Toothbrushes in Daily Practice in Patients with Fixed Orthodontic Appliances

NCT ID: NCT05851963

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-12-20

Brief Summary

Because of the difficulties of disorganizing the dental biofilm in these adolescents with fixed orthodontic treatment, electric toothbrushes have been proposed as an alternative to manual toothbrushes. Electric toothbrushes, available in a wide range of price points, have been developed with the goal of replicating the complex motions required by the manual toothbrush and making plaque removal more efficient. However, the overall effect size is limited, and the clinical relevance is not yet clear. Applied to orthodontics, specialized manual toothbrushes have also recently been developed. Few recent clinical trials have been conducted in patients with orthodontic appliances.

Thus, the question of whether and which type of manual or electric toothbrushes may be beneficial for patients with orthodontic appliances is still unresolved. Given the variety of toothbrushes available on the market, there is a need for sound clinical research to evaluate their effectiveness to guide professional recommendations. This work will provide a significant advance in the knowledge of the potential of the latest generation of electric toothbrushes on gingival inflammation, potentially reducing the risk of caries and gingival lesions.

Conditions

Dental Malposition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group using sonic toothbrush

Patients will be asked to use a sonic toothbrush for 24 months

Group Type: EXPERIMENTAL

Sonicare Diamond Clean 9000

Intervention Type: DEVICE

Brush teeth with the electric toothbrush 1 daily during the orthodontic treatment

Group using hydrosonic toothbrush

Patients will be asked to use a hydrosonic toothbrush for 24 months

Group Type: EXPERIMENTAL

HydroSonic Pro

Intervention Type: DEVICE

Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment

Group using manual toothbrush

Patients will be asked to use a manual toothbrush for 24 months

Group Type: PLACEBO_COMPARATOR

Oral-B 123

Intervention Type: DEVICE

Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment

Group using manual toothbrush with 5460 strands

Patients will be asked to use a manual toothbrush with 5460 strands for 24 months

Group Type: EXPERIMENTAL

Curaprox CS 5460

Intervention Type: DEVICE

Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment

Interventions

Sonicare Diamond Clean 9000

Brush teeth with the electric toothbrush 1 daily during the orthodontic treatment

Intervention Type: DEVICE

HydroSonic Pro

Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment

Intervention Type: DEVICE

Oral-B 123

Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment

Intervention Type: DEVICE

Curaprox CS 5460

Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Children to be treated with fixed upper and lower braces
• 11 to 15 years of age at the start of treatment
• One parent/legal guardian agrees to the terms and conditions of the study and signs the informed consent form
• The adolescent agrees to the terms and conditions of the study and signs the informed consent form

Exclusion Criteria

• Less than 20 permanent teeth with braces or brackets
• Presence of untreated cavities
• Bleeding greater than 10% on probing
• Presence of a gingival pocket larger than 5 mm
• Presence of fixed prosthetic restorations
• Presence of any enamel development defect
• Presence of dental anomalies or direct/indirect labial restorations on teeth
• Patients requiring orthognathic surgeries
• Presence of systemic diseases (diabetes, hepatic, renal, hematologic, cardiovascular)
• Use of medications that may affect gingival health (such as calcium channel blockers, ciclosporin and anticoagulants)
• Use of antibiotics and anti-inflammatory drugs for any purpose over a long period of time.
• Having a smoking habit
• Having a physical or mental problem that affects manual dexterity
• Being unable to answer questions or being uncooperative

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nancy

OTHER

Sponsor Role: collaborator

Claude Bernard University

OTHER

Sponsor Role: lead

Responsible Party

Carrouel Florence

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre de soin dentaire

Nancy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Florence Carrouel, PhD

Role: CONTACT

florence.carrouel@univ-lyon1.fr

0478785745 ext. +33

Facility Contacts

Céline Clément

Role: primary

Other Identifiers

ORTHO-IOP

Identifier Type: -

Identifier Source: org_study_id