Hearing LossNCT03030014
Effect of Dental Educational Program on Oral Hygiene Status Among Institutionalized Deaf Children
A study testing educational programm and no educational program in people with Hearing Loss, run by Cairo University.
Trial summary
assess the effect of dental educational program on oral hygiene among institutionalized hearing impaired and mute children in Cairo, Egypt. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- educational programm and no educational program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Jun 2017
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged from 6-12 years with mixed dentition.
- Institutionalized Deaf children in Cairo, Egypt.
Who cannot join
- Children above the age of 12 years and below the age of 6 years
- Patient un able to give informed consent
- Patient suffering from any other type of disability such as (mental retardation, physically and mentally handicapped, .etc.)
- Medically compromised patient
- Patient who were absent in the day of examination
About this study
Official title: Effect of Dental Educational Program on Oral Hygiene Status Among Institutionalized Deaf Children. A Randomized Controlled Trial.
assess the effect of dental educational program on oral hygiene among institutionalized hearing impaired and mute children in Cairo, Egypt.
Read the detailed description
- Evaluate participants satisfaction regarding the dental educational program(learning teeth brushing technique)
- Measure the oral hygiene index simplified to the participants at a different follow up periods for assessing the effect of the dental educational program on oral hygiene.
- Conditions
- Hearing Loss
- Being tested
- educational programm, no educational program
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational programmBehavioural
Oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.
no educational programOther
without oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.
| Study group | Role | What they receive |
|---|---|---|
| educational programm | Experimental | Oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.
Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children. Receives: Behavioral: educational programm |
| no educational programm | Placebo comparator | without educational program Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children. Receives: Other: no educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
this outcome will be assessed via questionnaire
Measured: 6 weeks
Secondary outcomes (1)
oral hygiene index simplified
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startFeb 2017 (estimated)
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sohil Souod Ali Shaalan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030014
- Sponsor's protocol ID
- SShaalan
- Status last verified
- Feb 2017
- First submitted
- 20 Jan 2017
- Last updated
- 8 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dental Educational Program on Oral Hygiene Status Among Institutionalized Deaf Children. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03030014
- Acronym / sponsor ID
- SShaalan
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2017 (estimated)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 24 Jan 2017 (estimated)
- 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.
assess the effect of dental educational program on oral hygiene among institutionalized hearing impaired and mute children in Cairo, Egypt.
Detailed description
- Evaluate participants satisfaction regarding the dental educational program(learning teeth brushing technique)
- Measure the oral hygiene index simplified to the participants at a different follow up periods for assessing the effect of the dental educational program on oral hygiene.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| educational programm | Experimental | Behavioral: educational programmOral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing. Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children. |
| no educational programm | Placebo comparator | Other: no educational programwithout educational program Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged from 6-12 years with mixed dentition.
- Institutionalized Deaf children in Cairo, Egypt.
Key exclusion criteria (5 listed)
- Children above the age of 12 years and below the age of 6 years
- Patient un able to give informed consent
- Patient suffering from any other type of disability such as (mental retardation, physically and mentally handicapped, .etc.)
- Medically compromised patient
- Patient who were absent in the day of examination
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 |
|---|---|---|
| educational programmOral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children. | Behavioural | educational programm |
| no educational programwithout oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children. | Other | no educational programm |
Primary outcome
patient satisfaction
Time frame: 6 weeks
this outcome will be assessed via questionnaire
1 secondary outcome
oral hygiene index simplified
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing educational programm and no educational program in people with Hearing Loss, run by Cairo University.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
patient satisfaction (time frame: 6 weeks). 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 8 Feb 2017.