Hearing Impaired ChildrenNCT06089564
Effectiveness of Skit Video to Improve Oral Hygiene Status of Children With Hearing Impairment
A study testing Skit video, Pictorial, Sign language in people with Hearing Impaired Children, run by Dow University of Health Sciences at 2 sites in Pakistan.
Trial summary
Introduction: Oral health is considered as a vital component of overall health and its importance in children may not be disregarded. In children with hearing impairment, communication barriers may hamper their understanding of oral hygiene practices, making them particularly vulnerable to dental problems. Read more about this study
- Who is it for?
- Ages 7 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Impaired Children
- What is being tested?
- Skit video, Pictorial, Sign language
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPakistan
- Study dates
- 11 Apr 2023to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children with hearing impairment and total hearing loss at birth
- Aged 7 to 20 years for both genders,
- Minimum of 20 teeth in the oral cavity
- Children with mild, moderate, and severe gingivitis
Who cannot join
- Children with dental plaque covered more than two-thirds of their tooth surface, had a plaque score of >1.0
- Children with fair to poor oral hygiene
- Children who had previously participated in any activity or programme promoting oral health within the previous six months
- Children with mild to moderate hearing loss
- Children taking long-term antibiotics
- Children who had used mouthwash within the previous three months
Show all 9Show fewer
- Children with any known systemic diseases
- Presence of extensive dental calculus
- Uncooperative children
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
ABSA School and college for deaf
Karachi, Sindh, 22770
Ida Rieu College For Blind And Deaf
Karachi, Sindh, 77440
About this study
Official title: Enhancing Oral Hygiene in Children With Hearing Impairment: The Impact of Skit Video Interventions - A Randomized Controlled Trial
Introduction: Oral health is considered as a vital component of overall health and its importance in children may not be disregarded. In children with hearing impairment, communication barriers may hamper their understanding of oral hygiene practices, making them particularly vulnerable to dental problems. Objective: The objective of this study was to compare effectiveness of skit video, pictorial and sign language interventions to improve oral hygiene status of children with hearing impairment. Methods: Sixty children were completed the study and allocated randomly into each group with twenty children as follows: group A: Skit video, group B: Pictorial, and group C: Sign language. Mean gingival and OHI scores were recorded before and after implementation of interventions. Oral hygiene habits, oral hygiene and gingival index scores were recorded by structured questionnaire.
- Conditions
- Hearing Impaired Children
- Being tested
- Skit video, Pictorial, Sign language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skit video, Pictorial, Sign languageBehavioural
Three oral health educational intervention groups, group A (skit video), group B (pictorial) and group C (sign language) by using Sequentially Numbered Sealed Opaque Envelopes (SNOSE). Children picked a sealed envelope randomly and assigned to oral health education intervention group A, B and C. Participants in group A were assigned a skit video method of oral hygiene intervention and shown 5 minute video on what to eat and how to brush their teeth. The video included that what is good and bad for teeth, and how to brush which includes method, time and duration of tooth brushing. Participants assigned to group B and C was provided same instructions for tooth brushing and eating habits in the form of pictures and sign language respectively. The children of Group A received instructions in the form of laminated cards and asked to take with them at home. Participants in group C were received instructions in sign language in the presence of teacher.
| Study group | Role | What they receive |
|---|---|---|
| Skit video | Active comparator | The video was shown to children lasting for 5 minutes. It was about oral habits, good and bad food. Video was also showed brushing technique. Receives: Behavioral: Skit video, Pictorial, Sign language |
| Pictorial | Active comparator | The pictures related to brushing technique and oral health advices such as good and bad habits was provided in the form of laminated cards. The children has taken those cards along with them. Receives: Behavioral: Skit video, Pictorial, Sign language |
| Signed Language | No intervention | The oral health education related to oral habits, good and bad food was delivered via sign language with the help of children sign language teacher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index
Decrease in mean dental plaque scores from baseline to after intervention
Measured: one month
Gingival Index
Decrease in mean gingival scores from baseline to after intervention
Measured: one month
Secondary outcomes (1)
Oral Hygiene Index
Decrease in mean OHI scores from baseline to after intervention
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start11 Apr 2023
- Primary completion23 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Impaired ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Moin, Dow University of Health Sciences
- Investigators
- Maria Moin, MDS, Principal investigator, Bahria University Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089564
- Sponsor's protocol ID
- DowUHS 1
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Oral Hygiene in Children With Hearing Impairment: The Impact of Skit Video Interventions - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06089564
- Acronym / sponsor ID
- DowUHS 1
- Conditions
- Hearing Impaired Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 23 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Oral health is considered as a vital component of overall health and its importance in children may not be disregarded. In children with hearing impairment, communication barriers may hamper their understanding of oral hygiene practices, making them particularly vulnerable to dental problems. Objective: The objective of this study was to compare effectiveness of skit video, pictorial and sign language interventions to improve oral hygiene status of children with hearing impairment. Methods: Sixty children were completed the study and allocated randomly into each group with twenty children as follows: group A: Skit video, group B: Pictorial, and group C: Sign language. Mean gingival and OHI scores were recorded before and after implementation of interventions. Oral hygiene habits, oral hygiene and gingival index scores were recorded by structured questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Skit video | Active comparator | Behavioral: Skit video, Pictorial, Sign languageThe video was shown to children lasting for 5 minutes. It was about oral habits, good and bad food. Video was also showed brushing technique. |
| Pictorial | Active comparator | Behavioral: Skit video, Pictorial, Sign languageThe pictures related to brushing technique and oral health advices such as good and bad habits was provided in the form of laminated cards. The children has taken those cards along with them. |
| Signed Language | No intervention | –The oral health education related to oral habits, good and bad food was delivered via sign language with the help of children sign language teacher. |
Who may qualify
- Ages
- 7 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children with hearing impairment and total hearing loss at birth
- Aged 7 to 20 years for both genders,
- Minimum of 20 teeth in the oral cavity
- Children with mild, moderate, and severe gingivitis
Key exclusion criteria (9 listed)
- Children with dental plaque covered more than two-thirds of their tooth surface, had a plaque score of >1.0
- Children with fair to poor oral hygiene
- Children who had previously participated in any activity or programme promoting oral health within the previous six months
- Children with mild to moderate hearing loss
- Children taking long-term antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skit video, Pictorial, Sign languageThree oral health educational intervention groups, group A (skit video), group B (pictorial) and group C (sign language) by using Sequentially Numbered Sealed Opaque Envelopes (SNOSE). Children picked a sealed envelope randomly and assigned to oral health education intervention group A, B and C. Participants in group A were assigned a skit video method of oral hygiene intervention and shown 5 minute video on what to eat and how to brush their teeth. The video included that what is good and bad for teeth, and how to brush which includes method, time and duration of tooth brushing. Participants assigned to group B and C was provided same instructions for tooth brushing and eating habits in the form of pictures and sign language respectively. The children of Group A received instructions in the form of laminated cards and asked to take with them at home. Participants in group C were received instructions in sign language in the presence of teacher. | Behavioural | Pictorial, Skit video |
Primary outcome
Plaque Index
Time frame: one month
Decrease in mean dental plaque scores from baseline to after intervention
Gingival Index
Time frame: one month
Decrease in mean gingival scores from baseline to after intervention
1 secondary outcome
Oral Hygiene Index
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Hearing Impaired Children
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Artificial Grammar Learning in Children Who Are Deaf or Hard-of-Hearing: Stimulus Length Effect
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Moin, MDS principal investigator
Bahria University Dental College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skit video, Pictorial, Sign language in people with Hearing Impaired Children, run by Dow University of Health Sciences at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.