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Orthodontic ApplianceMAHONCT04444154

Comparison of the Effectiveness of Three Teaching Methods in Oral Hygiene in Adolescent Orthodontic Patients

A study testing Group with active participation and Group with video and quizz in people with Orthodontic Appliance, run by Rennes University Hospital at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Orthodontic appliances have been shown to interfere with oral hygiene maneuvers by providing many additional sites for formation and retention of biofilm. Its accumulation is responsible for undesirable effects such as decays and periodontal pathologies. These lower the benefit / risk ratio of orthodontic treatments. Read more about this study

Who is it for?
Ages 11 to 17 years
Conditions the study is for
Orthodontic Appliance
What is being tested?
Group with active participation and Group with video and quizz
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteFrance
Study dates
29 Jan 2022to 21 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

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 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patient aged 11 to 17 * years;
  • Patient with stable adolescent teeth, young adult or adult teeth;
  • Requiring a fixed orthodontic treatment without extraction (other than wisdom teeth) at least to the maxillary arch;
  • Affiliated, himself or through his parents to a social security scheme;
  • Having received information on the protocol and having given free, informed and written consent.
  • Whose holders of parental authority have received information on the protocol and have given free, informed and written consent.
  • Aged under 18 at the end of the 6 months of participation

Who cannot join

  • Patient with periodontal disease or progressive carious lesions;
  • Patient with a prosthetic crown or composite restoration on the central and / or lateral maxillary incisor;
  • Patient with systemic disease, major syndrome or cleft palate;
  • Patient with an abnormal dental structure (eg fluorosis, MIH, imperfect amelogenesis, etc.);
  • Patients taking long-term medication influencing periodontal health (corticosteroids, anti-epileptics, etc.);
  • Patient with a physical or mental handicap preventing him from carrying out oral hygiene maneuvers independently;
Show all 12Show fewer
  • Patient refusing to use the products and instruments prescribed for the study;
  • Patients with dental agenesis;
  • Patients with poor command of the French language
  • Patient deprived of liberty by judicial or administrative decision or subject to a legal protection measure;
  • Pregnant patient;
  • Smoking patient.

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU de RENNES

    Rennes

Other trials in France

About this study

Official title: Comparison of the Effectiveness of 3 Teaching Methods in Oral Hygiene in Adolescent Orthodontic Patients: Prospective Randomized Controlled Clinical Study

Orthodontic appliances have been shown to interfere with oral hygiene maneuvers by providing many additional sites for formation and retention of biofilm.

Its accumulation is responsible for undesirable effects such as decays and periodontal pathologies. These lower the benefit / risk ratio of orthodontic treatments. In addition, their management is not negligible at the macroeconomic level.

As such, it is more than necessary for the orthodontist to teach oral hygiene methods adapted to each of his patients fitted to limit the risk of appearance of biofilm.

Read the detailed description

Patients applying for orthodontic treatment with braces in the orthodontic unit of the Rennes dental center will be offered to participate in the study. For each patient, the inclusion and non-inclusion criteria will be checked, and consent and a document explaining the course of the study will be delivered to them personally. The duration of the study will be 6 months for each of them. Each will be randomized to one of three study groups. Throughout the study, patients in groups 1 and 2 will have to make 5 appointments. Group 3 patients must honor 6 appointments.

Patients in group 1 (control group) will receive oral hygiene advice given orally in the chair during the bonding appointment and at each check-up appointment. Patients in group 2 will receive these same oral advice, associated with a demonstration of brushing methods in the sink with active participation (use of plate developer and then the Oral B electric toothbrush with special orthodontic head) during the bonding appointment as well than at each check-up appointment. Patients in group 3 will receive the same treatment as those in group 1 but will have an additional appointment between the device bonding appointment and the first check-up. This is a 15-minute session dedicated to teaching oral hygiene. This session will include watching of an educational video followed by a quiz, as well as the application of the methods taught in the sink (using plate developer and the Oral B electric toothbrush with special orthodontic head).

At the end of the appliance bonding appointment (first appointment) each patient (from each group) will leave with a hygiene kit including an electric toothbrush with two orthodontic heads, an Oral B toothpaste, from orthodontic wax and the analgesic prescription conventionally performed when installing a device.

The plaque index readings, i.e. the taking of 3 macrophotographic shots (with reflex camera, allowing the MOP plaque index to be assessed in a second step), and the clinical index of gingival inflammation will be performed at each appointment (except during the dedicated session of group 3) by an examiner who will be blind from the group belonging to each patient.

Exception made for the day of bonding, during which the plate index reading will be made just before the placement of the multi fasteners via the Loë and Silness plate index (which is an index adapted to patients not fitted).

Being tested
Control group, Group with active participation, Group with video and quizz
Keywords
orthodontic appliance, oral hygiene, modified orthodontic plaque index, Loë and Silness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control groupBehavioural

    oral hygiene advice given orally in the chair during the bonding appointment and at each check-up appointment.

  • Group with active participationBehavioural

    oral hygiene advice given orally in the chair during the bonding appointment and at each check-up appointment with a demonstration of brushing methods in the sink with active participation (use of plate developer and then the Oral B electric toothbrush with special orthodontic head) during the bonding appointment as well than at each check-up appointment.

  • Group with video and quizzBehavioural

    oral hygiene advice given orally in the chair during the bonding appointment and at each check-up appointment with have an additional appointment between the device bonding appointment and the first check-up. This is a 15-minute session dedicated to teaching oral hygiene. This session will include watching of an educational video followed by a quiz, as well as the application of the methods taught in the sink (using plate developer and the Oral B electric toothbrush with special orthodontic head).

Study groups in NCT04444154
Study groupRoleWhat they receive
Control groupActive comparatororal hygiene advice given orally
Receives: Behavioral: Control group
Group with active participationActive comparatororal hygiene advice given orally and demonstration of brushing methods in the sink with active participation
Receives: Behavioral: Group with active participation
Group with video and quizzExperimentaloral hygiene advice given orally and an additional appointment between the device bonding appointment and the first check-up. This is a 15-minute session dedicated to teaching oral hygiene. This session will include watching of an educational video followed by a quiz, as well as the application of the methods taught in the sink (using plate developer and the Oral B electric toothbrush with special orthodontic head).
Receives: Behavioral: Group with video and quizz

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare the effectiveness of 3 methods of teaching oral hygiene in terms of controlling biofilm formation: MOP (Modified Orthodnotic Plaque Index) classification

    The average plaque index at six months after inclusion according to the MOP (Modified Orthodnotic Plaque Index) classification. It is evaluated on macro photography in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit.

    Measured: 6 months of intervention

Secondary outcomes (9)
  1. Compare the effectiveness of three teaching methods in oral hygiene for the control of gum inflammation: gingival index at six months after inclusion according to the Loë and Silness scale

    The mean gingival index at six months after inclusion according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit.

    Measured: 6 months after bonding the device.

  2. Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index

    The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The first is the MOP classification plate index. It is evaluated on macrophotographs in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit.

    Measured: J0 (during the installation of the device)

  3. Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale

    The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The second is the gingival index according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit.

    Measured: J0 (during the installation of the device)

  4. Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index

    The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The first is the MOP classification plate index. It is evaluated on macrophotographs in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit.

    Measured: at 1½ months after installation of the device

  5. Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale

    The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The second is the gingival index according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit.

    Measured: at 1½ months after installation of the device

  6. Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index

    The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The first is the MOP classification plate index. It is evaluated on macrophotographs in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit.

    Measured: at 3 months after installation of the device

  7. Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale

    The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The second is the gingival index according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit.

    Measured: at 3 months after installation of the device

  8. Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index

    The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The first is the MOP classification plate index. It is evaluated on macrophotographs in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit.

    Measured: at 4½ months after installation of the device

  9. Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale

    The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The second is the gingival index according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit.

    Measured: at 4½ months after installation of the device

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2020
  2. Study start29 Jan 2022
  3. Primary completion21 Feb 2025
  4. Study completion21 Feb 2025

Resources

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
prospective, monocentric, controlled, randomized study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04444154
Sponsor's protocol ID
35RC20_8945_MAHO
Acronym
MAHO
Status last verified
Jun 2026
First submitted
12 May 2020
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Le Fouler A, Jeanne S, Sorel O, Brezulier D. How effective are three methods of teaching oral hygiene for adolescents undergoing orthodontic treatment? The MAHO protocol: an RCT comparing visual, auditory and kinesthetic methods. Trials. 2021 Feb 15;22(1):144. doi: 10.1186/s13063-021-05093-z.

    PubMed 33588930

Questions about this trial

What is this clinical trial studying?

A study testing Group with active participation and Group with video and quizz in people with Orthodontic Appliance, run by Rennes University Hospital 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 16 Jun 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the effectiveness of 3 methods of teaching oral hygiene in terms of controlling biofilm formation: MOP (Modified Orthodnotic Plaque Index) classification (time frame: 6 months of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04444154, which also lists 1 linked publication.

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 16 Jun 2026.

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