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CTRI Number  CTRI/2025/01/079377 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive
Screening
Dentistry
Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Oral Hygiene Status and Malocclusions in Children with Speech, Hearing and Visual Impairments.  
Scientific Title of Study   Association of Malocclusion with Oral Hygiene Status in children with speech, hearing and visual impairments: an interventional 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  Pratyasha Sharma 
Designation  Post graduate student 
Affiliation  AB Shetty Memorial Institute of Dental Sciences 
Address  Room no. 15, Department of Pediatric and Preventive Dentistry, Fourth Floor, AB Shetty Memorial Institute of Dental Sciences, Dakshina Kannada District, Karnataka.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9101373663  
Fax    
Email  pratyasha83@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof (Dr.) Srikala Bhandary 
Designation  Additional Professor 
Affiliation  AB Shetty Memorial Institute of Dental Sciences 
Address  Room no. 15, Department of Pediatric and Preventive Dentistry, Fourth Floor, AB Shetty Memorial Institute of Dental Sciences, Dakshina Kannada District, Karnataka.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9535620371  
Fax    
Email  drsrikalabhandary@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Pratyasha Sharma 
Designation  Post graduate student 
Affiliation  AB Shetty Memorial Institute of Dental Sciences 
Address  Room no. 15, Department of Pediatric and Preventive Dentistry, Fourth Floor, AB Shetty Memorial Institute of Dental Sciences, Dakshina Kannada District, Karnataka.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9101373663  
Fax    
Email  pratyasha83@gmail.com  
 
Source of Monetary or Material Support  
Room no. 15, Department of Pediatric and Preventive Dentistry, Fourth Floor, AB Shetty Memorial Institute of Dental Sciences, Dakshina Kannada District, Karnataka - 575018 
 
Primary Sponsor  
Name  Pratyasha Sharma 
Address  Room no. 15, Department of Pediatric and Preventive Dentistry, Fourth Floor, AB Shetty Memorial Institute of Dental Sciences, Dakshina Kannada District, Karnataka. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pratyasha Sharma  AB Shetty Memorial Institute of Dental Sciences  Room no. 15, Department of Pediatric and Preventive Dentistry, Fourth Floor, AB Shetty Memorial Institute of Dental Sciences, Dakshina Kannada District, Karnataka.
Dakshina Kannada
KARNATAKA 
09101373663

pratyasha83@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AB Shetty Memorial Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q169||Congenital malformation of ear causing impairment of hearing, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable  
Intervention  Screening, Diagnosis of Malocclusions, Oral prophylaxis, Pit and fissure sealants placement, Fluoride application.  1. Oral prophylaxis 2. Pit and fissure sealants. 3. Fluoride application Interventions will be done at baseline and after 3 months, if required.  
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Children aged 8-14 years with speech, hearing, and/or visual impairments.  
 
ExclusionCriteria 
Details  Children aged 8-14 years with speech, hearing and visual impairments who have undergone or are undergoing orthodontic treatment.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the association of malocclusion with oral hygiene status in children with speech, hearing and visual impairments.  At Baseline - To determine the prevalence and type of malocclusion in children with speech, hearing and/or visual impairments.  
 
Secondary Outcome  
Outcome  TimePoints 
1)To clinically examine the extraoral and intraoral features of children with speech, hearing and visual impairments, for traits of malocclusion.
2)To assess the distribution of different malocclusion traits in children with speech, hearing and visual impairments.
3)To assess the oral hygiene status of the children with malocclusion before and after oral prophylaxis and oral health education.
4)To find the association between malocclusion and oral hygiene status.
 
Baseline - Assessment of Oral Hygiene Status.
At 3 months post intervention - Assessment of Oral Hygiene Status.  
 
Target Sample Size   Total Sample Size="382"
Sample Size from India="382" 
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   Phase 4 
Date of First Enrollment (India)   17/02/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
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  

Aim:

To evaluate the association of malocclusion with oral hygiene status in children with speech, hearing and visual impairments.

 

Objectives:

1)    To clinically examine the extraoral and intraoral features of children with speech, hearing and visual impairments, for traits of malocclusion.

2)    To assess the distribution of different malocclusion traits in children with speech, hearing and visual impairments.

3)    To assess the oral hygiene status of the children with malocclusion before and after oral prophylaxis and oral health education.

4)    To find the association between malocclusion and oral hygiene status.


Source of data:

1)    Children between the ages of 8-14 years diagnosed with speech, hearing and visual impairments.

2) The school authorities of the special schools will be approached for obtaining consent to conduct dental screening and oral health program at tbeir centers and enrolling the students as participants in this study. 

3)    Informed consent will be obtained from the parents/caregivers of the children prior to the study. Assent shall be obtained from the participating children.

4)    Ethical clearance will be obtained from the Institutional Ethics Committee, ABSMIDS, NITTE (Deemed to be University).

METHODS OF COLLECTION OF DATA:

1. Children between the ages of 8-14 years who have been diagnosed with speech, hearing or visual impairments, will be included in the study.

2. The parents/caregivers’ level of interest and awareness towards the oral health problems associated with malocclusion will be assessed through a brief, unstructured, and an informal interview.

3.  A brief dental and medical history of the participating children will be taken by the examiner.

4. The participating children will be visually and clinically examined for the following malocclusion traits after taking informed consent from the parents/caregivers and assent from the children:

Extraoral Assessment:  Head Shape, Face Shape, Facial Profile, Facial Symmetry and Lip Competency.

Intraoral Assessment: Teeth present (FDI numbering system); Interarch measurements such as Anteroposterior molar relationship (Angle’s classification); Vertical relationship (overjet and overbite); Presence of diastema, crowding or rotated teeth; Incidence of Traumatic Dental Injuries; Presence of any oral habits that may affect the occlusion. 

5. The oral hygiene status of the participating children with malocclusion will be assessed with the Simplified Oral Hygiene Index (Green and Vermillion, 1964).

6. Oral prophylaxis will be done, oral health education will be given by the examiner, and proper tooth brushing techniques will be taught to the participating children.

7. After 3 months, a follow up will be done and the oral hygiene status of the participating children will be reassessed with the Simplified Oral Hygiene Index (Green and Vermillion, 1964).



 
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