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Completed

NCT Number: NCT06133296

Anxiety, Pain, and Quality of Life in Orthodontic Treatment

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

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Key information

Age range

17 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Yuzuncu Yil University

Van, 65080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional fixed treatment

Other

Roth brackets (.018; Gemini Roth System, 3M Unitek, USA) were used for the fixed orthodontic attachment

Clear aligner treatment

Other

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

Primary outcomes

  1. VAS

    Time frame: 0 hour, 2 hours, 6 hours, 1st day, 3rd day, 7th day, 14th day, 21st day.

    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)

  2. OHIP-14

    Time frame: Baseline, 10th day, 20th day

    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.

  3. OHRQoL-UK

    Time frame: Baseline, 10th day, 20th day

    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.

Secondary outcomes

  1. Anxiety

    Time frame: Before treatment, baseline, 10th day, and 20th day.

    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.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 15, 2023
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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