Oral HygieneNCT05697432
Orodental Hygiene in Children With Special Needs
A study testing Oral Examination, PUFA index and Plaque index in people with Oral Hygiene, run by Altinbas University at 3 sites in Turkey (Türkiye).
Trial summary
This clinical trial aims to learn about the general oral hygiene status of children with special needs and test the effect of hygiene education on their oral and dental hygiene. The main questions it aims to answer are: What is the general oral hygiene status of children with special needs? Does brushing education and… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Oral Hygiene
- What is being tested?
- Oral Examination, PUFA index and Plaque index
- 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
- 150 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Nov 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with special needs
- Aged between 6-12 years
Who cannot join
- Refusal
- Being unable to complete oral examination due to lack of cooperation
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Maviel Rehabilitation Center
Kilis
Mine Tirnaksiz, +905069528420, dtminetirnaksiz@gmail.com
- Recruiting
Sirinler Rehabilitation Center
Kilis
Mine Tirnaksiz, +905069528420, dtminetirnaksiz@gmail.com
- Recruiting
Ugurlu Kalpler Rehabilitation Center
Kilis
Mine Tirnaksiz, +905069528420, dtminetirnaksiz@gmail.com
About this study
Official title: Evaluation of Oral and Dental Hygiene in Individuals With Special Needs Between 6 to 12 Years of Age
This clinical trial aims to learn about the general oral hygiene status of children with special needs and test the effect of hygiene education on their oral and dental hygiene. The main questions it aims to answer are:
- What is the general oral hygiene status of children with special needs?
- Does brushing education and dietary guidance to parents improve oral and dental hygiene in children with special needs? Participants will receive a complete oral and dental examination. Following this examination parents/legal guardians will be educated about the maintenance of oral and dental hygiene and dietary guidance will be provided. Patients will be evaluated one year after the education
Read the detailed description
One hundred and thirty children with special needs who are being rehabilitated at three rehabilitation centers (Maviel, Sirinler and Ugurlu Kalpler Rehabilitation Centers) in Kilis will undergo a complete oral and dental examination at which their oral bacteria (str. mutans) levels, PUFA and plaque indexes (indices that measure oral health) will be recorded. The parents/legal guardians of the children will be educated about dental hygiene toothbrushing and dietary habits leading to caries. After a year, the examination and assessments will be repeated. The change in oral hygiene indices will be evaluated.
- Conditions
- Oral Hygiene
- Being tested
- Oral Examination, PUFA index, Plaque index, Streptococcus mutans screening, Education
- Keywords
- Disabled Children, Oral Hygiene, Streptococcus mutans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ExaminationDiagnostic test
A complete examination of oral and dental hygiene any health problems will be registered
PUFA indexDiagnostic test
Also called Pulpal involvement, ulceration, fistula, abscess index
An assessment of the presence of oral conditions resulting from untreated caries. P=Pulpal involvement, U=ulceration, F=fistula, A=abscess index
Plaque indexDiagnostic test
Also called Sillness Löe PI
An assessment of the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth. The index varies between 0-4.
Streptococcus mutans screeningDiagnostic test
Also called Saliva-check mutans
A strip test for specific bacteria named streptococcus mutans, which plays an important role in caries formation, from patients' collected saliva
EducationBehavioural
Education on correct toothbrushing technique, oral hygiene, dietary education on foods detrimental for dental hygiene.
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | The children with special needs will receive a complete oral examination and then their parent/guardian will be subjected to education about oral hygiene, brushing and dietary guidance. Receives: Diagnostic Test: Oral Examination; Diagnostic Test: PUFA index; Diagnostic Test: Plaque index; Diagnostic Test: Streptococcus mutans screening; Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Saliva Check mutans test at 52 weeks
A speed test of specific bacteria named streptococcus mutans, which plays a leading role in caries formation, from patients' collected saliva. Interpreted from the strips as high, low levels of bacteria or no bacteria in saliva.
Measured: Baseline and 1 year after the education
Change from baseline in the number of teeth with each element of PUFA index at 52 weeks
An assessment of the presence of oral conditions resulting from untreated caries. P=Pulpal involvement, U=ulceration, F=fistula, A=abscess index.
Measured: Baseline and 1 year after the education
Change from baseline on the 5 point plaque index at 52 weeks
An assessment of the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth. Possible scores range from 0 (no plaque) to 4 (considerable plaque film formation)
Measured: Baseline and 1 year after the education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Nov 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HygieneStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altinbas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mine Tirnaksiz, Altinbas University
- Investigators
- Mine Tirnaksiz, Principal investigator, Altinbas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697432
- Sponsor's protocol ID
- 81
- Status last verified
- Jan 2023
- First submitted
- 14 Jan 2023
- Last updated
- 25 Jan 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 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral and Dental Hygiene in Individuals With Special Needs Between 6 to 12 Years of Age
- ClinicalTrials.gov ID
- NCT05697432
- Acronym / sponsor ID
- 81
- Conditions
- Oral Hygiene
- Keywords
- Disabled Children, Oral Hygiene, Streptococcus mutans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Altinbas UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 25 Jan 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.
This clinical trial aims to learn about the general oral hygiene status of children with special needs and test the effect of hygiene education on their oral and dental hygiene. The main questions it aims to answer are:
- What is the general oral hygiene status of children with special needs?
- Does brushing education and dietary guidance to parents improve oral and dental hygiene in children with special needs? Participants will receive a complete oral and dental examination. Following this examination parents/legal guardians will be educated about the maintenance of oral and dental hygiene and dietary guidance will be provided. Patients will be evaluated one year after the education
Detailed description
One hundred and thirty children with special needs who are being rehabilitated at three rehabilitation centers (Maviel, Sirinler and Ugurlu Kalpler Rehabilitation Centers) in Kilis will undergo a complete oral and dental examination at which their oral bacteria (str. mutans) levels, PUFA and plaque indexes (indices that measure oral health) will be recorded. The parents/legal guardians of the children will be educated about dental hygiene toothbrushing and dietary habits leading to caries. After a year, the examination and assessments will be repeated. The change in oral hygiene indices will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Diagnostic Test: Oral Examination, Diagnostic Test: PUFA index, Diagnostic Test: Plaque index, Diagnostic Test: Streptococcus mutans screening, Behavioral: EducationThe children with special needs will receive a complete oral examination and then their parent/guardian will be subjected to education about oral hygiene, brushing and dietary guidance. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with special needs
- Aged between 6-12 years
Key exclusion criteria (2 listed)
- Refusal
- Being unable to complete oral examination due to lack of cooperation
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 |
|---|---|---|
| Oral ExaminationA complete examination of oral and dental hygiene any health problems will be registered | Diagnostic test | Education |
| PUFA indexAlso: Pulpal involvement, ulceration, fistula, abscess indexAn assessment of the presence of oral conditions resulting from untreated caries. P=Pulpal involvement, U=ulceration, F=fistula, A=abscess index | Diagnostic test | Education |
| Plaque indexAlso: Sillness Löe PIAn assessment of the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth. The index varies between 0-4. | Diagnostic test | Education |
| Streptococcus mutans screeningAlso: Saliva-check mutansA strip test for specific bacteria named streptococcus mutans, which plays an important role in caries formation, from patients' collected saliva | Diagnostic test | Education |
| EducationEducation on correct toothbrushing technique, oral hygiene, dietary education on foods detrimental for dental hygiene. | Behavioural | Education |
Primary outcome
Change from baseline in Saliva Check mutans test at 52 weeks
Time frame: Baseline and 1 year after the education
A speed test of specific bacteria named streptococcus mutans, which plays a leading role in caries formation, from patients' collected saliva. Interpreted from the strips as high, low levels of bacteria or no bacteria in saliva.
Change from baseline in the number of teeth with each element of PUFA index at 52 weeks
Time frame: Baseline and 1 year after the education
An assessment of the presence of oral conditions resulting from untreated caries. P=Pulpal involvement, U=ulceration, F=fistula, A=abscess index.
Change from baseline on the 5 point plaque index at 52 weeks
Time frame: Baseline and 1 year after the education
An assessment of the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth. Possible scores range from 0 (no plaque) to 4 (considerable plaque film formation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- 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.
Mine Tirnaksiz principal investigator
Altinbas University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Examination, PUFA index and Plaque index in people with Oral Hygiene, run by Altinbas University at 3 sites in Turkey (Türkiye).
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 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: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mine Tirnaksiz (+905069528420, dtminetirnaksiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Saliva Check mutans test at 52 weeks (time frame: Baseline and 1 year after the education). The study lists 3 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 25 Jan 2023.