Using a health diary to improve self-management in adolescents with braces
Effect of Health Diary on Self-management in Adolescent Patients With Orthodontic Fixed Appliance: A Randomized Controlled Trial
This study tests whether using a health diary can help teenagers with braces take better care of their teeth and improve their overall experience during treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06461611 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a health diary program compared to traditional health education for adolescents aged 12 to 18 who are undergoing fixed orthodontic treatment. The study aims to enhance oral hygiene, self-management skills, and overall oral health-related quality of life among participants. By utilizing a two-arm randomized design, the trial will assess various outcomes including self-efficacy, intention, and the frequency of orthodontic appliance breakages. Participants will be required to complete questionnaires to track their progress and experiences throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to 18 with malocclusion who are starting fixed orthodontic treatment for the first time.
Not a fit: Patients with jaw deformities related to other diseases or those currently involved in other oral intervention studies may not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could significantly improve oral hygiene and self-management skills in adolescents undergoing orthodontic treatment.
How similar studies have performed: While the specific approach of using a health diary is novel, similar studies have shown that structured self-management programs can improve health outcomes in adolescents.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Wei Xia, PhD — Sun Yat-sen University
- Study coordinator: Wei Xia, PhD
- Email: xiaw23@mail.sysu.edu.cn
- Phone: +8618823359471
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.