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

NCT04444154 | Unknown

• 1 other identifier: 35RC20_8945_MAHO
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthodontic Appliance

Keywords

orthodontic appliance; oral hygiene; modified orthodontic plaque index; Loë and Silness

Outcome Measures

Primary Outcomes (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.

  6 months of intervention

Secondary Outcomes (9)

• 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

  6 months after bonding the device.

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

  J0 (during the installation of the device)

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

  J0 (during the installation of the device)

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

  at 1½ months after installation of the device

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

  at 1½ months after installation of the device

Study Arms (3)

Control group

ACTIVE COMPARATOR

oral hygiene advice given orally

Behavioral: Control group

Group with active participation

ACTIVE COMPARATOR

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

Behavioral: Group with active participation

Group with video and quizz

EXPERIMENTAL

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).

Behavioral: Group with video and quizz

Interventions

Control group BEHAVIORAL

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

Control group

Group with active participation 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 active participation

Group with video and quizz 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).

Group with video and quizz

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU de RENNES

Rennes, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 33588930 DERIVED

MeSH Terms

Interventions

Control Groups; Population Groups; Videotape Recording

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Demography; Population Characteristics; Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Damien BREZULIER, Dr

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damien BREZULIER, Dr

CONTACT

02 99 28 24 00; damien.brezulier@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, monocentric, controlled, randomized study

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: June 23, 2020
• Study Start: January 29, 2022
• Primary Completion: January 29, 2025
• Study Completion: January 29, 2025
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)