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ORTHO-IOP: Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances

Sponsor
Claude Bernard University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05851963
Collaborator
University of Nancy (Other)
120
Enrollment
4
Arms
36.6
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Sonicare Diamond Clean 9000
  • Device: HydroSonic Pro
  • Device: Oral-B 123
  • Device: Curaprox CS 5460
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel Assignment This trial is designed as an four-arm parallel cluster randomized controlled trial and an allocation ratio of 1:1:1:1Parallel Assignment This trial is designed as an four-arm parallel cluster randomized controlled trial and an allocation ratio of 1:1:1:1
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Comparison of the Effectiveness of Manual and Electric Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Mar 20, 2024
Anticipated Study Completion Date :
Sep 20, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group using sonic toothbrush

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

Device: Sonicare Diamond Clean 9000
Brush teeth with the electric toothbrush 1 daily during the orthodontic treatment
Experimental: Group using hydrosonic toothbrush

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

Device: HydroSonic Pro
Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment
Placebo Comparator: Group using manual toothbrush

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

Device: Oral-B 123
Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment
Experimental: Group using manual toothbrush with 5460 strands

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

Device: Curaprox CS 5460
Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment

Outcome Measures

Primary Outcome Measures

  1. Incidence of gingival bleeding from baseline during orthodontic treatment [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 Outcome Measures

  1. Acceptability [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 [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 [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Claude Bernard University
  • University of Nancy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carrouel Florence, Associate professor, Claude Bernard University
ClinicalTrials.gov Identifier:
NCT05851963
Other Study ID Numbers:
  • ORTHO-IOP
First Posted:
May 10, 2023
Last Update Posted:
May 10, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Carrouel Florence, Associate professor, Claude Bernard University
toothbrush
oral prophylaxis
adolescents
orthodontic appliances

Study Results

No Results Posted as of May 10, 2023