Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sonicare Diamond Clean 9000, HydroSonic Pro, Oral-B 123, Curaprox CS 5460.
- Who it may be relevant to
- Registry conditions: Dental Malposition. Basic parameters: 11 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of the Effectiveness of Manual and Electric Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances
Overview
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.
Interventions
- Device Sonicare Diamond Clean 9000
Brush teeth with the electric toothbrush 1 daily during the orthodontic treatment - Device HydroSonic Pro
Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment - Device Oral-B 123
Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment - Device Curaprox CS 5460
Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment
Primary outcome measures
- Incidence of gingival bleeding from baseline during orthodontic treatment [Time frame: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)]
Secondary outcome measures (9)
- Acceptability [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 attachment [Time frame: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)]
- Enamel lesions [Time frame: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)]
- Dentinal hypersensitivity [Time frame: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)]
- Salivary acidity [Time frame: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
France · 1 center
- Centre de soin dentaire — Nancy
Identifiers
NCT: NCT05851963 · ORTHO-IOP