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NCT Number: NCT05851963

Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances

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.

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Key information

Conditions

Dental Malposition

Age range

11 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de soin dentaire

Nancy, France

Location status: Recruiting

Location contact

Céline Clément

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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)

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

Secondary outcomes

  1. 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)

    Questionnaire to assess the acceptability of oral hygiene products by patients

  2. 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)

    gingival index

  3. 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)

    Bleeding on Probing

  4. 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)

    plaque index

  5. 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)

    micro-osteoperforation

  6. 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)

    clinical attachment loss

  7. 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)

    Assess the incidence of initial enamel lesions

  8. 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)

    Assess the incidence of dentinal hypersensitivity

  9. 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)

    Measure of pH

Study contacts

Contact information is provided by the study sponsor or research team.

Florence Carrouel, PhD

CONTACT

[email protected]

0478785745 ext. +33

Sponsors and collaborators

Lead sponsor

Claude Bernard University

Other

Collaborators

  • University of Nancy

Registry information

Official study title

Comparison of the Effectiveness of Manual and Electric Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances

Acronym: ORTHO-IOP

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 10, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.