Oral Hygiene EducationNCT06449950
The Effects of Different Oral Hygiene Instructions
A study testing Behavioral: Verbal Oral Hygiene Instructions and Behavioral: Video-Based Oral Hygiene Instructions in people with Oral Hygiene Education and Oral Hygiene Education Methods, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of verbal and video-based oral hygiene instructions on the oral health parameters in patients of different age groups. 202 patients in 6-9 and 10-12 aged (n=101 and n=101, respectively) were included in the study protocol. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene Education, Oral Hygiene Education Methods
- What is being tested?
- Behavioral: Verbal Oral Hygiene Instructions and Behavioral: Video-Based Oral Hygiene Instructions
- 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
- 202 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 12 Sep 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-9 years or 10-12 years
- Children who were medically free of chronic/systemic conditions
- Patients without physical or mental disabilities or syndromes
- Patients without motor dysfunction diseases
- Patients whose permanent central incisor and permanent first molar teeth had erupted and had not been extracted for any reason
Who cannot join
- Children aged <6 or >12 years
- Children with chronic/systemic conditions
- Patients with physical or mental disabilities or syndromes
- Patients with motor dysfunction diseases
- Patients whose permanent central incisor and permanent first molar teeth had not erupted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of the Effects of Verbal and Video-Based Instructions on the Improvement of Oral Hygiene Status in Children: A Randomized Clinical Trial
The aim of this study is to evaluate the effects of verbal and video-based oral hygiene instructions on the oral health parameters in patients of different age groups. 202 patients in 6-9 and 10-12 aged (n=101 and n=101, respectively) were included in the study protocol. Before oral hygiene instructions, baseline oral g of all patients were determined using Simplified Oral Hygiene Index (OHI-S). Within each age group, approximately half of the participants randomly assigned to verbal (n=50 for 6-9 ages, n=51 for 10-12 ages) and video-based OHI (n=51 for 6-9 ages, n=50 for 10-12 ages). Patients were re-called for after 30 days and final OHI-S scores were recorded.
Read the detailed description
In pediatric dentistry, preventive dental approaches are essential in providing sustainable oral health of children. Despite all the preventive applications, dental caries is still an important public health problem affecting preschool and school children. Oral hygiene education has an important role on the dental health services. This aims to increase awareness of oral health, provide information about it and encourage individuals to maintain oral health. Based on, the current study aims to evaluate the effects of verbal and video-based oral hygiene instructions on the oral health parameters in patients of different age groups. 202 patients in 6-9 and 10-12 aged (n=101 and n=101, respectively) were included in the study protocol. Before oral hygiene instructions, baseline oral g of all patients were determined using Simplified Oral Hygiene Index (OHI-S). Within each age group, approximately half of the participants randomly assigned to verbal (n=50 for 6-9 ages, n=51 for 10-12 ages) and video-based OHI (n=51 for 6-9 ages, n=50 for 10-12 ages). Patients were re-called for after 30 days and final OHI-S scores were recorded. Data were analysed with Shapiro-Wilk, Mann-Whitney U and Wilcoxon Signed Rank tests. Statistical significance level was considered as 5%.
- Being tested
- Behavioral: Verbal Oral Hygiene Instructions, Behavioral: Video-Based Oral Hygiene Instructions
- Keywords
- Oral health education, Oral hygiene, Pediatric dental patients, Toothbrushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Verbal Oral Hygiene InstructionsBehavioural
OHI-S index scores of patients who received verbal oral hygiene education were measured at baseline and final (in post-education).
Behavioral: Video-Based Oral Hygiene InstructionsBehavioural
OHI-S index scores of patients who received video-based oral hygiene education were measured at baseline and final (in post-education).
| Study group | Role | What they receive |
|---|---|---|
| Verbal Oral Hygiene Instruction Group | Experimental | Verbal oral hygiene instructions were given to the pediatric patients by the instructor using the Bass brushing technique without any training model or visual aids, only with the verbal instructions. Receives: Behavioral: Behavioral: Verbal Oral Hygiene Instructions |
| Video-Based Oral Hygiene Instruction Group | Experimental | The video-based oral hygiene instructions to be delivered to the paediatric dental participants were given by watching a pre-prepared video tape on a tooth and jaw model, using the instructions specified in the verbal education. Receives: Behavioral: Behavioral: Video-Based Oral Hygiene Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simplified Oral Hygiene Index (OHI-S) Scoring
In the present study, 30 days after verbal and video-based oral hygiene instructions were given to patients, oral hygiene status was similarly determined and recorded using OHI-S index method (OHI-S final scores).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Jul 2023
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Hygiene EducationStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Model description
- For each age group (6-9 and 10-12) participants were randomly assigned to verbal and video-based oral hygiene instruction groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akif Demirel, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449950
- Sponsor's protocol ID
- 11/02
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Demirel A, Guclu HS, Guclu M, Bagis N. Evaluation of Effects of Verbal and Video-Based Instructions on the Improvement of Oral Hygiene Status in Children: A Randomised Clinical Trial. Int J Dent Hyg. 2025 Aug;23(3):575-583. doi: 10.1111/idh.12898. Epub 2025 Jan 29.
PubMed 39887898
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effects of Verbal and Video-Based Instructions on the Improvement of Oral Hygiene Status in Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06449950
- Acronym / sponsor ID
- 11/02
- Keywords
- Oral health education, Oral hygiene, Pediatric dental patients, Toothbrushing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 10 Jun 2024 (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.
The aim of this study is to evaluate the effects of verbal and video-based oral hygiene instructions on the oral health parameters in patients of different age groups. 202 patients in 6-9 and 10-12 aged (n=101 and n=101, respectively) were included in the study protocol. Before oral hygiene instructions, baseline oral g of all patients were determined using Simplified Oral Hygiene Index (OHI-S). Within each age group, approximately half of the participants randomly assigned to verbal (n=50 for 6-9 ages, n=51 for 10-12 ages) and video-based OHI (n=51 for 6-9 ages, n=50 for 10-12 ages). Patients were re-called for after 30 days and final OHI-S scores were recorded.
Detailed description
In pediatric dentistry, preventive dental approaches are essential in providing sustainable oral health of children. Despite all the preventive applications, dental caries is still an important public health problem affecting preschool and school children. Oral hygiene education has an important role on the dental health services. This aims to increase awareness of oral health, provide information about it and encourage individuals to maintain oral health. Based on, the current study aims to evaluate the effects of verbal and video-based oral hygiene instructions on the oral health parameters in patients of different age groups. 202 patients in 6-9 and 10-12 aged (n=101 and n=101, respectively) were included in the study protocol. Before oral hygiene instructions, baseline oral g of all patients were determined using Simplified Oral Hygiene Index (OHI-S). Within each age group, approximately half of the participants randomly assigned to verbal (n=50 for 6-9 ages, n=51 for 10-12 ages) and video-based OHI (n=51 for 6-9 ages, n=50 for 10-12 ages). Patients were re-called for after 30 days and final OHI-S scores were recorded. Data were analysed with Shapiro-Wilk, Mann-Whitney U and Wilcoxon Signed Rank tests. Statistical significance level was considered as 5%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- For each age group (6-9 and 10-12) participants were randomly assigned to verbal and video-based oral hygiene instruction groups.
| Arm | Type | Receives |
|---|---|---|
| Verbal Oral Hygiene Instruction Group | Experimental | Behavioral: Behavioral: Verbal Oral Hygiene InstructionsVerbal oral hygiene instructions were given to the pediatric patients by the instructor using the Bass brushing technique without any training model or visual aids, only with the verbal instructions. |
| Video-Based Oral Hygiene Instruction Group | Experimental | Behavioral: Behavioral: Video-Based Oral Hygiene InstructionsThe video-based oral hygiene instructions to be delivered to the paediatric dental participants were given by watching a pre-prepared video tape on a tooth and jaw model, using the instructions specified in the verbal education. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 6-9 years or 10-12 years
- Children who were medically free of chronic/systemic conditions
- Patients without physical or mental disabilities or syndromes
- Patients without motor dysfunction diseases
- Patients whose permanent central incisor and permanent first molar teeth had erupted and had not been extracted for any reason
Key exclusion criteria (5 listed)
- Children aged <6 or >12 years
- Children with chronic/systemic conditions
- Patients with physical or mental disabilities or syndromes
- Patients with motor dysfunction diseases
- Patients whose permanent central incisor and permanent first molar teeth had not erupted
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 |
|---|---|---|
| Behavioral: Verbal Oral Hygiene InstructionsOHI-S index scores of patients who received verbal oral hygiene education were measured at baseline and final (in post-education). | Behavioural | Verbal Oral Hygiene Instruction Group |
| Behavioral: Video-Based Oral Hygiene InstructionsOHI-S index scores of patients who received video-based oral hygiene education were measured at baseline and final (in post-education). | Behavioural | Video-Based Oral Hygiene Instruction Group |
Primary outcome
Simplified Oral Hygiene Index (OHI-S) Scoring
Time frame: 30 days
In the present study, 30 days after verbal and video-based oral hygiene instructions were given to patients, oral hygiene status was similarly determined and recorded using OHI-S index method (OHI-S final scores).
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 Jun 2024.
- Derived from this study: PubMed 39887898Demirel A, Guclu HS, Guclu M, Bagis N. Evaluation of Effects of Verbal and Video-Based Instructions on the Improvement of Oral Hygiene Status in Children: A Randomised Clinical Trial. Int J Dent Hyg. 2025 Aug;23(3):575-583. doi: 10.1111/idh.12898. Epub 2025 Jan 29.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Verbal Oral Hygiene Instructions and Behavioral: Video-Based Oral Hygiene Instructions in people with Oral Hygiene Education and Oral Hygiene Education Methods, run by Ankara University at 1 site 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 5 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: finished, as of the sponsor's last update on 10 Jun 2024. 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 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?
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?
Simplified Oral Hygiene Index (OHI-S) Scoring (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06449950, which also lists 1 linked publication.
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 Jun 2024.