Dental Plaque AccumulationNCT07383636
Comparison of Plaque Removal Efficacy of Different Toothbrushes in Clear Aligner Patients
A study testing Manual Toothbrush and Powered Toothbrush in people with Dental Plaque Accumulation and Oral Hygiene in Orthodontic Patients, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effectiveness of manual and powered toothbrushes in removing dental plaque in patients undergoing clear aligner orthodontic treatment. Clear aligner treatment uses attachments bonded to teeth to facilitate tooth movement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque Accumulation, Oral Hygiene in Orthodontic Patients, Clear Aligner Therapy
- What is being tested?
- Manual Toothbrush and Powered Toothbrush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Nov 2025to 31 Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Undergoing orthodontic treatment with clear aligners
- Presence of bonded attachments on teeth
- No known systemic diseases
- Not using any regular systemic medications
- Right-handed individuals (actively using the right hand)
Who cannot join
- Age < 18 years
- Absence of attachments on teeth
- Presence of any systemic disease
- Regular use of systemic medications
- Left-handed or ambidextrous individuals
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin University, Faculty of Dentistry, Department of Orthodontics
Mersin, Mersin, 33150
About this study
Official title: Comparison of the Plaque Removal Efficacy of Manual and Powered Toothbrushes in Patients Undergoing Clear Aligner Therapy
This study aims to compare the effectiveness of manual and powered toothbrushes in removing dental plaque in patients undergoing clear aligner orthodontic treatment.
Clear aligner treatment uses attachments bonded to teeth to facilitate tooth movement. These attachments may increase plaque accumulation around the tooth surface. Poor plaque control can lead to dental caries and periodontal problems.
Read more
In this study, patients receiving clear aligner treatment will brush their teeth using either a manual or a powered toothbrush. Dental plaque levels around attachments will be evaluated before and after brushing using a modified plaque index.
The results of this study may help determine whether one type of toothbrush is more effective than the other in maintaining oral hygiene during clear aligner therapy.
Read the detailed description
Dental plaque is a complex biofilm and a primary etiological factor in the development of dental caries and periodontal diseases. Orthodontic treatments may increase plaque accumulation due to the presence of attachments bonded to the tooth surface.
Clear aligner therapy has become increasingly popular due to its esthetic and removable nature. However, attachments used during treatment may compromise oral hygiene by promoting plaque retention, particularly in the gingival region.
This study is designed to evaluate and compare the plaque removal effectiveness of manual and powered toothbrushes in patients undergoing clear aligner orthodontic treatment.
A total of 14 patients receiving clear aligner therapy will be randomly assigned to either a manual toothbrush group or a powered toothbrush group. Dental plaque accumulation around attachments will be assessed before brushing (T0) and after a standardized two-minute brushing period (T1) using the Modified Plaque Index adapted for orthodontic patients.
Plaque scores will be evaluated at multiple tooth surfaces (mesial, distal, occlusal, and gingival) and analyzed both on a patient-based and tooth-based level. Attachments will also be categorized as conventional or optimized, and plaque reduction will be compared between attachment types.
The findings of this study are expected to provide evidence regarding the effectiveness of different toothbrush types in maintaining oral hygiene in patients treated with clear aligners.
- Being tested
- Manual Toothbrush, Powered Toothbrush
- Keywords
- Clear aligner, Orthodontic attachments, Dental plaque, Plaque index, Oral hygiene, Manual toothbrush, Powered toothbrush, Plaque removal, Orthodontic patients
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual ToothbrushDevice
Also called TePe Select™ Medium
Use of a manual toothbrush for plaque removal in patients undergoing clear aligner therapy.
Powered ToothbrushDevice
Also called Oral-B iO 9, Electric toothbrush
Use of a powered toothbrush for plaque removal in patients undergoing clear aligner therapy.
| Study group | Role | What they receive |
|---|---|---|
| Manual Toothbrush Group | Experimental | Participants brushed their teeth for 2 minutes using a manual toothbrush following standardized oral hygiene instructions during a routine orthodontic visit. Receives: Device: Manual Toothbrush |
| Powered Toothbrush Group | Experimental | Participants brushed their teeth for 2 minutes using a powered toothbrush following standardized oral hygiene instructions during a routine orthodontic visit. Receives: Device: Powered Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Plaque Index (MPI) Score After Toothbrushing
The primary outcome is the change in dental plaque accumulation measured using the Modified Plaque Index (MPI). Plaque scores will be recorded immediately before toothbrushing (T0) and immediately after a standardized 2-minute toothbrushing session (T1). The difference between T0 and T1 MPI scores will be calculated to assess plaque removal effectiveness.
Measured: Immediately before and immediately after a single 2-minute toothbrushing session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start3 Nov 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Plaque AccumulationStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel groups: a manual toothbrush group or an electronic toothbrush group. Each participant received only the allocated intervention, and plaque scores were evaluated before and after a single supervised brushing session.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Arslan Çarpar, Mersin University
- Investigators
- Kübra Arslan Çarpar, DDS, PhD, Principal investigator, Mersin University, Faculty of Dentistry, Department of Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383636
- Sponsor's protocol ID
- 2024/1110
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the small sample size of the study and the potential risk of participant re-identification. Additionally, the informed consent obtained from participants did not include provisions for data sharing beyond the scope of the present study.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Plaque Removal Efficacy of Manual and Powered Toothbrushes in Patients Undergoing Clear Aligner Therapy
- ClinicalTrials.gov ID
- NCT07383636
- Acronym / sponsor ID
- 2024/1110
- Keywords
- Clear aligner, Orthodontic attachments, Dental plaque, Plaque index, Oral hygiene, Manual toothbrush, Powered toothbrush, Plaque removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 3 Feb 2026 (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 study aims to compare the effectiveness of manual and powered toothbrushes in removing dental plaque in patients undergoing clear aligner orthodontic treatment.
Clear aligner treatment uses attachments bonded to teeth to facilitate tooth movement. These attachments may increase plaque accumulation around the tooth surface. Poor plaque control can lead to dental caries and periodontal problems.
In this study, patients receiving clear aligner treatment will brush their teeth using either a manual or a powered toothbrush. Dental plaque levels around attachments will be evaluated before and after brushing using a modified plaque index.
The results of this study may help determine whether one type of toothbrush is more effective than the other in maintaining oral hygiene during clear aligner therapy.
Detailed description
Dental plaque is a complex biofilm and a primary etiological factor in the development of dental caries and periodontal diseases. Orthodontic treatments may increase plaque accumulation due to the presence of attachments bonded to the tooth surface.
Clear aligner therapy has become increasingly popular due to its esthetic and removable nature. However, attachments used during treatment may compromise oral hygiene by promoting plaque retention, particularly in the gingival region.
This study is designed to evaluate and compare the plaque removal effectiveness of manual and powered toothbrushes in patients undergoing clear aligner orthodontic treatment.
A total of 14 patients receiving clear aligner therapy will be randomly assigned to either a manual toothbrush group or a powered toothbrush group. Dental plaque accumulation around attachments will be assessed before brushing (T0) and after a standardized two-minute brushing period (T1) using the Modified Plaque Index adapted for orthodontic patients.
Plaque scores will be evaluated at multiple tooth surfaces (mesial, distal, occlusal, and gingival) and analyzed both on a patient-based and tooth-based level. Attachments will also be categorized as conventional or optimized, and plaque reduction will be compared between attachment types.
The findings of this study are expected to provide evidence regarding the effectiveness of different toothbrush types in maintaining oral hygiene in patients treated with clear aligners.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups: a manual toothbrush group or an electronic toothbrush group. Each participant received only the allocated intervention, and plaque scores were evaluated before and after a single supervised brushing session.
| Arm | Type | Receives |
|---|---|---|
| Manual Toothbrush Group | Experimental | Device: Manual ToothbrushParticipants brushed their teeth for 2 minutes using a manual toothbrush following standardized oral hygiene instructions during a routine orthodontic visit. |
| Powered Toothbrush Group | Experimental | Device: Powered ToothbrushParticipants brushed their teeth for 2 minutes using a powered toothbrush following standardized oral hygiene instructions during a routine orthodontic visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Undergoing orthodontic treatment with clear aligners
- Presence of bonded attachments on teeth
- No known systemic diseases
- Not using any regular systemic medications
Key exclusion criteria (5 listed)
- Age < 18 years
- Absence of attachments on teeth
- Presence of any systemic disease
- Regular use of systemic medications
- Left-handed or ambidextrous individuals
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 |
|---|---|---|
| Manual ToothbrushAlso: TePe Select™ MediumUse of a manual toothbrush for plaque removal in patients undergoing clear aligner therapy. | Device | Manual Toothbrush Group |
| Powered ToothbrushAlso: Oral-B iO 9, Electric toothbrushUse of a powered toothbrush for plaque removal in patients undergoing clear aligner therapy. | Device | Powered Toothbrush Group |
Primary outcome
Change in Modified Plaque Index (MPI) Score After Toothbrushing
Time frame: Immediately before and immediately after a single 2-minute toothbrushing session
The primary outcome is the change in dental plaque accumulation measured using the Modified Plaque Index (MPI). Plaque scores will be recorded immediately before toothbrushing (T0) and immediately after a standardized 2-minute toothbrushing session (T1). The difference between T0 and T1 MPI scores will be calculated to assess plaque removal effectiveness.
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 3 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the small sample size of the study and the potential risk of participant re-identification. Additionally, the informed consent obtained from participants did not include provisions for data sharing beyond the scope of the present study.
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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.
Kübra Arslan Çarpar, DDS, PhD principal investigator
Mersin University, Faculty of Dentistry, Department of Orthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Toothbrush and Powered Toothbrush in people with Dental Plaque Accumulation and Oral Hygiene in Orthodontic Patients, run by Mersin 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 6 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 3 Feb 2026. 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?
Change in Modified Plaque Index (MPI) Score After Toothbrushing (time frame: Immediately before and immediately after a single 2-minute toothbrushing session). 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 3 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.