Clinical trial NCT04444154: Comparison of the Effectiveness of Three Teaching Methods in Oral Hygiene in Adolescent Orthodontic Patients
Official title: Comparison of the Effectiveness of 3 Teaching Methods in Oral Hygiene in Adolescent Orthodontic Patients: Prospective Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Appliance
Keywords: orthodontic appliance
oral hygiene
modified orthodontic plaque index
Loë and Silness
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 90
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, monocentric, controlled, randomized study
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Compare the effectiveness of 3 methods of teaching oral hygiene in terms of controlling biofilm formation: MOP (Modified Orthodnotic Plaque Index) classification
timeFrame: 6 months of intervention
Secondary outcomes:
measure: 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
timeFrame: 6 months after bonding the device.
measure: Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index
timeFrame: J0 (during the installation of the device)
measure: Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale
timeFrame: J0 (during the installation of the device)
measure: Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index
timeFrame: at 1½ months after installation of the device
measure: Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale
timeFrame: at 1½ months after installation of the device
measure: Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index
timeFrame: at 3 months after installation of the device
measure: Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale
timeFrame: at 3 months after installation of the device
measure: Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index
timeFrame: at 4½ months after installation of the device
measure: Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale
timeFrame: at 4½ months after installation of the device
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de RENNES
Study officials:
affiliation: Rennes University Hospital
name: Damien BREZULIER, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.