Dental MalpositionORTHO-IOPNCT05851963
Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances
A study testing Sonicare Diamond Clean 9000, HydroSonic Pro and Oral-B 123 in people with Dental Malposition, run by Claude Bernard University at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Malposition
- What is being tested?
- Sonicare Diamond Clean 9000, HydroSonic Pro and Oral-B 123
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2025to 20 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre de soin dentaire
Nancy
Céline Clément
About this study
Official title: 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.
- Conditions
- Dental Malposition
- Being tested
- Sonicare Diamond Clean 9000, HydroSonic Pro, Oral-B 123, Curaprox CS 5460
- Keywords
- toothbrush, oral prophylaxis, adolescents, orthodontic appliances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonicare Diamond Clean 9000Device
Brush teeth with the electric toothbrush 1 daily during the orthodontic treatment
HydroSonic ProDevice
Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment
Oral-B 123Device
Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment
Curaprox CS 5460Device
Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment
| Study group | Role | What they receive |
|---|---|---|
| Group using sonic toothbrush | Experimental | Patients will be asked to use a sonic toothbrush for 24 months Receives: Device: Sonicare Diamond Clean 9000 |
| Group using hydrosonic toothbrush | Experimental | Patients will be asked to use a hydrosonic toothbrush for 24 months Receives: Device: HydroSonic Pro |
| Group using manual toothbrush | Placebo comparator | Patients will be asked to use a manual toothbrush for 24 months Receives: Device: Oral-B 123 |
| Group using manual toothbrush with 5460 strands | Experimental | Patients will be asked to use a manual toothbrush with 5460 strands for 24 months Receives: Device: Curaprox CS 5460 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (9)
Acceptability
Questionnaire to assess the acceptability of oral hygiene products by patients
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Apr 2025
- Primary completion26 Dec 2026 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental MalpositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nancy
- Responsible party
- Principal investigator, Carrouel Florence, Claude Bernard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851963
- Sponsor's protocol ID
- ORTHO-IOP
- Acronym
- ORTHO-IOP
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Manual and Electric Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances
- ClinicalTrials.gov ID
- NCT05851963
- Acronym / sponsor ID
- ORTHO-IOP / ORTHO-IOP
- Conditions
- Dental Malposition
- Keywords
- toothbrush, oral prophylaxis, adolescents, orthodontic appliances
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Collaborators
- University of Nancy
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 26 Dec 2026 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Group using sonic toothbrush | Experimental | Device: Sonicare Diamond Clean 9000Patients will be asked to use a sonic toothbrush for 24 months |
| Group using hydrosonic toothbrush | Experimental | Device: HydroSonic ProPatients will be asked to use a hydrosonic toothbrush for 24 months |
| Group using manual toothbrush | Placebo comparator | Device: Oral-B 123Patients will be asked to use a manual toothbrush for 24 months |
| Group using manual toothbrush with 5460 strands | Experimental | Device: Curaprox CS 5460Patients will be asked to use a manual toothbrush with 5460 strands for 24 months |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonicare Diamond Clean 9000Brush teeth with the electric toothbrush 1 daily during the orthodontic treatment | Device | Group using sonic toothbrush |
| HydroSonic ProBrush teeth with the electric toothbrush 2 daily during the orthodontic treatment | Device | Group using hydrosonic toothbrush |
| Oral-B 123Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment | Device | Group using manual toothbrush |
| Curaprox CS 5460Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment | Device | Group using manual toothbrush with 5460 strands |
Primary outcome
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
9 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonicare Diamond Clean 9000, HydroSonic Pro and Oral-B 123 in people with Dental Malposition, run by Claude Bernard University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florence Carrouel, PhD (0478785745 ext. +33, florence.carrouel@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.