Dental PlaqueNCT06164496
Evaluation of the Effectiveness of Different Toothbrushes in Children
A study testing standart manual toothbrush and 360 degree toothbrush in people with Dental Plaque and Plaque, Dental, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Control groups will be formed in the 2-12 age group using standard manual toothbrushes, and the effectiveness of 360-degree bristle toothbrushes will be compared. Study design: Experimental study Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Plaque, Dental, Oral Hygiene
- What is being tested?
- standart manual toothbrush and 360 degree toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2023to 20 Jan 2024
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 2-12.
- Children without systemic disease or developmental dental anomalies.
- Children not undergoing orthodontic treatment.
- Children with no decay on the labial surfaces of upper anterior incisors.
- Patients or their parents accepting participation in the treatment.
Who cannot join
- Children with decay on the labial surfaces of upper anterior incisors.
- Children undergoing orthodontic treatment.
- Children who, along with their parents, do not agree to participate in the treatment will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University
Maltepe, Istanbul
Başak Durmuş, Prof., +9005353651046, altinokbasak@yahoo.com
Betül Kargül, Prof.
About this study
Official title: Evaluating the Effectiveness of Different Toothbrushes in Children
Control groups will be formed in the 2-12 age group using standard manual toothbrushes, and the effectiveness of 360-degree bristle toothbrushes will be compared.
Study design: Experimental study
Read the detailed description
In this randomized controlled, single-brushing study, children were assigned to a treatment sequence involving a 360-degree toothbrush and a control brush.
Subjects were randomly assigned to a treatment sequence involving a 360-degree toothbrush and a classical manual control toothbrush. Parents brushed the teeth of their children aged 2-5 years, whereas children aged 6-12 years brushed their own teeth under the supervision of clinic staff, unaided by a mirror. Clinical examination of each participant was carried out by the principal investigator. Assessments were done pre- and post-brushing using the "Silness and Löe Plaque Index" (PI), Gingival Index (GI), and the Simplified Oral Hygiene Index (OHI-S). Plaque indices were expressed as means and standard deviations (SD). Within each toothbrush group, the follow-up scores were analyzed using a paired t-test. p < 0.05 was considered statistically significant.
- Conditions
- Dental Plaque, Plaque, Dental, Oral Hygiene, Gingivitis, Periodontal Indexes
- Being tested
- standart manual toothbrush, 360 degree toothbrush
- Medical subject headings
- Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standart manual toothbrushDevice
Device on plaque removal efficacy
360 degree toothbrushDevice
Device on plaque removal efficacy
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | A control group will be formed using a manual brush with a classic head. Receives: Device: standart manual toothbrush |
| study group | Experimental | A study group will be formed using a 360-degree bristle brush. Receives: Device: 360 degree toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal
Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start20 Nov 2023
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Jan 2024 (estimated)
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 Dental PlaqueStudies of the same condition, open and under way.
- More trials run by Marmara 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
- single blinded randomized control trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164496
- Sponsor's protocol ID
- 27.11.2023
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Sivet EA, Atmaca N, Niyazova H, Yilmaz A, Durmus B, Kargul B. Comparative Effectiveness of a 360-Degree Round-Head Toothbrush and a Conventional Manual Toothbrush Among Children: A Randomized Controlled Trial. Int J Dent Hyg. 2026 May 17. doi: 10.1111/idh.70093. Online ahead of print.
PubMed 42143742
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Different Toothbrushes in Children
- ClinicalTrials.gov ID
- NCT06164496
- Acronym / sponsor ID
- 27.11.2023
- Conditions
- Dental Plaque, Plaque, Dental, Oral Hygiene, Gingivitis, Periodontal Indexes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Jan 2024 (estimated)
- First posted
- 11 Dec 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.
Control groups will be formed in the 2-12 age group using standard manual toothbrushes, and the effectiveness of 360-degree bristle toothbrushes will be compared.
Study design: Experimental study
Detailed description
In this randomized controlled, single-brushing study, children were assigned to a treatment sequence involving a 360-degree toothbrush and a control brush.
Subjects were randomly assigned to a treatment sequence involving a 360-degree toothbrush and a classical manual control toothbrush. Parents brushed the teeth of their children aged 2-5 years, whereas children aged 6-12 years brushed their own teeth under the supervision of clinic staff, unaided by a mirror. Clinical examination of each participant was carried out by the principal investigator. Assessments were done pre- and post-brushing using the "Silness and Löe Plaque Index" (PI), Gingival Index (GI), and the Simplified Oral Hygiene Index (OHI-S). Plaque indices were expressed as means and standard deviations (SD). Within each toothbrush group, the follow-up scores were analyzed using a paired t-test. p < 0.05 was considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- single blinded randomized control trial
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Device: standart manual toothbrushA control group will be formed using a manual brush with a classic head. |
| study group | Experimental | Device: 360 degree toothbrushA study group will be formed using a 360-degree bristle brush. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children aged 2-12.
- Children without systemic disease or developmental dental anomalies.
- Children not undergoing orthodontic treatment.
- Children with no decay on the labial surfaces of upper anterior incisors.
- Patients or their parents accepting participation in the treatment.
Key exclusion criteria (3 listed)
- Children with decay on the labial surfaces of upper anterior incisors.
- Children undergoing orthodontic treatment.
- Children who, along with their parents, do not agree to participate in the treatment will be excluded from 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 |
|---|---|---|
| standart manual toothbrushDevice on plaque removal efficacy | Device | control group |
| 360 degree toothbrushDevice on plaque removal efficacy | Device | study group |
Primary outcome
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal
Time frame: 2 weeks
Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Derived from this study: PubMed 42143742Sivet EA, Atmaca N, Niyazova H, Yilmaz A, Durmus B, Kargul B. Comparative Effectiveness of a 360-Degree Round-Head Toothbrush and a Conventional Manual Toothbrush Among Children: A Randomized Controlled Trial. Int J Dent Hyg. 2026 May 17. doi: 10.1111/idh.70093. Online ahead of print.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standart manual toothbrush and 360 degree toothbrush in people with Dental Plaque and Plaque, Dental, run by Marmara 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 3 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 21 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal (time frame: 2 weeks). 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 NCT06164496, 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 21 Dec 2023.