Hearing LossNCT05099146
Impact of Oral Health Education on Oral Hygiene Status of Deaf Children
A study testing pictures and video in people with Hearing Loss, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Objective: To compare the impact of pictorial and video demonstration oral health educational interventions on oral hygiene status of children aged 12-16 years with hearing impairment. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- pictures and video
- 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
- 1 sitePakistan
- Study dates
- 5 Oct 2019to 2 Jan 2020
- 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with hearing impairment
- Children with age of 12-16 years
- Children with no systemic disease
- Children with Plaque adhering to the free gingival margin, more than one third and more than two thirds of tooth surface
- Children with mild, moderate and severe gingivitis
- Agreement on written accent
- Agreement to comply with study visits and procedure
Who cannot join
- Conditions requiring antibiotic pre-medication prior to dental examination
- Children with extensive dental calculus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Oral Health Educational Interventions on Oral Hygiene Status of Deaf Children - A Randomized Controlled Trial
Objective: To compare the impact of pictorial and video demonstration oral health educational interventions on oral hygiene status of children aged 12-16 years with hearing impairment.
Methods: This randomized controlled trial spanned over the period of three months was conducted in purposively selected three schools of deaf children of Karachi. Baseline dental examination was performed to assess the dental plaque and gingival status of study participants. Dental plaque and gingival status of the participants was assessed by employing the World Health Organization recommended Plaque Index and Gingival Index. The 60 children were than randomly allocated into three interventional groups, pictorial, video and control, 20 in each group. The children were examined again after one month of oral health education provision by single examiner. Tooth brushes were provided to students at the time of baseline examination to use for one month. Collected data was subjected to statistical analysis and described in terms of Mean and Standard Deviation, mixed model ANNOVA was applied to see the difference between the mean plaque and gingival scores of three groups after one month. The p-value of <0.05 was considered as statistically significant at the 95% confidence interval.
Read the detailed description
Background: Health education, conventionally and appropriately, one of the foundation of preventive dentistry, has over the years involved in significant investments of time, power, human resources and funds. Children with impaired hearing have difficulties in speaking and communication and so learning process would be longer and even more challenging than the other children without such disabilities.
Objective: To compare the impact of pictorial and video demonstration oral health educational interventions on oral hygiene status of children aged 12-16 years with hearing impairment.
Methods: This randomized controlled trial spanned over the period of three months was conducted in purposively selected three schools of deaf children of Karachi. Baseline dental examination was performed to assess the dental plaque and gingival status of study participants. Dental plaque and gingival status of the participants was assessed by employing the World Health Organization recommended Plaque Index and Gingival Index. The 60 children were than randomly allocated into three interventional groups, pictorial, video and control, 20 in each group. The children were examined again after one month of oral health education provision by single examiner. Tooth brushes were provided to students at the time of baseline examination to use for one month. Collected data was subjected to statistical analysis and described in terms of Mean and Standard Deviation, mixed model ANNOVA was applied to see the difference between the mean plaque and gingival scores of three groups after one month. The p-value of <0.05 was considered as statistically significant at the 95% confidence interval.
- Conditions
- Hearing Loss
- Being tested
- pictures, video, control
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
picturesBehavioural
pictures with brushing technique demonstrated technique for proper brushing
videoBehavioural
video of brushing technique demonstrated technique for proper brushing
controlBehavioural
oral hygiene instructions provided
| Study group | Role | What they receive |
|---|---|---|
| pictorial | Experimental | brushing technique taught by using pictures Receives: Behavioral: pictures |
| video | Experimental | brushing technique taught by showing video Receives: Behavioral: video |
| control | Experimental | only oral hygiene instructions provided Receives: Behavioral: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of dental plaque status
Assessed by plaque index, Change of plaque score From high to low levels after1 month
Measured: one month
Secondary outcomes (1)
Change in oral hygiene status
Assessed by oral hygiene index, Change of Oral hygiene scores From high to low levels after 1 month
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 posted29 Oct 2021
- Study start5 Oct 2019
- Primary completion5 Dec 2019
- Study completion2 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies 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
- None (open label)
- 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, DOW UNIVERSITY OF HEALTH SCINCES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099146
- Sponsor's protocol ID
- DowMDS
- Status last verified
- Nov 2021
- First submitted
- 13 Sep 2021
- Last updated
- 10 Nov 2021
- 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 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oral Health Educational Interventions on Oral Hygiene Status of Deaf Children - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05099146
- Acronym / sponsor ID
- DowMDS
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 5 Oct 2019 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 2 Jan 2020 (actual)
- First posted
- 29 Oct 2021 (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.
Objective: To compare the impact of pictorial and video demonstration oral health educational interventions on oral hygiene status of children aged 12-16 years with hearing impairment.
Methods: This randomized controlled trial spanned over the period of three months was conducted in purposively selected three schools of deaf children of Karachi. Baseline dental examination was performed to assess the dental plaque and gingival status of study participants. Dental plaque and gingival status of the participants was assessed by employing the World Health Organization recommended Plaque Index and Gingival Index. The 60 children were than randomly allocated into three interventional groups, pictorial, video and control, 20 in each group. The children were examined again after one month of oral health education provision by single examiner. Tooth brushes were provided to students at the time of baseline examination to use for one month. Collected data was subjected to statistical analysis and described in terms of Mean and Standard Deviation, mixed model ANNOVA was applied to see the difference between the mean plaque and gingival scores of three groups after one month. The p-value of <0.05 was considered as statistically significant at the 95% confidence interval.
Detailed description
Background: Health education, conventionally and appropriately, one of the foundation of preventive dentistry, has over the years involved in significant investments of time, power, human resources and funds. Children with impaired hearing have difficulties in speaking and communication and so learning process would be longer and even more challenging than the other children without such disabilities.
Objective: To compare the impact of pictorial and video demonstration oral health educational interventions on oral hygiene status of children aged 12-16 years with hearing impairment.
Methods: This randomized controlled trial spanned over the period of three months was conducted in purposively selected three schools of deaf children of Karachi. Baseline dental examination was performed to assess the dental plaque and gingival status of study participants. Dental plaque and gingival status of the participants was assessed by employing the World Health Organization recommended Plaque Index and Gingival Index. The 60 children were than randomly allocated into three interventional groups, pictorial, video and control, 20 in each group. The children were examined again after one month of oral health education provision by single examiner. Tooth brushes were provided to students at the time of baseline examination to use for one month. Collected data was subjected to statistical analysis and described in terms of Mean and Standard Deviation, mixed model ANNOVA was applied to see the difference between the mean plaque and gingival scores of three groups after one month. The p-value of <0.05 was considered as statistically significant at the 95% confidence interval.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pictorial | Experimental | Behavioral: picturesbrushing technique taught by using pictures |
| video | Experimental | Behavioral: videobrushing technique taught by showing video |
| control | Experimental | Behavioral: controlonly oral hygiene instructions provided |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children with hearing impairment
- Children with age of 12-16 years
- Children with no systemic disease
- Children with Plaque adhering to the free gingival margin, more than one third and more than two thirds of tooth surface
- Children with mild, moderate and severe gingivitis
Key exclusion criteria (2 listed)
- Conditions requiring antibiotic pre-medication prior to dental examination
- Children with extensive dental calculus
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 |
|---|---|---|
| picturespictures with brushing technique demonstrated technique for proper brushing | Behavioural | pictorial |
| videovideo of brushing technique demonstrated technique for proper brushing | Behavioural | video |
| controloral hygiene instructions provided | Behavioural | control |
Primary outcome
change of dental plaque status
Time frame: one month
Assessed by plaque index, Change of plaque score From high to low levels after1 month
1 secondary outcome
Change in oral hygiene status
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 10 Nov 2021.
- Individual participant dataSharing planned: No
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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
DOW UNIVERSITY OF HEALTH SCINCES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pictures and video in people with Hearing Loss, run by Dow University of Health Sciences at 1 site 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 7 inclusion and 2 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 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
change of dental plaque status (time frame: one month). 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 10 Nov 2021.