trapping (Chaves et al., 2010), alters the mechanics of breathing, potentially shortening cervical respiratory muscles and influencing head and cervical spine posture ( Lopes et al., 2007). This dysregulation may contribute to maxillary narrowing and reduced mandibular development ( Solow and Sandham, 2002) among patients with asthma symptoms.

Hence based on the above said reports,this study helps in evaluating any mandibular asymmetries through OPG, (A simple tool) during the developmental and growth stages of asthmatic children and be valuable in diagnosing and early intervention of the asymmetry.

 
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