| CTRI Number |
CTRI/2024/06/069422 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between tongue position and body posture and its influence on childrens teeth malalignment |
|
Scientific Title of Study
|
Correlation of Body Posture with tongue position and its influence on developing dental malocclusion in children: An observational 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 Mrunali Deshkar |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pediatric and Preventive dentistry, Sharad Pawar Dental College and hospital, sawangi, wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9403173738 |
| Fax |
|
| Email |
mrunalideshkar123@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nilima Thosar |
| Designation |
Professor and head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pediatric and Preventive dentistry, Sharad Pawar Dental College and hospital, sawangi, wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9284522620 |
| Fax |
|
| Email |
drnthosar@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nilima Thosar |
| Designation |
Professor and head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pediatric and Preventive dentistry, Sharad Pawar Dental College and hospital, sawangi, wardha
MAHARASHTRA 442001 India |
| Phone |
9284522620 |
| Fax |
|
| Email |
drnthosar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Wardha , India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research, Wardha , India 442001 |
| Address |
Sawangi Meghe, Wardha , India 442001 |
| 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 |
| Dr Mrunali Deshkar |
Sharad Pawar Dental College and Hospital |
Department of Pediatric and Preventive Dentistry, third floor,SPDC building, Sawangi Meghe,442001 Wardha MAHARASHTRA |
9403173738
mrunalideshkar123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K009||Disorder of tooth development, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
The inclusion criteria pertain to children aged 6 to 12 years exhibiting tongue thrust. |
|
| ExclusionCriteria |
| Details |
Those with a history of upper or lower limb surgery, patients with history of hospitalization/intubation, severe trauma that altered their baseline posture, prior orthodontic treatment, systemic diseases, or a refusal to participate in follow-up visits and assessments (parents and children) will be excluded from this study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between postural changes and tongue position and its influence on developing dental malocclusion. |
Assessment will be done at 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
25/07/2024 |
| 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="2" Months="0" 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
|
Tongue posture plays a
crucial role in oral function and craniofacial development. A habitual tongue
thrust or low tongue posture at rest can exert pressure on the teeth, leading
to dental crowding, open bites, or other malocclusions.
Sustaining general
musculoskeletal health requires maintaining proper body posture. The mandible’s
position and the tongue’s resting place can both be impacted by poor body
posture, such as forward head posture. These alterations may, in turn, impact the development of
dental malocclusion by exerting abnormal forces on the teeth and supporting
structures. The relationship between tongue position and dental occlusion is complex and
multifactorial, involving neuromuscular coordination and oral habits developed
during childhood.
Need of the study- By evaluating how
postural deviations and tongue position impact children’s dental occlusion and
craniofacial development, the current study can offer early interventions and
preventive measures intended at encouraging optimal oral health outcomes.
Aim- To evaluate the
correlation between body posture with tongue position
and its influence on developing dental malocclusion in pediatric patients.
Materials
and methods- This study will be
conducted in Department of Paediatric and Preventive Dentistry at Sharad Pawar
Dental College, Wardha, Maharashtra, India. Children who exhibit tongue thrust between
the age range of 6 and 12 will be included in the study. Those with a history
of upper or lower limb surgery, patients with history of hospitalization/intubation,
severe trauma that altered their baseline posture, prior orthodontic treatment,
systemic diseases, or a refusal to participate in follow-up visits and
assessments (parents and children) will be excluded from this study. The participants
will undergo evaluation for abnormal tongue position, and an analysis will be
done based on the New York Posture Rating Scale and Foot Posture Index. The
Chi-square test and correlation analysis will be used for statistical analysis. |