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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  
Name  Address 
NIL  NA 
 
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  
Status 
Not Applicable 
 
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.

 
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