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

NCT ID: NCT04444154

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-29
• Study Completion Date: 2025-01-29

Brief 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. 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.

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).

Conditions

Orthodontic Appliance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control group

oral hygiene advice given orally

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: BEHAVIORAL

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

Group with active participation

oral hygiene advice given orally and demonstration of brushing methods in the sink with active participation

Group Type: ACTIVE_COMPARATOR

Group with active participation

Intervention Type: BEHAVIORAL

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 quizz

oral 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).

Group Type: EXPERIMENTAL

Group with video and quizz

Intervention Type: BEHAVIORAL

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).

Interventions

Control group

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

Intervention Type: BEHAVIORAL

Group with active participation

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.

Intervention Type: BEHAVIORAL

Group with video and quizz

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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;
• 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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damien BREZULIER, Dr

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

CHU de RENNES

Rennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Damien BREZULIER, Dr

Role: CONTACT

damien.brezulier@chu-rennes.fr

02 99 28 24 00

Facility Contacts

Damien BREZULIER, Dr

Role: primary

damien.brezulier@chu-rennes.fr

02 99 28 24 00

References

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.

Reference Type: DERIVED

PMID: 33588930 (View on PubMed)

Other Identifiers

35RC20_8945_MAHO

Identifier Type: -

Identifier Source: org_study_id