Effectiveness of sign language-based cartoon oral health education for hearing-impaired children
| ISRCTN | ISRCTN17097981 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17097981 |
| Secondary identifying numbers | UDDS-2370-18042022/SRC-353 |
- Submission date
- 14/08/2025
- Registration date
- 18/08/2025
- Last edited
- 18/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study aimed to improve oral health awareness among hearing-impaired children. Many children with hearing impairments face challenges in understanding traditional health education. To address this, a 10-minute cartoon film was developed in Unified Arabic Sign Language that teaches children about teeth, common oral health problems, and good oral hygiene practices such as brushing, flossing, rinsing, and healthy diet habits. The film included animations, subtitles, sound effects, and clear sign language interpretation to make learning easier and more engaging.
Who can participate?
Children aged 6–12 years
What does the study involve?
Children in the study were randomly assigned to either the intervention group, who watched the educational film, or the control group, who received no film during the study period but were offered it afterwards. Oral health was measured using standard dental exams to check plaque and gingival health, and children also completed a questionnaire to assess their knowledge. Toothbrushes were given to all participants at the start. Assessments were conducted at the beginning, at six weeks, and at twelve weeks after the start.
What are the possible benefits and risks of participating?
Possible benefits: Children may benefit from improved knowledge of oral health and better oral hygiene practices. The educational film, adapted to their communication needs, provides accessible information that can help prevent oral diseases such as dental caries and gum disease.
Possible risks: The study involved minimal risk. Risks were limited to routine oral examinations (mild discomfort during plaque and gingival assessments). No invasive procedures were performed, and toothbrushes were provided to promote safe hygiene practices.
Where is the study run from?
Damascus University, Syria
When is the study starting and how long is it expected to run for?
January 2021 to April 2022
Who is funding the study?
Damascus University, Syria
Who is the main contact?
Dr Hasan Alzoubi, dr.hasan.alzoubi.93@gmail.com
Contact information
Scientific, Principal Investigator
Damascus University
Mazzeh
Damascus
0000
Syria
| Phone | +963933173023 |
|---|---|
| Alemar.ghannam.2222@hotmail.com |
Scientific
Damascus University
Mazzeh
Damascus
0000
Syria
| Phone | +963966956753 |
|---|---|
| mdashash@yahoo.com |
Public, Scientific
Damascus University
Mazzeh
Damascus
0000
Syria
| Phone | +963943647659 |
|---|---|
| dr.hasan.alzoubi.93@gmail.com |
Study information
| Study design | Single-center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Care home |
| Study type | Prevention |
| Participant information sheet | 47839 Participant_Information_Sheet.pdf |
| Scientific title | A randomized controlled trial assessing the effectiveness of sign language-based cartoon oral health education on hearing-impaired children |
| Study acronym | SLICE |
| Study objectives | To evaluate the impact of oral health education on increasing awareness among children with hearing impairments, and to explore the potential of modern technologies—specifically sign language-based cartoon films—in enhancing educational experiences, improving oral hygiene practices, and preventing oral diseases. |
| Ethics approval(s) |
Approved 18/04/2022, Biomedical Research Ethics Committee of Damascus University (University Presidency Building, University Campus, Baramkeh 23J89, Damascus, 00000, Syria; +963 1133923012; president@damasuniv.edu.sy), ref: 2370 |
| Health condition(s) or problem(s) studied | Oral health awareness and oral hygiene practices among children with hearing impairments Prevention of dental caries and periodontal diseases |
| Intervention | Children in the intervention group received oral health education through a 10-minute sign language–based cartoon film titled "Oral Health", developed in Unified Arabic Sign Language with subtitles, animations, and sound effects. The film was designed according to Mayer’s Cognitive Theory of Multimedia Learning and covered topics such as tooth anatomy, functions, common oral diseases, and oral hygiene practices. It was shown on a laptop in short, engaging segments to minimize cognitive overload. The control group received no intervention during the study period but was offered the same educational film after completion. All participants underwent oral examinations at baseline, 6 weeks, and 12 weeks, with plaque and gingivitis assessed using the Silness–Löe indices. Toothbrushes were provided to all children at baseline. Participants were randomly allocated into intervention and control groups using a computer-generated random sequence. Allocation concealment was achieved through sequentially numbered, sealed opaque envelopes prepared by an independent researcher not involved in recruitment or assessment. |
| Intervention type | Behavioural |
| Primary outcome measure | Oral health knowledge scoring measured using a structured questionnaire designed for hearing-impaired children at baseline and 12 weeks |
| Secondary outcome measures | Secondary outcome measures were assessed at baseline, 6 and 12 weeks: 1. Plaque accumulation measured using the Silness–Löe Plaque Index (PI) 2. Gingival health measured using the Silness–Löe Gingival Index (GI) |
| Overall study start date | 15/01/2021 |
| Completion date | 30/04/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 90 |
| Total final enrolment | 90 |
| Key inclusion criteria | 1. Children diagnosed with hearing impairment 2. Proficient in sign language sufficient to understand classroom instructions |
| Key exclusion criteria | 1. Presence of systemic illnesses (neurological, cardiac, metabolic, or developmental disorders) that could interfere with communication, comprehension, or oral hygiene practices, as reported by parents and verified by medical records when available 2. Prolonged absence from school during the study period 3. Ongoing orthodontic treatment 4. Non-cooperative behavior, defined as a score of 1 (“definitely negative”) or 2 (“negative”) on the Frankl Behavior Rating Scale during the initial dental screening, based on caregiver interpretation and clinical observation |
| Date of first enrolment | 14/02/2021 |
| Date of final enrolment | 23/07/2021 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
0000
Syria
Sponsor information
University/education
Baramkeh
Damascus
0000
Syria
| Phone | +9631133923012 |
|---|---|
| president@damasuniv.edu.sy | |
| Website | https://www.damascusuniversity.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 01/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | Contact for dataset access: Dr Hasan Alzoubi, Damascus University (email: dr.hasan.alzoubi.93@gmail.com) Type of data: De-identified participant-level data, including oral health questionnaire responses and clinical indices (Plaque Index, Gingival Index). Timing of availability: Available upon request following publication of the primary study results, from 01/09/2025 onwards. Consent: Written informed consent for participation and data use was obtained from caregivers/parents of all participants. Data anonymization: All data will be de-identified and anonymized prior to sharing, in compliance with institutional and GDPR-equivalent standards. Restrictions: Data sharing will require a data-sharing agreement and may be subject to additional ethical review. Additional comments: Data will be provided in commonly used formats (Excel, CSV, SPSS) to facilitate secondary analyses. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 18/08/2025 | No | Yes |
Additional files
Editorial Notes
18/08/2025: Trial's existence confirmed by Damascus University.
