Clinical trial NCT05851963: Toothbrushes in Daily Practice in Patients with Fixed Orthodontic Appliances
Official title: Comparison of the Effectiveness of Manual and Electric Toothbrushes in Daily Practice in Patients with Fixed Orthodontic Appliances
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Malposition
Keywords: toothbrush
oral prophylaxis
adolescents
orthodontic appliances
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
Collaborators: name: University of Nancy
First posted: 2023-05-10
Enrollment: 120
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment This trial is designed as an four-arm parallel cluster randomized controlled trial and an allocation ratio of 1:1:1:1
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incidence of gingival bleeding from baseline during orthodontic treatment
timeFrame: 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:
measure: Acceptability
timeFrame: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)
measure: Effect on gingival inflammation
timeFrame: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)
measure: Effect on gingival bleeding
timeFrame: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)
measure: Effect on dental plaque
timeFrame: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)
measure: Effect on gingival tissue
timeFrame: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)
measure: Effect on gingival attachment
timeFrame: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)
measure: Enamel lesions
timeFrame: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)
measure: Dentinal hypersensitivity
timeFrame: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)
measure: Salivary acidity
timeFrame: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre de soin dentaire
Study officials:
References: