| 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
|
|
|
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
|
|
|
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
|
|
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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.
|
|
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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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