Comparison of Plaque Removal Efficacy of Different Toothbrushes in Clear Aligner Patients

NCT07383636 | Completed

• 1 other identifier: 2024/1110
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dental Plaque Accumulation; Oral Hygiene in Orthodontic Patients; Clear Aligner Therapy

Keywords

Clear aligner; Orthodontic attachments; Dental plaque; Plaque index; Oral hygiene; Manual toothbrush; Powered toothbrush; Plaque removal; Orthodontic patients

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately before and immediately after a single 2-minute toothbrushing session

Study Arms (2)

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.

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.

Device: Powered Toothbrush

Interventions

Manual Toothbrush DEVICE

Use of a manual toothbrush for plaque removal in patients undergoing clear aligner therapy.

Also known as: TePe Select™ Medium

Manual Toothbrush Group

Powered Toothbrush DEVICE

Use of a powered toothbrush for plaque removal in patients undergoing clear aligner therapy.

Also known as: Oral-B iO 9, Electric toothbrush

Powered Toothbrush Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Age \< 18 years
• Absence of attachments on teeth
• Presence of any systemic disease
• Regular use of systemic medications
• Left-handed or ambidextrous individuals

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University, Faculty of Dentistry, Department of Orthodontics

Mersin, Mersin, 33150, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Kübra Arslan Çarpar, DDS, PhD

  Mersin University, Faculty of Dentistry, Department of Orthodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study; no participants, investigators, care providers, or outcome assessors were masked.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Orthodontics, Faculty of Dentistry

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: November 3, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)