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

Comparison of the Effectiveness of Manual and Electric 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.

Study Overview

• Status: Recruiting
• Conditions: Dental Malposition
• Intervention / Treatment: Device: Sonicare Diamond Clean 9000; Device: HydroSonic Pro; Device: Oral-B 123; Device: Curaprox CS 5460

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florence Carrouel, PhD; Phone Number: +33 0478785745; Email: florence.carrouel@univ-lyon1.fr

Study Locations

• France
  • Nancy, France
    • Recruiting
    • Centre de soin dentaire
    • Contact: Céline Clément

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Outcome Measure	Measure Description	Time Frame
Acceptability	Questionnaire to assess the acceptability of oral hygiene products by patients	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	gingival index	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	Bleeding on Probing	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	plaque index	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	micro-osteoperforation	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	clinical attachment loss	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	Assess the incidence of initial 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)
Dentinal hypersensitivity	Assess the incidence of 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)
Salivary acidity	Measure of pH	T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)

Collaborators and Investigators

• Sponsor: Claude Bernard University
• Collaborators: University of Nancy

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): July 20, 2024
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: adolescents; toothbrush; oral prophylaxis; orthodontic appliances
• Other Study ID Numbers: ORTHO-IOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No