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

NCT ID: NCT06461611

Last Updated: 2024-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Hygiene Self-Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators
A qualified examiner blinded to individual subject treatment assignments performed the oral hygiene status index (SBI and PLI)on subjects.

Study Groups

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Control Group

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.

Group Type PLACEBO_COMPARATOR

Traditional Health Education

Intervention Type BEHAVIORAL

Traditional health education is that the nurse orally teaches the patient about fixed orthodontic knowledge, and the patient obtains a paper information.

Intervention Group

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.

Group Type EXPERIMENTAL

Health Diary Program

Intervention Type BEHAVIORAL

The health diary is constructed based on the theory of health action process approach, which is used to plan and clock for self-management behaviors of adolescent patients during fixed orthodontic treatment.

Interventions

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Health Diary Program

The health diary is constructed based on the theory of health action process approach, which is used to plan and clock for self-management behaviors of adolescent patients during fixed orthodontic treatment.

Intervention Type BEHAVIORAL

Traditional Health Education

Traditional health education is that the nurse orally teaches the patient about fixed orthodontic knowledge, and the patient obtains a paper information.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wei XIA, PhD

OTHER

Sponsor Role lead

Responsible Party

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Wei XIA, PhD

Association Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wei Xia, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Xia, PhD

Role: CONTACT

+8618823359471

Jie Chen, Master

Role: CONTACT

+8613640838051

Facility Contacts

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Wei Xia, PhD

Role: primary

+8618823359471

Jie Chen, Master

Role: backup

13640838051

Other Identifiers

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CJ-KQEC-2024-48-01

Identifier Type: -

Identifier Source: org_study_id

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