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CTRI Number  CTRI/2025/03/081607 [Registered on: 04/03/2025] Trial Registered Prospectively
Last Modified On: 28/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry
Behavioral 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Improving Oral Health in Hearing and Speech-Impaired Children - A Randomized Trial Comparing Education Methods 
Scientific Title of Study   Effectiveness of various education methods on oral health knowledge plaque and gingival health among hearing and speech-impaired children - A randomized controlled trial 
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 Jane Roshini R 
Designation  Postgraduate 
Affiliation  Indira Gandhi Institute of Dental Sciences  
Address  Department of Public Health Dentistry, Indira Gandhi Institute of Dental Sciences, SBV Pondicherry Campus, Pillayarkuppam, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9442405464  
Fax    
Email  janeroshini1704001017@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anusha Divvi 
Designation  Associate Professor 
Affiliation  Indira Gandhi Institute of Dental Sciences  
Address  Department of Public Health Dentistry, Indira Gandhi Institute of Dental Sciences, SBV Pondicherry Campus, Pillayarkuppam, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  8331849330  
Fax    
Email  anusha@igids.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Anusha Divvi 
Designation  Associate Professor 
Affiliation  Indira Gandhi Institute of Dental Sciences  
Address  Department of Public Health Dentistry, Indira Gandhi Institute of Dental Sciences, SBV Pondicherry Campus, Pillayarkuppam, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  8331849330  
Fax    
Email  anusha@igids.ac.in  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Dental Sciences, SBV Pondicherry Campus, Pillayarkuppam, Pondichery - 607402 
 
Primary Sponsor  
Name  Dr Jane Roshini R 
Address  Indira Gandhi Institute of Dental Sciences, SBV Pondicherry Campus, Pillayarkuppam, Pondicherry - 607402 
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 Jane Roshini R  Shri Patcheappane School for the Hearing Impaired  Shri Patcheappane School for the Hearing Impaired, Nehru nagar, Thengaithittu, Puducherry - 605004
Pondicherry
PONDICHERRY 		 9442405464

janeroshini1704001017@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Indira Gandhi 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: H908||Mixed conductive and sensorineuralhearing loss, unspecified, (2) ICD-10 Condition: J383||Other diseases of vocal cords, (3) ICD-10 Condition: K056||Periodontal disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A - DIY kit intervention on oral health education   DIY kit intervention- The study subjects will be given DIY kit which contains three activity based oral hygiene education on toothbrushing, diet, and how plaque affects oral health through an experiment. The children will be given the instructions of the activity through the sign language. The intervention will be given by the primary investigator along with class teacher. Total Duration of this Intervention is 1 day. 
Comparator Agent  Group B - Visual guided oral health education  A visual aid based oral hygiene education will be played. The visual aid contains oral hygiene education on brushing technique, diet and about how plaque affects the tooth. A video on oral health maintenance will be prepared using sign language with the help of an Indian sign language instructor. The content of the video will be validated. Total duration of this intervention is 1 day. 
Comparator Agent  Group C - Caregiver guided oral health education  The Caregiver will be given oral hygiene education through pamphlet. And the caregiver needs to educate the children on oral hygiene education Total duration of this intervention is 1 day. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Study subjects aged 6- 10 years in the mixed dentition.
Study subjects having Hearing and Speech Impaired[ Disabling
hearing loss refers to hearing loss greater than 35 decibels (dB) in the better
hearing ear].
Study subjects being part of psychosocial support groups under the
supervision of a trained monitor.
Study subjects with plaque-induced gingivitis.
Study subjects with plaque index score – 0.1-0.9 and gingival index score - mild gingivitis after the washout period of 14 days.

 
 
ExclusionCriteria 
Details  Subjects suffering from systemic conditions and chronic debilitating
conditions like Epilepsy, Down syndrome, etc., and/or on long term
medications which could influence their oral status.
Subjects with history of receiving antibiotic and/or antiseptic therapy.
Subjects who are not willing to participate and did not give informed
consent and assent.
Subjects with periodontal disease will be eliminated.
Subjects undergoing fixed orthodontic therapy.
Subjects with physical disabilities, impaired motor functions, non-compliant behavior, etc 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
effectiveness of DIY kit intervention of oral hygiene education with
visual and caregiver guided education methods among hearing and speech impaired
children 		 28 Days 
 
Secondary Outcome  
Outcome  TimePoints 
effectiveness of DIY kit intervention of oral hygiene education using
oral health literacy scale  		 Immediately after Intervention 
effectiveness of DIY kit intervention of oral hygiene education using
oral health literacy scale, Plaque and gingival scores 		 One Week, 15 days, 28 days 
effectiveness of Visual guided oral hygiene education using oral health
literacy scale 		 Immediately after Intervention 
effectiveness of Visual guided oral hygiene education using Oral health literacy scale, Plaque and gingival Scores  one week, 15 days and 28 days 
effectiveness of Caregiver guided oral hygiene education using oral
health literacy scale 		 Immediately after Intervention 
effectiveness of Caregiver guided oral hygiene education using Oral health literacy scale, Plaque and gingival Scores  one week, 15 days and 28 days 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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 2 
Date of First Enrollment (India)   17/03/2025 
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="0"
Months="0"
Days="28" 
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   AIM: To compare the effectiveness of DIY kit intervention of oral hygiene education with visual and caregiver guided education methods among hearing and speech impaired children.

STUDY POPULATION : Hearing and Speech impaired children

RESEARCH QUESTION: Is there any difference in the effectiveness of DIY kit intervention in comparison with visual and caregiver-guided oral health education methods on oral health knowledge, plaque and gingival health among hearing and speech-impaired children?

SAMPLING PROCEDURE: The study subjects will be randomly allocated into three study groups using cluster randomization.

STUDY GROUPS:
  The number of groups is 3. 
• Group A – (n=18) – DIY kit intervention on oral health education
• Group B – (n=18) – Visual guided education method 
 â€¢ Group C – (n=18) – Caregiver guided education method 

SAMPLE SIZE :
The sample size was calculated using G power software version 3.1. The calculation was based on the mean Plaque scores among children with hearing and speech impaired from a previous study conducted by Maria Moin et al (2021) (). With 95% power and alpha error 5%, the minimum sample size was calculated to be 48, n=16 in each group. (ANNEXURE 1). Anticipating a 10% loss to follow up, the sample size is calculated as 18 per group (n=18). Thus, the total sample size N=54

METHODOLOGY : 
The study subjects will be selected based on the inclusion criteria and exclusion criteria. The study subjects will be randomly allocated into 3 groups namely Group A, B and C with each group containing 18 participants.
At baseline, Knowledge will be assessed with a newly designed oral health literacy scale which will be assessed for its validity and reliability before beginning the study. The number of correct answers will be summed which gives the score of the newly developed scale. As the score increases, the knowledge increases. Oral Examination: The plaque scores will be assessed using Silness J and Loe H Plaque Index, 1967.  The gingival scores will be assessed using Loe H & Silness J Gingival Index, 1963. 

Interventions for Group A: 

DIY kit intervention: 

• The study subjects will be given DIY kit which contains three activity based oral hygiene education on toothbrushing, diet, and how plaque affects oral health through an experiment. 
• The children will be given the instructions of the activity through the sign language. 
• The intervention will be given by the primary investigator along with class teacher.

 Interventions for Group B: 

Visual guided education: 

• A visual aid based oral hygiene education will be played.
 â€¢ The visual aid contains oral hygiene education on brushing technique, diet and about how plaque affects the tooth. 
• A video on oral health maintenance will be prepared using sign language with the help of an Indian sign language instructor. 
The content of the video will be validated.
 Interventions for Group C: 

 Caregiver guided education:

 â€¢ The Caregiver will be given oral hygiene education through pamphlet. 
• And the caregiver needs to educate the children on oral hygiene education.

 All the subjects will be provided with an oral hygiene kit containing a soft bristled toothbrush and fluoridated toothpaste during the study.

 Follow up: 
Knowledge assessment will be carried out using oral health literacy scale in the three study groups immediately, one week, 15 days and 28 days after intervention. Plaque and gingival index will be assessed on 15th day and 28th day after intervention.


 
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