| CTRI Number |
CTRI/2024/07/069755 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation of mouth breathing with oral health related quality of life in 6 to 13 year old children a cross sectional study |
|
Scientific Title of Study
|
Association of mouth breathing with oral health related quality of life in six to thirteen year old children a cross sectional 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 |
Mansi Mahesh Mangela |
| Designation |
PG Student |
| Affiliation |
Y. M .T Dental college and Hospital, Kharghar , navimumbai |
| Address |
Room no 21 department of Pediatric and Preventive dentistry , Y. M. T Dental college and Hospital , Sector 4 Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9665005665 |
| Fax |
|
| Email |
mansimangela@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amar Katre |
| Designation |
Professor |
| Affiliation |
Y. M .T Dental college and Hospital, Kharghar , navimumbai |
| Address |
Room no 21, Department of Pediatric and Preventive Dentistry , Y M T Dental college and Hospital, Sector 4, Kharghar , navimumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
|
| Fax |
|
| Email |
amar_katre@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mansi Mahesh Mangela |
| Designation |
PG Student |
| Affiliation |
Y .M .T Dental college and Hospital, Kharghar , navimumbai |
| Address |
Room no.21, department of pediatric and preventive dentistry, Y M T Dental college and Hospital, Sector 4 , Kharghar , navimumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
|
| Fax |
|
| Email |
mansimangela@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Mansi Mangela
Jivdani Darshan bunglow, mangela aali, naringi village , near naringi cricket ground ,virar west 401303 , Maharashtra ,India |
|
|
Primary Sponsor
|
| Name |
Dr Mansi Mangela |
| Address |
Jivdani darshan bunglow, mangela aali, naringi village, near naringi cricket ground, virar west, 401303, maharashtra, india |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 |
| Dr Mansi Mangela |
Y.M.T Dental college and Hospital , Kharghar , Navimumbai |
Department of pediatric
and preventive dentistry,YMT Dental College and Hospital,
Institutional area,Sector
4,Kharghar, Navimumbai - 410210
Raigarh
MAHARASHTRA |
9665005665
mansimangela@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, YMT Dental college and hospital, Kharghar, Navimumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children between six to thirteen years of age and their parents. |
|
| ExclusionCriteria |
| Details |
1. Children who are physically or mentally challenged and/or medically compromised.
2. Children with known History asthma or suffering from acute URTI
3. Children whose general condition interferes with examination and data collection.
4. Children undergoing or completed orthodontic treatment.
5. Children whose parents refuse to give consent |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess prevalence of mouth breathing
2. To assess the OHRQoL (using COHIP) in six- to thirteen-year-old children with nasal and mouth breathing
3. To compare the OHRQoL between six- to thirteen-year-old children with nasal and mouth breathing. |
At baseline only, no further recall |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the prevalence of tonsillar hypertrophy using Brodsky’s criteria
2. To assess the inter-canine and inter-molar width in children with mouth breathing.
3. To assess the association of tonsillar hypertrophy and OHRQoL
4. To assess the association of mouth breathing and inter-canine and inter-molar width |
At baseline only, no further recall |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
Final Enrollment numbers achieved (Total)= "213"
Final Enrollment numbers achieved (India)="213" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
30/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/01/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Based on the results of the current study, we conclude that Mouth breathing (MB) is associated with poor OHRQoL in 6 to 13year old children.The following objective specific conclusions can be drawn from the study: 1. Prevalence of MB was 47.89% in the study population. 2. The COHIP domain scores and total score showed moderate variability among participants, indicating differences in oral health-related quality of life within the study population. 3. Nasal breathing is associated with better oral health-related quality of life, whereas mouth breathing is associated with a negative impact on OHHRQoL. 4. Prevalence of abnormal tonsillar size was 50.23% in six- to thirteen-year-old children. 5. Children with nasal breathing showed slightly greater maxillary inter-canine width, the difference was not statistically significant in the study population. 6. There was no significant difference in mandibular inter-canine width between nasal and mouth breathing children in the study population. 7. Children with nasal breathing had significantly greater maxillary inter-molar width compared to mouth breathing in the study population. 8. There was no statistically significant difference in mandibular inter-molar width between nasal and mouth breathing children in the study population. 9. Children with a mouth-breathing were significantly more likely to present with a Class II molar relationship compared to nasal breathing children in the study population. 10. Mouth breathing is associated with an increased prevalence of crossbite. 11. Mouth breathing may have a stronger relationship with transverse discrepancies than with vertical malocclusions in the present study population. 12. Decrease in OHRQoL with increasing overjet in the present study population. 13. Increase in overbite was associated with higher COHIP total scores in the study population. 14. Overall, the findings indicate that occlusal parameters (overjet and overbite), breathing pattern, and tonsil visibility were significantly associated with COHIP total scores, whereas age and sex did not have a statistically significant relationship.
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