Anxiety, Pain, and Quality of Life in Orthodontic Treatment

Pain Clinical Trial

Official title:

Comparison of Anxiety, Pain, and Quality of Life in Individuals With Moderate Malocclusion Between Conventional Fixed Treatment and Invisalign: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06133296
• Other study ID #: 2021/02-08
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: November 2023
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was evaluated anxiety, pain, and oral health-related quality of life in individuals treated with conventional fixed appliances (Group A) and clear aligners (Group B) for moderate malocclusion during the initial phase of orthodontic treatment

Description:

Clear aligner treatment is becoming increasingly popular among orthodontic treatment option. With this treatment method, which was introduced the literature at the beginning of the 20th century, approximately four million individuals in 2019 and over twelve million individuals have already been treated today. In addition, the number of commercial companies worldwide producing transparent plaque has reached twenty-seven, indicating that these figures will increase rapidly. Although there are debates about the effectiveness of the treatment, the increase in living standards and the improvement of the quality of life of individuals relative to conventional fixed orthodontic treatment have increased interest in clear aligner treatment.

The World Health Organization has multidimensional definitions of the concepts of "quality of life" and "health," and their common point is that they emphasize the importance of the psychological and social status of individuals in recent years. Quality of life is affected by dentofacial problems caused by malocclusions, as well as the psychosocial state of individuals during orthodontic treatment. Oral health-related quality of life was defined as "the absence of physical and psychological problems in terms of oral health and self-confidence associated with the maxillofacial region," and the importance of self-confidence and psychosocial status that could affect quality of life was emphasized. The presence of pain and anxiety before and at the beginning of orthodontic treatment are among the factors affecting oral health-related quality of life.

Pain is an emotional state frequently encountered by individuals undergoing orthodontic treatment, leading to cooperation problems and even causing them to give up treatment. In studies comparing the pain levels of individuals treated with conventional fixed orthodontic appliances and clear aligners, individuals treated with clear aligners felt less pain in the first few days, but there was no significant difference in pain levels in later periods of treatment.

The importance of malocclusion type and arc length disperancy has been emphasized in studies comparing conventional fixed therapy and clear plating therapy in terms of pain and quality of life. Considering that the concepts of anxiety, pain, and quality of life are interrelated by each other, there are limited studies in which both treatment methods are evaluated in terms of these factors in a particular malocclusion. The current study aims to compare anxiety and pain values observed in the initial phase of orthodontic treatment and oral health-related quality of life among individuals with moderate malocclusion treated with conventional fixed orthodontic appliances and clear aligners. Our null hypothesis (H0) is that there is no difference in anxiety, pain, or oral health-related quality of life between individuals treated with conventional fixed orthodontic appliances and clear aligners.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 28 Years

Eligibility

Inclusion Criteria:

• Individuals who had not received orthodontic treatment before,

• Angle class I malocclusion,

• 4-6 mm arc length disperancy in both dental arches,

• Permanent dentition period,

• Missing or impacted teeth,

• No smoker,

• No alcohol drinker.

Exclusion Criteria:

• Individuals who underwent extraction fixed orthodontic treatment,

• Radiologically observed alveolar bone loss,

• Missing or impacted teeth,

• systemic disease,

• Using of drugs or analgesics.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Malocclusion
• Pain
• Quality of Life

Intervention

Other:
• Conventional fixed treatment
Roth brackets (.018; Gemini Roth System, 3M Unitek, USA) were used for the fixed orthodontic attachment
• Clear aligner treatment
After the clear aligners came from the manufacturer (Align Technology, Santa Clara, CA), the compatibility of the guide aligner with each patient's mouth was checked for attachments

Locations

Country	Name	City	State
Turkey	Van Yuzuncu Yil University	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Alfawal AMH, Burhan AS, Mahmoud G, Ajaj MA, Nawaya FR, Hanafi I. The impact of non-extraction orthodontic treatment on oral health-related quality of life: clear aligners versus fixed appliances-a randomized controlled trial. Eur J Orthod. 2022 Dec 1;44(6):595-602. doi: 10.1093/ejo/cjac012. — View Citation

Flores-Mir C, Brandelli J, Pacheco-Pereira C. Patient satisfaction and quality of life status after 2 treatment modalities: Invisalign and conventional fixed appliances. Am J Orthod Dentofacial Orthop. 2018 Nov;154(5):639-644. doi: 10.1016/j.ajodo.2018.01.013. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS	Visual Analogue Scale (VAS) was used to measure the individuals' pain levels. VAS is a scale that ranges pain severity from 0 to 10. (0= no pain, 10= severe pain)	0 hour, 2 hours, 6 hours, 1st day, 3rd day, 7th day, 14th day, 21st day.
Primary	OHIP-14	The Oral Health Impact Profile-14 (OHIP-14) questionnaires were used to measure quality of life in our study. The OHIP-14 questionnaire consists of seven domains and 14 questions, including those related to functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, and disability. The individuals were asked to answer each question as follows: 0: never, 1: very little, 2: sometimes, 3: quite often, and 4: often. After the results were collected separately for each of the seven subgroups, they were added together to calculate the actual results. High scores obtained on the OHIP-14 questionnaire indicate that quality of life was adversely affected.	Baseline, 10th day, 20th day
Primary	OHRQoL-UK	The Oral Health-Related Quality of Life-United Kingdom (OHRQoL-UK) questionnaires were used to measure quality of life in our study. In the OHRQoL-UK questionnaire, 16 questions were asked in four categories: symptom (two questions), physical condition (five questions), psychological condition (five questions), and social situation (four questions).Answers scored according to the Likert scale were given 1 point for very bad influence, 2 for bad influence, 3 for no effect, 4 for good effect, and 5 for very good effect. The scores ranged from 16 to 80. A high score indicates a good quality of life for oral and dental health, whereas a low score indicates a poor quality of life for oral and dental health.	Baseline, 10th day, 20th day
Secondary	Anxiety	The Spielberger State and Trait Anxiety Inventory (STAI) survey was applied. It includes 40 questions that measure state anxiety (STAI-S, 20) and trait anxiety (STAI-T, 20). The answer categories for the questions varied according to the nature of the problem (e.g., 1: No, 2: slightly, 3: multiple, and 4: always) in the form of a four-point scale.	Before treatment, baseline, 10th day, and 20th day.