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CTRI Number  CTRI/2024/12/078830 [Registered on: 31/12/2024] Trial Registered Prospectively
Last Modified On: 26/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparing acceptance of music tooth brush with normal tooth brush in cleaning among children with Autism  
Scientific Title of Study   Acceptance and efficacy of music augmented manual tooth brush in plaque removal among children with autism spectrum disorder- A Randomiziesd 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 P Sharvari Aithal 
Designation  PG Student 
Affiliation  KVG Dental College and Hospital 
Address  Room no 10 department of pediatric and preventive dentistry KVG Dental College and Hospital Sullia dakshina kannada karnataka India 574327 Dakshina Kannada KARNATAKA 574327 India

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9844916037  
Fax    
Email  sharvari.aithal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Savitha N S 
Designation  Professor and Head of the department of pediatric and preventive dentistry 
Affiliation  KVG Dental College and Hospital 
Address  Room no 10 Department of Pediatric and Preventive dentistry KVG Dental College and Hospital Kurunjibhag Sullia D K Karnataka India Pincode 574327 Dakshina Kannada KARNATAKA 574327 India

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9448215834  
Fax    
Email  drsavithans@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Savitha N S 
Designation  Professor and Head of the department of pediatric and preventive dentistry 
Affiliation  KVG Dental College and Hospital 
Address  Room no 10 Department of Pediatric and Preventive dentistry KVG Dental College and Hospital Kurunjibhag Sullia D K Karnataka India Pincode 574327 Dakshina Kannada KARNATAKA 574327 India

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9448215834  
Fax    
Email  drsavithans@yahoo.com  
 
Source of Monetary or Material Support  
KVG Dental College and Hospital Kurunjibhag Sullia D K Karnataka India Pincode 574327 
 
Primary Sponsor  
Name  Dr P Sharvari Aithal 
Address  Room no 10 Department of Pediatric and Preventive dentistry KVG Dental College and Hospital Kurunjibhag Sullia D K Karnataka India Pincode 574327 
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 P Sharvari Aithal  Special school based  Room no 10, Department of pediatric and preventive dentistry KVG Dental college and hospital, sullia dhakshina kannada karnataka india
Dakshina Kannada
KARNATAKA 
9844916037

sharvari.aithal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KVG Dental College and Hospita  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  manual toothbrush  Children will be instructed to brush their teeth for 2 min using manual tooth brush twice daily for using soft bristle tooth brush and tooth paste and the plaque removal is assessed using plaque index . the total time duration will be 20 minutes 
Intervention  music augmented manual tooth brush   Children will be given music augmented tooth brush and the efficacy of plaque removal will be evaluated at 30 days and 60 days using plaque index and the acceptance is checked using 7-point hedonic face scale . The total duration will be 20 mintues  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  2. Permanent first molars and central incisors that have completely erupted
3. Having a fair- to –poor oral hygiene regimen
4. Children who can tightly grasp a tooth with one palm
5. Others those are able to obey straightforward commands and fine motor gestures
6. Children who do not brush their teeth with operated tooth brush
7. Consent from the parent or guardian
 
 
ExclusionCriteria 
Details  1. Consent not given from the parent or gaurdian

2. Children that are uncooperative or unwilling to participate in the study will be excluded.

3. Those suffering from cerebral palsy or other psychiatric illnesses

4. Children who are under antiepileptic medications such as phenytoin sodium valproate, phenobarbitone, ethosuximide, methosuximide, or steroids
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of plaque removal of musical tooth brush with manual tooth brush

 
baseline-30days, 60dyas 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the acceptance of musical tooth brush
To evaluate the efficacy of musical toothbrush in oral hygiene status in children with ASD-1
• To evaluate the efficacy of manual toothbrush in oral hygiene status in children with ASD-1
 
baseline-30days, 60dyas 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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 3 
Date of First Enrollment (India)   10/02/2026 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Autism Spectrum Disorder (ASD) is a genetically diverse condition that significantly hampers mental and emotional development, leading to challenges in learning, communication, and social interaction.  It is characterized by  male-to-female ratio of 4 :1. The disorder involves a complex interaction between genetic inheritance and environmental factors, influenced by epigenetic mechanisms  .Children with autism also tend to prefer repetition and sameness. Whether it’s for their preferred activities, hobbies, mealtimes, or bedtime, routines come naturally to them.1

    Oral problems in individuals with autism may arise from behaviours associated factors such as personal neglect, self-injurious behaviours, dietary habits, the impact of medication, resistance to dental care, inability to cooperate in dental settings, hyposensitivity to pain, and possible avoidance of social contact . They exhibit a preference for sweets and soft foods, coupled with a tendency to retain food within their mouths, particularly in areas such as the vestibule, interdental, and occlusal regions. Given these considerations, a proactive dental prevention approach is required more effective than treatment for children with autism.2

A study  by Sikarwar et al. showed that children with autism had poor oral hygiene and gingival health with a higher incidence of periodontal disease than normal children. People with ASD tend to have higher plaque and gingival index scores ,often requiring more periodontal treatments like scaling and root planning .Frequent gingivitis in people with autism is linked to a number of factors, including inconsistent brushing practices, a lack of manual skills, inadequate hand-eye coordination, poor oral health awareness, ignorance of teeth, and adverse drug reactions from several drugs used to treat various autistic symptoms4.  Dental caries is  a common oral manifestation among children with Autism Spectrum Disorder (ASD), representing a chronic condition that typically occurs over a lifetime. If left untreated, dental caries can lead to more severe clinical results such as pulp involvement and abscess formation, significantly affecting the quality of life for affected children5. The prevalence of dental caries in individuals with ASD is  high, reaching up to 77%, compared to 46% in non-ASD children. Additionally, gingivitis affects 97% of ASD children, while only 41% of their non-ASD counterparts experience this condition. Due to their specific dental needs, children with ASD necessitate preventive

    Tooth brushing plays a crucial role in maintaining oral health and is considered a fundamental self-care skill. Nevertheless, there is evidence suggesting that children with Autism Spectrum Disorder (ASD) encounter challenges in their daily tooth brushing practices, as found by the study conducted by Du, Yiu, King, and colleagues (2019). Preventive educational interventions, focusing on imparting a simple, correct, and effective tooth brushing technique, may be beneficial in enhancing oral health, especially for young individuals with Autism Spectrum Disorder (ASD), as highlighted in the study by Piraneh and colleagues (2022).3

                  The majority of children with autism spectrum disorder (ASD) tend to resist brushing and may attempt to avoid this daily task due to perceiving it as a tedious and disliked procedure. Parents often employ various strategies such as contingency management, offering gifts, and even using bribes to motivate their children for regular brushing. However, despite these efforts, many parents struggle to instill a genuine interest in brushing for their children.6

 Literature states that calming, non-lyrical, low tone, wind, and string instruments produce a soothing effect during dental treatment for patients. Recognizing the importance of cultivating the child’s interest in brushing, new devices have been introduced to make the experience enjoyable. One such innovation is the musical tooth brush. This toothbrush plays music when the child starts brushing making it cheerful process .7

So, this study will be aimed to evaluate the efficacy and acceptance of musical toothbrush with manual toothbrush in children with Autism spectrum disorder in Dakshina Kannada district, Karnataka.

 
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