Oral HygieneEarly Phase 1NCT02989233
Impact of Three Different Education Methods on Oral Hygiene
A Early Phase 1 study testing Non-surgical periodontal treatment in people with Oral Hygiene, run by Umut BALLI.
Trial summary
In the present study, 144 children (72 males and 72 females), whose ages ranged between 8-13, were divided into 12 equal experimental groups according to their ages and gender. They were all considered to have poor hygiene. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene
- What is being tested?
- Non-surgical periodontal treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2014
- Phase
- Early Phase 1
- 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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- According to the Simplified Oral Hygiene Index, the patients having the score of 2 and over were accepted.
Who cannot join
- According to the Simplified Oral Hygiene Index, the patients having the score under 2 were not included in the study
About this study
Official title: Impact of Three Different Education Methods on Oral Hygiene and Theoretical Knowledge of Schoolchildren
In the present study, 144 children (72 males and 72 females), whose ages ranged between 8-13, were divided into 12 equal experimental groups according to their ages and gender. They were all considered to have poor hygiene. Only one out of the three different education methods (brochure, model or video) was applied to each group. The percentage change in PI, GI, BOP and theoretical test points from the baseline to the 6th months were evaluated.
Read the detailed description
Aim: The aim the present study was to evaluate the impact of three different education methods on the oral hygiene levels of school children using clinical and theoretical findings.
Methods: In the present study, 144 children (72 males and 72 females), whose ages ranged between 8-13, were divided into 12 equal experimental groups according to their ages and gender. They were all considered to have poor hygiene. Only one out of the three different education methods (brochure, model or video) was applied to each group. The percentage change in PI, GI, BOP and theoretical test points from the baseline to the 6th months were evaluated. The data was statistically analysed by using Kolmogorov-Smirnov and One-way ANOVA tests.
- Conditions
- Oral Hygiene
- Being tested
- Non-surgical periodontal treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentOther
Scaling and oral hygiene instructions with brochure, model or video
| Study group | Role | What they receive |
|---|---|---|
| Brochure-Female-8/10 | Active comparator | Female 8-10 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment Receives: Other: Non-surgical periodontal treatment |
| Brochure-Male-8/10 | Active comparator | Male 8-10 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment Receives: Other: Non-surgical periodontal treatment |
| Model-Female-8/10 | Active comparator | Female 8-10 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment Receives: Other: Non-surgical periodontal treatment |
| Model-Male-8/10 | Active comparator | Male 8-10 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment Receives: Other: Non-surgical periodontal treatment |
| Video-Female-8/10 | Active comparator | Female 8-10 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment Receives: Other: Non-surgical periodontal treatment |
| Video-Male-8/10 | Active comparator | Male 8-10 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment Receives: Other: Non-surgical periodontal treatment |
| Brochure-Female-11/13 | Active comparator | Female 11-13 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment Receives: Other: Non-surgical periodontal treatment |
| Brochure-Male-11/13 | Active comparator | Male 11-13 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment Receives: Other: Non-surgical periodontal treatment |
| Model-Female-11/13 | Active comparator | Female 11-13 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment Receives: Other: Non-surgical periodontal treatment |
| Model-Male-11/13 | Active comparator | Male 11-13 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment Receives: Other: Non-surgical periodontal treatment |
| Video-Female-11/13 | Active comparator | Female 11-13 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment Receives: Other: Non-surgical periodontal treatment |
| Video-Male-11/13 | Active comparator | Male 11-13 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment Receives: Other: Non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Theoretical Test Application
The changes in theoretical test scores after education
Measured: Baseline and 6 months after treatment
Secondary outcomes (3)
Gingival index
The changes in gingival index after education
Measured: Baseline and 6 months after treatment
Plaque index
The changes in plaque index after education
Measured: Baseline and 6 months after treatment
Bleeding on probing
The changes in bleeding on probing after education
Measured: Baseline and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umut BALLI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Umut BALLI, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989233
- Sponsor's protocol ID
- 36290600/93
- Status last verified
- Dec 2016
- First submitted
- 8 Dec 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Three Different Education Methods on Oral Hygiene and Theoretical Knowledge of Schoolchildren
- ClinicalTrials.gov ID
- NCT02989233
- Acronym / sponsor ID
- 36290600/93
- Conditions
- Oral Hygiene
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Umut BALLIUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Dec 2016 (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.
In the present study, 144 children (72 males and 72 females), whose ages ranged between 8-13, were divided into 12 equal experimental groups according to their ages and gender. They were all considered to have poor hygiene. Only one out of the three different education methods (brochure, model or video) was applied to each group. The percentage change in PI, GI, BOP and theoretical test points from the baseline to the 6th months were evaluated.
Detailed description
Aim: The aim the present study was to evaluate the impact of three different education methods on the oral hygiene levels of school children using clinical and theoretical findings.
Methods: In the present study, 144 children (72 males and 72 females), whose ages ranged between 8-13, were divided into 12 equal experimental groups according to their ages and gender. They were all considered to have poor hygiene. Only one out of the three different education methods (brochure, model or video) was applied to each group. The percentage change in PI, GI, BOP and theoretical test points from the baseline to the 6th months were evaluated. The data was statistically analysed by using Kolmogorov-Smirnov and One-way ANOVA tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Brochure-Female-8/10 | Active comparator | Other: Non-surgical periodontal treatmentFemale 8-10 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment |
| Brochure-Male-8/10 | Active comparator | Other: Non-surgical periodontal treatmentMale 8-10 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment |
| Model-Female-8/10 | Active comparator | Other: Non-surgical periodontal treatmentFemale 8-10 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment |
| Model-Male-8/10 | Active comparator | Other: Non-surgical periodontal treatmentMale 8-10 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment |
| Video-Female-8/10 | Active comparator | Other: Non-surgical periodontal treatmentFemale 8-10 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment |
| Video-Male-8/10 | Active comparator | Other: Non-surgical periodontal treatmentMale 8-10 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment |
| Brochure-Female-11/13 | Active comparator | Other: Non-surgical periodontal treatmentFemale 11-13 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment |
| Brochure-Male-11/13 | Active comparator | Other: Non-surgical periodontal treatmentMale 11-13 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment |
| Model-Female-11/13 | Active comparator | Other: Non-surgical periodontal treatmentFemale 11-13 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment |
| Model-Male-11/13 | Active comparator | Other: Non-surgical periodontal treatmentMale 11-13 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment |
| Video-Female-11/13 | Active comparator | Other: Non-surgical periodontal treatmentFemale 11-13 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment |
| Video-Male-11/13 | Active comparator | Other: Non-surgical periodontal treatmentMale 11-13 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- According to the Simplified Oral Hygiene Index, the patients having the score of 2 and over were accepted.
Key exclusion criteria (1 listed)
- According to the Simplified Oral Hygiene Index, the patients having the score under 2 were not included in the study
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 |
|---|---|---|
| Non-surgical periodontal treatmentScaling and oral hygiene instructions with brochure, model or video | Other | Brochure-Female-11/13, Brochure-Female-8/10, Brochure-Male-11/13, Brochure-Male-8/10, Model-Female-11/13, Model-Female-8/10, Model-Male-11/13, Model-Male-8/10, Video-Female-11/13, Video-Female-8/10, Video-Male-11/13, Video-Male-8/10 |
Primary outcome
Theoretical Test Application
Time frame: Baseline and 6 months after treatment
The changes in theoretical test scores after education
3 secondary outcomes
Gingival index
Time frame: Baseline and 6 months after treatment
Plaque index
Time frame: Baseline and 6 months after treatment
Bleeding on probing
Time frame: Baseline and 6 months after treatment
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 13 Dec 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Non-surgical periodontal treatment in people with Oral Hygiene, run by Umut BALLI.
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 1 inclusion and 1 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 13 Dec 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Theoretical Test Application (time frame: Baseline and 6 months after treatment). 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 13 Dec 2016.