Actively Recruiting
Effect of Health Diary on Self-management in Adolescent Patients With Orthodontic Fixed Appliance: A Randomized Controlled Trial
Led by Wei XIA, PhD · Updated on 2024-07-25
140
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of a health diary on adolescents wearing fixed orthodontic appliances to help improve their oral hygiene, self-management skills, oral health-related quality of life, self-efficacy, intention, appliance breakages, and timely follow-up visits. This randomized clinical trial compares traditional health education alone to a health diary combined with traditional education. The study is led by Wei XIA, PhD, and focuses on adolescent patients aged 12 to 18 undergoing their first orthodontic treatment. Participants are randomly assigned to one of two groups. The control group receives routine oral health education and instructions during their orthodontic visits. The intervention group receives the same traditional education plus a health diary designed to help plan and track their self-management behaviors during treatment. The diary is based on the health action process approach and supports adolescents in managing their fixed orthodontic appliances. During the 24-week study period, researchers assess changes in plaque index and bleeding index as primary outcomes. Secondary outcomes include improvements in self-management ability, self-efficacy, oral health-related quality of life, number of appliance damages, and adherence to follow-up visits. Participants complete questionnaires and attend regular visits to monitor their oral hygiene and treatment progress.
CONDITIONS
Brief Title
Effect of Health Diary on Self-management in Adolescent Patients With Fixed Orthodontic Appliance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with malocclusion eligible for fixed appliance orthodontic treatment
- Age between 12 and 18 years
- Receiving orthodontic treatment for the first time
- Alert with no cognitive or psychiatric impairment
- Able to read, understand, and complete questionnaires in Chinese with good communication skills
You will not qualify if you...
- Diagnosed jaw deformity caused by trauma, tumor, cleft lip, or palate
- Treated with orthodontic-orthognathic surgery
- Currently participating in other oral health-related intervention studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants receive either traditional health education or a health diary program to support self-management behaviors during fixed orthodontic treatment.
Regular follow-up visits during the 24-week intervention
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
W
Wei Xia, PhD
J
Jie Chen, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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