Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances

NCT05851963 | Recruiting DMC

• 1 other identifier: ORTHO-IOP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

toothbrush; oral prophylaxis; adolescents; orthodontic appliances

Outcome Measures

Primary Outcomes (1)

• Incidence of gingival bleeding from baseline during orthodontic treatment

  Change of gingival inflammation in patients with fixed orthodontic appliances using manual or electric toothbrushes in daily practice

  T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)

Secondary Outcomes (9)

• Acceptability

  T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)

• Effect on gingival inflammation

  T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)

• Effect on gingival bleeding

  T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)

• Effect on dental plaque

  T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)

• Effect on gingival tissue

  T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)

Study Arms (4)

Group using sonic toothbrush

EXPERIMENTAL

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

Device: Sonicare Diamond Clean 9000

Group using hydrosonic toothbrush

EXPERIMENTAL

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

Device: HydroSonic Pro

Group using manual toothbrush

PLACEBO COMPARATOR

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

Device: Oral-B 123

Group using manual toothbrush with 5460 strands

EXPERIMENTAL

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

Device: Curaprox CS 5460

Interventions

Sonicare Diamond Clean 9000 DEVICE

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

Group using sonic toothbrush

HydroSonic Pro DEVICE

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

Group using hydrosonic toothbrush

Oral-B 123 DEVICE

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

Group using manual toothbrush

Curaprox CS 5460 DEVICE

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

Group using manual toothbrush with 5460 strands

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children to be treated with fixed upper and lower braces
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nancy: collaborator
• Claude Bernard University: lead

Study Sites (1)

Centre de soin dentaire

Nancy, France

RECRUITING

Central Study Contacts

Florence Carrouel, PhD

CONTACT

0478785745; florence.carrouel@univ-lyon1.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Parallel Assignment This trial is designed as an four-arm parallel cluster randomized controlled trial and an allocation ratio of 1:1:1:1

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 10, 2023
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 26, 2026
• Study Completion (Estimated): December 20, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)