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Oral Health Education for Caregivers of Children With Disabilities

Effectiveness of an Oral Health Education Program for Caregivers of Children With Developmental Disabilities: A Cluster Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03157596
Enrollment
61
Registered
2017-05-17
Start date
2016-07-01
Completion date
2017-01-17
Last updated
2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental Disability

Keywords

disability, developmental disability, special healthcare needs

Brief summary

Considering the impact of caregivers' oral health knowledge, attitudes and practices on the oral health of their children; we introduced an educational program to the parents and caregivers of children with developmental disabilities about the oral healthcare of their developmentally disabled children to rise up with the oral health status of those children.

Detailed description

* Target Population; Parents of Children with DD enrolled in selected special education centers in Khartoum state, Khartoum, Sudan, and their developmentally disabled children. * A convenient sample of two special education centers were selected randomly from a list of all the 105 special education centers registered at the State Ministry of Education, and allocated into intervention and control groups. * One center was used as case who received the educational program and the other center was used as a control group. * Eligibility Criteria: child aged 3-18, with a developmental disability, caregivers approval to participate (signed the informed consent). * All the Children who met the eligibility criteria in both centers were examined and all their parents were interviewed, before and after the intervention. * An interview questionnaire for the parents of Children with DD in both centers was used to evaluate their knowledge and attitude toward the oral health care of their children before and 3 months after the intervention. * Oral examination was carried out to determine the baseline oral hygiene level and treatment needs of the Children with DD, before the educational session. * A second examination was carried out after a period of 3 months after the educational session, to determine any change in oral hygiene and treatment needs of the children after their parents and or caregivers' attendance to the educational session. * The baseline and follow up examination were carried out blindly by a calibrated dentist. * The same examiner carried out the baseline and follow up examinations to avoid any inter-examiner variations. * Oral examination was arranged according to oral health surveys basic methods recommended by WHO in 2013. * The Simplified Oral Hygiene Index (measuring debris index and calculus index). * Dentition Status and Treatment Needs chart provided in oral health assessment forms for children by the WHO 2013 was used to determine the amount of unmet dental needs and help in evaluating the caregivers' oral healthcare behaviours and the frequency of dental visits.

Interventions

OTHEROral Health Educational Program for Caregivers of Children with developmental disabilities

Oral Health Education Program for Caregivers of Children with developmental disabilities included information about health issues and obstacles encountered in children with DD & methods of prevention and management. It also emphasized on proper oral hygiene measures for this group. (University of Washington 2010)

Sponsors

Sudan Medical Specialization Board (SMSB)
CollaboratorOTHER_GOV
Elfatih Malik, MD
CollaboratorUNKNOWN
ElTyeb, Sara Amir Hassan, M.D.
Lead SponsorINDIV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* has a developmental disability. * enrolled in any of the randomly selected special education schools. * caregivers signed the informed consent.

Exclusion criteria

* not a student in any of the randomly selected special education schools. * caregivers refused to participate and sign the informed consent. * age not in the range of 3 - 18 years old.

Design outcomes

Primary

MeasureTime frameDescription
improvement in oral hygiene status of children with developmental disabilities3 monthssimplified oral hygiene index recorded from the oral examination of children with disabilities are analyzed in cluster level for both intervention and control groups, and compared before and 3 months after the educational intervention.

Secondary

MeasureTime frameDescription
improvement in caregivers' knowledge about oral healthcare of their developmentally disabled children3 monthsscore of knowledge recorded in the interview questionnaire to the caregivers of children with disabilities are analyzed in cluster level for both intervention and control groups, and compared before and 3 months after the educational intervention.
improvement in caregivers' attitude towards the oral healthcare of their developmentally disabled children3 monthsscore of attitude recorded in the interview questionnaire to the caregivers of children with disabilities are analyzed in cluster level for both intervention and control groups, and compared before and 3 months after the educational intervention.
decrease in the unmet treatment needs of children with developmental disabilities3 monthsscore of unmet treatment needs recorded from the oral examination of children with disabilities are analyzed in cluster level for both intervention and control groups, and compared before and 3 months after the educational intervention.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026