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

NCT06461611 | Recruiting DMC

• 1 other identifier: CJ-KQEC-2024-48-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Hygiene; Self-Management

Keywords

Malocclusion; Fixed Orthodontic Treatment; Adolescent; Self-Management; Self-Efficacy; Health Diary; Oral Health-Related Quality of Life; Oral Hygiene

Outcome Measures

Primary Outcomes (2)

• Plaque Index

  Ramfjord index teeth (16, 21, 24/25, 36, 41, 44/45) were selected. After staining with plaque stain, the plaque area of mesial, middle buccal, distal buccal and lingual surface of each tooth was examined, and the average value of the four dental surfaces was recorded. Finally, the PLI score was calculated by adding the index teeth and dividing by the number of teeth examined.

  Change from baseline plaque index at 24-weeks follow-up.

• Bleeding Index

  It is a combination of visual examination and probing. The probe was inserted into the gingival sulcus for 1 second and then removed. After 30 seconds, the gingival bleeding and the degree of bleeding were observed. Ramfjord index teeth were selected, namely 16, 21, 24/25, 41, 44/45.The detection sites of each index tooth included 6 sites in the mesial, distal and central of the buccal and lingual surface. The sum of the scores of the examined teeth and then divided by the number of examined teeth were used to determine the SBI score of the patient.

  Change from baseline plaque index at 24-weeks follow-up.

Secondary Outcomes (5)

• Self-Management Ability

  Change from baseline plaque index at 24-weeks follow-up.

• Self Efficacy

  Change from baseline plaque index at 24-weeks follow-up.

• Oral Health Related Quality of Life

  Change from baseline plaque index at 24-weeks follow-up.

• The number of appliance damage in each follow-up period

  The number of appliance damage in each follow-up period change over 24 weeks during intervention from baseline.

• On-time follow-up visits

  On-time follow-up visits change over 24 weeks during intervention from baseline.

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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.

Behavioral: Traditional Health Education

Intervention Group

EXPERIMENTAL

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.

Behavioral: Health Diary Program

Interventions

Health Diary Program 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.

Intervention Group

Traditional Health Education BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wei XIA, PhD: lead

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Wei Xia, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Xia, PhD

CONTACT

+8618823359471; xiaw23@mail.sysu.edu.cn

Jie Chen, Master

CONTACT

+8613640838051; chenjttxs@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: A qualified examiner blinded to individual subject treatment assignments performed the oral hygiene status index （SBI and PLI）on subjects.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Association Professor

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: June 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: July 31, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)