| 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
|
|
|
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
|
|
|
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. |