Effect of Health Diary on Self-management in Adolescent Patients With Fixed Orthodontic Appliance

Wei XIA, PhD

Status: Enrolling

Conditions: Oral Hygiene; Self-Management

Treatments: Behavioral: Traditional Health Education; Behavioral: Health Diary Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06461611

CJ-KQEC-2024-48-01

Details and patient eligibility

About

This study aims to use two-arm randomized clinical trials to evaluate the effectiveness of the health diary in helping adolescents wearing fixed orthodontic appliances improve their oral hygiene status, self-management skills, oral health-related quality of life, self-efficacy, intention，number of breakages, and on-time and return visit status.

Enrollment: 140 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with malocclusion eligible for fixed appliance orthodontic treatment;
• The age of patients ranged from 12 to 18 years;
• The patients received orthodontic treatment for the first time;
• The patient was alert and had no cognitive or psychiatric impairment;
• The patient was able to read and fill out the questionnaires, and had good listening, speaking and understanding skills in Chinese.

Exclusion criteria

• The patient's disease was diagnosed as jaw deformity associated with other diseases. Malocclusion secondary to trauma, tumor, cleft lip and palate;
• Patients treated with orthodontic-orthognathic surgery;
• The patient currently participating in other oral related intervention studies.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

140 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

Patients in the control group will receive traditional health education, which consist of routine oral health education and oral health instructions during their visits for orthodontic treatment.

Treatment:

Behavioral: Traditional Health Education

Intervention Group

Experimental group

Description:

Patients in the intervention group will receive a health diary to plan and clock for their fixed orthodontic self-management behaviors in addition to the traditional health education.

Treatment:

Behavioral: Health Diary Program