Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-15
SponsorClaude Bernard University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sonicare Diamond Clean 9000

    Device

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

  • HydroSonic Pro

    Device

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

  • Oral-B 123

    Device

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

  • Curaprox CS 5460

    Device

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

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Group using sonic toothbrushExperimental treatment 1 intervention
Group B: Group using hydrosonic toothbrushExperimental treatment 1 intervention
Group C: Group using manual toothbrushPlacebo comparator 1 intervention
Group D: Group using manual toothbrush with 5460 strandsExperimental treatment 1 intervention

Trial outcomes

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

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 outcomes

1

Acceptability

Questionnaire to assess the acceptability of oral hygiene products by patients

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)
2

Effect on gingival inflammation

gingival index

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)
3

Effect on gingival bleeding

Bleeding on Probing

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)
4

Effect on dental plaque

plaque index

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Claude Bernard University

Lead sponsor

University of Nancy

Collaborator