| CTRI Number |
CTRI/2022/10/046615 [Registered on: 19/10/2022] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating oral health in children with autism to improve Oral Health using music |
|
Scientific Title of Study
|
Evaluation of Music as Interventional Therapy in Promoting Oral Health
in Children with Autism Spectrum Disorder- A Randomized Controlled
Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramya Raja |
| Designation |
post graduate |
| Affiliation |
Indira Gandhi Institute of Dental Sciences,SBV,Pillaiyarkuppam,Puducherry. |
| Address |
Department of pediatric and preventive dentistry,
Indira Gandhi dental college, Pillaiyarkuppam, cuddalore main road, Puducherry.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9095086266 |
| Fax |
|
| Email |
ramya2link@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prathima G S |
| Designation |
professor and heaad |
| Affiliation |
Indira Gandhi Institute of Dental Sciences,SBV,Pillaiyarkuppam,Puducherry. |
| Address |
Department of Pediatric and Preventive dentistry, Indira Gandhi institute of dental sciences , Puducherry.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9448405074 |
| Fax |
|
| Email |
prathimag@igids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Ramya Raja |
| Designation |
post graduate |
| Affiliation |
Indira Gandhi Institute of Dental Sciences,SBV,Pillaiyarkuppam,Puducherry. |
| Address |
Department of pediatric and preventive dentistry,
Indira Gandhi dental college, Pillaiyarkuppam, cuddalore main road, Puducherry.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9095086266 |
| Fax |
|
| Email |
ramya2link@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Dental Sciences,Puducherry. |
|
|
Primary Sponsor
|
| Name |
Ramya R |
| Address |
IGIDS,puducherry. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mrs Bagyalakshmi |
Sathya special school |
Karuvadikuppam, Puducherry.
Pondicherry
PONDICHERRY |
605008
bagyalakshmi@satyaspecialschool.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC IGIDS |
Approved |
| IEC IGIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music and Movement therapy |
The training session comprises 3 parts.
Part A: Acclimatize the participants to music with a “hello†song.
Part B: The intervention in the form of lyrics in vernacular language giving instructions on proper
brushing technique (12 steps) by the principal investigator singing, doing actions, and the movements in
rhythmic sequential order.
Part C: session to conclude with a goodbye song.
Frequency:
4 sessions /week for 1 month at school.
A recorded video will be given to the parents to be played during toothbrushing at home.
Follow-up phone calls to parents will
be done, once a week to verify whether
the children are brushing regularly.
A Checklist will be given to parents to rate the performance of tooth
brushing everyday. The performance of tooth brushing will be evaluated by the examiner at subsequent follow ups and categorized
into – Good, Moderate, Poor.
At the end of 1
st month of the
musical intervention, parent will be asked to fill out a feedback form
asking if the participant got involved in performing the musical act and if
the participant brushed his or her teeth.
Duration of training: 25-30 minutes |
| Comparator Agent |
Visual pedagogy |
The training session comprises of
showing the visual pedagogy
method of toothbrushing.
ALBUM with instructions demonstrating and
summarizing the 12 steps of
tooth brushing to the audience.
Frequency:
4 sessions /week for 1 month
at school.
An album will be given to be
used at home during tooth
brushing at home.
Follow-up phone calls to parents will be done, once a week to verify whether the children are brushing
regularly.
A Checklist will be given to
parents to rate the performance of tooth brushing everyday.
The performance of tooth brushing will be evaluated by the examiner at subsequent follow-ups and categorized into – Good,
Moderate, and Poor.
At the end of the 1
st month,
the parent will be asked to fill out a feedback form asking if the participant brushed his or
her teeth using a
toothbrushing album.
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children aged - 7 to 15 years with mild to moderate ASD (ISAA scale) and can follow simple verbal instructions.
Children who are not using any other type of intervention currently for
toothbrushing. |
|
| ExclusionCriteria |
| Details |
Children who underwent oral prophylaxis in the past 3 months.
Children with ASD have other co-morbidities.
Children who have been using any intervention mode to improve their tooth
brushing habit. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
improvement in plaque and gingival index of children with
ASD.
To assess the performance of tooth brushing skills.
|
Baseline,1 month,2 month, and 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/10/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Autism spectrum disorder is a neurodevelopmental disorder characterized by impairments in social, communication, functional skills with restricted or repetitive behaviors.Individuals with ASD have complex oral health needs, which may be related to underlying congenital or developmental defects, as well as a lack of access to adequate personal and professional care to maintain oral health.Dental caries and periodontal diseases are the most common secondary conditions affecting people with ASD. The commonly used methods to help improve the oral health care for children with ASD includes the use of Behaviour guidance techniques, Visual pedagogy, Video modelling, Picture Exchange Communication System, yoga as an adjunct therapy, mobile-based applications, Teaching and Education of Autistic and Related Communication Handicapped Children (TEACCH), social stories and tooth brushing checklists to promote positive behaviours and communication. However a systematic review stated that Visual pedagogy is an effective method in improving and maintaining good oral health in patients with ASDs, as evidenced by improvements in Plaque index and Gingival index across all studies. Children with ASD find musical activities enjoyable due to their enhanced musical understanding. Therefore, clinicians and special educators often use musicbased activities in school settings to engage them. These activities can be nonintimidating experiences wherein a child with ASD spontaneously explores various musical instruments with the trainer joining in and copying the child’s actions. children with ASD have difficulties with direct social engagement hence socially embedded group musical activities provide excellent opportunities to engage in predictable and comfortable interactions with social partners. In 2020, Yenna et al in their study used music therapy as intervention in children with ASD and ID and found that the use of music therapy increased the social skills in children. Keeping in mind that music-based interventions are particularly attractive for
individuals with ASDs and there is no research using music therapy as an intervention
to improve functional skills in children with ASD. Therefore, this study is designed
to assess whether music as an interventional tool, helps teach tooth brushing skills in
children with ASD. The findings of this study may aid in improving oral hygiene in
children with ASD. |