Clinical trial NCT06150911: Pain, Anxiety, and Impacts on Oral Health-related Quality of Life for Patients With Orthodontic Treatment
Official title: A Study of Pain, Anxiety, and Impacts on Oral Health-related Quality of Life(OHRQoL) for Patients Before, During and After Orthodontic Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain
Anxiety
Oral Health Related Quality of Life
Keywords: Visual Analogue Scale(VAS) pain scale
Generalized Anxiety Disorder 7-item (GAD-7) scale
Oral health impact profile-14(OHIP-14) scale
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: study population are orthodontic patients which are recruited from orthodontic department ,Kaohsiung medical university and local dental clinics

Brief summary: The goal of this observational study is to learn about pain, anxiety, and impacts on oral health-related quality of life(OHRQoL) for patients before, during and after orthodontic treatment. The recruited participants with good health are from Kaohsiung medical university and local dental clinics .

The main questions it aims to answer are:

1. The differences of pain, anxiety, and impacts on oral health-related quality of life(OHRQoL) for patients before, during and after orthodontic treatment.
2. The correlation of pain, anxiety and oral health-related quality of life in our participant
3. The differences of seven domain in OHIP-14 scale in our participants The participants are asked to complete a self-administered in different time point.

Detailed description: Orthodontic treatment is a common dental procedure aimed at improving teeth and bite alignment issues. Patients may experience various challenges before, during, and after orthodontic treatment, including pain, anxiety, and the impact on oral health-related quality of life. Here are some aspects to consider in researching these areas:

Pain: Orthodontic treatment typically causes a certain level of discomfort and pain. Research can focus on assessing changes in the intensity and frequency of pain experienced by patients before, during, and after treatment. Pain can be evaluated using visual analog scales or numerical rating scales, and the duration and relief of pain should be tracked.

Anxiety: Orthodontic treatment may induce anxiety and stress in some patients. Studies can assess anxiety levels at different stages of treatment through surveys or psychological measurement tools like anxiety assessment scales. Additionally, observing patients' behavior and emotional responses during treatment can provide insights into their anxiety levels.

Oral Health-Related Quality of Life: The success of orthodontic treatment is not solely determined by tooth movement but also relates to patients' oral health-related quality of life indicators. These indicators may include oral hygiene habits, dietary changes, and satisfaction with the treatment process. Questionnaires, oral examinations, and oral health-related quality of life assessment tools can be used to evaluate these aspects.

Researching these areas can help us gain a better understanding of patients' experiences and needs during orthodontic treatment. This, in turn, can aid in improving treatment methods and providing better patient care. Furthermore, research findings can be used to offer education and guidance to patients before, during, and after treatment to alleviate their pain and anxiety and promote oral health maintenance.

In summary, orthodontic treatment can significantly benefit patients in terms of addressing bite alignment issues and improving their psychological, physiological, and social interactions. However, in Taiwan, there is a lack of systematic research on the changes in pain, anxiety, and oral health-related quality of life indicators experienced by patients before, during, and after orthodontic treatment. Therefore, this study aims to investigate these issues through structured questionnaires among patients undergoing orthodontic treatment.

Eligibility criteria: Inclusion Criteria:

* Orthodontic patient with clinical diagnosis malocclusion
* Age from 18 to 60 years old

Exclusion Criteria:

* Systemic and psychological disease
* Craniofacial deformity
* Received orthodontic treatment beforehand

Primary outcomes:
measure: Visual Analogue Scale(VAS) pain scale
timeFrame: 2 years
measure: Generalized Anxiety Disorder 7-item (GAD-7) scale
timeFrame: 2 years
measure: Oral health impact profile(OHIP)-14 scale; self-administered questionnaire
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung medical university
Study officials:
affiliation: Kaohsiung Medical University
name: Yu-Chuan Tseng, PHD
role: STUDY_CHAIR
References: