Oral HygieneNCT06461611
Effect of Health Diary on Self-management in Adolescent Patients With Fixed Orthodontic Appliance
A study testing Health Diary Program and Traditional Health Education in people with Oral Hygiene and Self-Management, run by Wei XIA, PhD at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Oral Hygiene, Self-Management
- What is being tested?
- Health Diary Program and Traditional Health Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University
Guangzhou, Guangdong, 510080
Wei Xia, PhD, +8618823359471, xiaw23@mail.sysu.edu.cn
Jie Chen, Master, 13640838051, chenjttxs@163.com
About this study
Official title: Effect of Health Diary on Self-management in Adolescent Patients With Orthodontic Fixed Appliance: A Randomized Controlled Trial
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
- Being tested
- Health Diary Program, Traditional Health Education
- Keywords
- Malocclusion, Fixed Orthodontic Treatment, Adolescent, Self-Management, Self-Efficacy, Health Diary, Oral Health-Related Quality of Life, Oral Hygiene
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Diary ProgramBehavioural
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.
Traditional Health EducationBehavioural
Traditional health education is that the nurse orally teaches the patient about fixed orthodontic knowledge, and the patient obtains a paper information.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Health Diary Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline plaque index at 24-weeks follow-up.
Secondary outcomes (5)
Self-Management Ability
The self-management Ability scale for Adolescent Patients with fixed orthodontics was used for evaluation. The higher the score of the scale, the higher the self-management ability.
Measured: Change from baseline plaque index at 24-weeks follow-up.
Self Efficacy
Self-efficacy in this study refers to oral health care self-efficacy, as assessed by the Oral Health Care Self-efficacy Scale (SEOH-C), with higher scale scores indicating greater self-efficacy.
Measured: Change from baseline plaque index at 24-weeks follow-up.
Oral Health Related Quality of Life
OHRQoL was assessed using the Oral Health Impact Profile 14 (OHIP-14), with higher score indicating lower oral health-related quality of life.
Measured: Change from baseline plaque index at 24-weeks follow-up.
The number of appliance damage in each follow-up period
The compliance of diet management was indirectly evaluated by monitoring the number of appliance damage. The number of appliance damage between the date of the current visit and the expected date of the next visit was recorded as follows: number of appliance damage = number of brackets lost + number of buccal canals lost + number of archwires broken + number of archwires slipped out of the bracket.
Measured: The number of appliance damage in each follow-up period change over 24 weeks during intervention from baseline.
On-time follow-up visits
In this study, on-time follow-up was defined as the patients attending the follow-up date according to the doctor's advice, and the treatment content on the day of the follow-up visit was adjustment of appliance force, etc. The following orthodontic emergencies were excluded: the treatment only involved the patients who did not meet the doctor's advice for the follow-up due to pain and discomfort caused by bracket loss, buccal canal loss, arch wire fracture, or arch wire slipping out of the bracket groove, and the routine orthodontic follow-up was not involved during the treatment. The on-time return visit was judged according to the interval days between the date of the patient's doctor's advice and the actual date of return visit, and the absolute value of the date of the doctor's advice minus the actual date of return visit was recorded. A difference of "0" was marked as "very punctual"; 0 to 14 was scored as "on time" and more than 14 as "not on time".
Measured: On-time follow-up visits change over 24 weeks during intervention from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jun 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei XIA, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei XIA, PhD, Sun Yat-sen University
- Investigators
- Wei Xia, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461611
- Sponsor's protocol ID
- CJ-KQEC-2024-48-01
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Health Diary on Self-management in Adolescent Patients With Orthodontic Fixed Appliance: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06461611
- Acronym / sponsor ID
- CJ-KQEC-2024-48-01
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Wei XIA, PhDUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Behavioral: Traditional Health EducationPatients 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. |
| Intervention Group | Experimental | Behavioral: Health Diary ProgramPatients 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Diary ProgramThe 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. | Behavioural | Intervention Group |
| Traditional Health EducationTraditional health education is that the nurse orally teaches the patient about fixed orthodontic knowledge, and the patient obtains a paper information. | Behavioural | Control Group |
Primary outcome
Plaque Index
Time frame: Change from baseline plaque index at 24-weeks follow-up.
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.
Bleeding Index
Time frame: Change from baseline plaque index at 24-weeks follow-up.
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.
5 secondary outcomes
Self-Management Ability
Time frame: Change from baseline plaque index at 24-weeks follow-up.
Self Efficacy
Time frame: Change from baseline plaque index at 24-weeks follow-up.
Oral Health Related Quality of Life
Time frame: Change from baseline plaque index at 24-weeks follow-up.
The number of appliance damage in each follow-up period
Time frame: The number of appliance damage in each follow-up period change over 24 weeks during intervention from baseline.
On-time follow-up visits
Time frame: On-time follow-up visits change over 24 weeks during intervention from baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Xia, PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Diary Program and Traditional Health Education in people with Oral Hygiene and Self-Management, run by Wei XIA, PhD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Xia, PhD (+8618823359471, xiaw23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index (time frame: Change from baseline plaque index at 24-weeks follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.