Plaque, DentalNCT06594757
Plaque Removal by Triple-Headed Manual Toothbrush
A study testing Toothbrushing with triple-headed manual toothbrush and Toothbrushing with standard manual toothbrush in people with Plaque, Dental, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aimed to determine the effectiveness of a plaque removal by triple-headed manual toothbrush by comparing changes in Rustogi Modifiye Navy Plaque Index. Participants will be divided into two groups and will be made to brush with different designed toothbrushes. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque, Dental
- What is being tested?
- Toothbrushing with triple-headed manual toothbrush and Toothbrushing with standard manual toothbrush
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Dec 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age ranging from 18-60 years;
- a minimum of 12 teeth;
- participants were wanted to be right-handers when toothbrushing to standardization.
Who cannot join
- Patients with systemic illnesses or conditions,
- smokers and individuals taking any medication that may affect periodontal health were not included in the study.
- Individuals who had previously been treated for periodontal disease in the past 6 months were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Plaque Removal by Triple-Headed Manual Toothbrush: A Randomized Controlled Clinical Trial
This randomized controlled trial aimed to determine the effectiveness of a plaque removal by triple-headed manual toothbrush by comparing changes in Rustogi Modifiye Navy Plaque Index.
Participants will be divided into two groups and will be made to brush with different designed toothbrushes.
The researchers will compare the plaque removal efficiency of the brushes by comparing the changes in the plaque index of the intervention and control groups before and after brushing.
- Conditions
- Plaque, Dental
- Being tested
- Toothbrushing with triple-headed manual toothbrush, Toothbrushing with standard manual toothbrush
- Keywords
- oral hygiene, Rustogi Modifiye Navy Plaque Index, Modified Bass Technique, toothbrush, dental plaque
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothbrushing with triple-headed manual toothbrushProcedure or surgery
Toothbrushing with triple-headed manual toothbrush
Toothbrushing with standard manual toothbrushProcedure or surgery
Toothbrushing with tstandard manual toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Standart Manual Toothbrush (SMB) | Active comparator | Conventional toothbrushing with standart manual toothbrush Receives: Procedure: Toothbrushing with standard manual toothbrush |
| Triple-Headed Manual Toothbrush (3HB) | Experimental | Toothbrushing with triple-headed manual toothbrush Receives: Procedure: Toothbrushing with triple-headed manual toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rustogi Modifiye Navy Plaque Index
The amount of plaque present on the teeth was assessed using a plaque staining agent and graded according to the plaque index system. Higher scores mean a worse outcome.
Measured: 1 minute before brushing
Rustogi Modifiye Navy Plaque Index
The amount of plaque present on the teeth was assessed using a plaque staining agent and graded according to the plaque index system. Higher scores mean a worse outcome.
Measured: 1 minute after brushing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque, DentalStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem OZKAL EMINOGLU, Ataturk University
- Investigators
- Didem Özkal Eminoğlu, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594757
- Sponsor's protocol ID
- TSA-2023-13318
- Status last verified
- Jan 2025
- First submitted
- 9 Sep 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Plaque Removal by Triple-Headed Manual Toothbrush: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06594757
- Acronym / sponsor ID
- TSA-2023-13318
- Conditions
- Plaque, Dental
- Keywords
- oral hygiene, Rustogi Modifiye Navy Plaque Index, Modified Bass Technique, toothbrush, dental plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 19 Sep 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.
This randomized controlled trial aimed to determine the effectiveness of a plaque removal by triple-headed manual toothbrush by comparing changes in Rustogi Modifiye Navy Plaque Index.
Participants will be divided into two groups and will be made to brush with different designed toothbrushes.
The researchers will compare the plaque removal efficiency of the brushes by comparing the changes in the plaque index of the intervention and control groups before and after brushing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standart Manual Toothbrush (SMB) | Active comparator | Procedure: Toothbrushing with standard manual toothbrushConventional toothbrushing with standart manual toothbrush |
| Triple-Headed Manual Toothbrush (3HB) | Experimental | Procedure: Toothbrushing with triple-headed manual toothbrushToothbrushing with triple-headed manual toothbrush |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age ranging from 18-60 years;
- a minimum of 12 teeth;
- participants were wanted to be right-handers when toothbrushing to standardization.
Key exclusion criteria (3 listed)
- Patients with systemic illnesses or conditions,
- smokers and individuals taking any medication that may affect periodontal health were not included in the study.
- Individuals who had previously been treated for periodontal disease in the past 6 months were also excluded.
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 |
|---|---|---|
| Toothbrushing with triple-headed manual toothbrushToothbrushing with triple-headed manual toothbrush | Procedure or surgery | Triple-Headed Manual Toothbrush (3HB) |
| Toothbrushing with standard manual toothbrushToothbrushing with tstandard manual toothbrush | Procedure or surgery | Standart Manual Toothbrush (SMB) |
Primary outcome
Rustogi Modifiye Navy Plaque Index
Time frame: 1 minute before brushing
The amount of plaque present on the teeth was assessed using a plaque staining agent and graded according to the plaque index system. Higher scores mean a worse outcome.
Rustogi Modifiye Navy Plaque Index
Time frame: 1 minute after brushing
The amount of plaque present on the teeth was assessed using a plaque staining agent and graded according to the plaque index system. Higher scores mean a worse outcome.
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 28 Jan 2025.
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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.
Didem Özkal Eminoğlu study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothbrushing with triple-headed manual toothbrush and Toothbrushing with standard manual toothbrush in people with Plaque, Dental, run by Ataturk 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 3 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: finished, as of the sponsor's last update on 28 Jan 2025. 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?
Rustogi Modifiye Navy Plaque Index (time frame: 1 minute before brushing). The study lists 2 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 28 Jan 2025; AzTrials last refreshed its copy on 1 Nov 2026.