Toothbrushes in Daily Practice in Patients with Fixed Orthodontic Appliances (ORTHO-IOP)

Claude Bernard University

Status: Enrolling

Conditions: Dental Malposition

Treatments: Device: Curaprox CS 5460; Device: Oral-B 123; Device: Sonicare Diamond Clean 9000; Device: HydroSonic Pro

Study type: Interventional

Funder types: Other

Identifiers

NCT05851963

ORTHO-IOP

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 11 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 4 patient groups, including a placebo group

Group using sonic toothbrush

Experimental group

Description:

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

Treatment:

Device: Sonicare Diamond Clean 9000

Group using hydrosonic toothbrush

Experimental group

Description:

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

Treatment:

Device: HydroSonic Pro

Group using manual toothbrush

Placebo Comparator group

Description:

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

Treatment:

Device: Oral-B 123

Group using manual toothbrush with 5460 strands

Experimental group

Description:

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

Treatment:

Device: Curaprox CS 5460