- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07383636
Comparison of Plaque Removal Efficacy of Different Toothbrushes in Clear Aligner Patients
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.
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Mersin
-
Mersin, Mersin, Turkey (Türkiye), 33150
- Mersin University, Faculty of Dentistry, Department of Orthodontics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Age < 18 years
- Absence of attachments on teeth
- Presence of any systemic disease
- Regular use of systemic medications
- Left-handed or ambidextrous individuals
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Manual Toothbrush Group
Participants brushed their teeth for 2 minutes using a manual toothbrush following standardized oral hygiene instructions during a routine orthodontic visit.
|
Use of a manual toothbrush for plaque removal in patients undergoing clear aligner therapy.
Other Names:
|
|
Experimental: Powered Toothbrush Group
Participants brushed their teeth for 2 minutes using a powered toothbrush following standardized oral hygiene instructions during a routine orthodontic visit.
|
Use of a powered toothbrush for plaque removal in patients undergoing clear aligner therapy.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Immediately before and immediately after a single 2-minute toothbrushing session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kübra Arslan Çarpar, DDS, PhD, Mersin University, Faculty of Dentistry, Department of Orthodontics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/1110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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