| 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 |
|
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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] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q169||Congenital malformation of ear causing impairment of hearing, unspecified, |
|
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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.
|
|
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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. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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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. |
|
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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. |
|
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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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