Anxiety, Pain, and Quality of Life in Orthodontic Treatment

NCT06133296 | Completed

• 1 other identifier: 2021/02-08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Malocclusion; Pain; Anxiety; Quality of Life

Keywords

clear aligner; Anxiety; Pain; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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.

• 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

• 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 Outcomes (1)

• Anxiety

  Before treatment, baseline, 10th day, and 20th day.

Study Arms (2)

Group A (Conventional fixed treatment)

ACTIVE COMPARATOR

Roth brackets (.018; Gemini Roth System, 3M Unitek, USA) were used for the fixed orthodontic attachment. Tooth surfaces were etched with 35% gel phosphoric acid for 30 seconds and then washed with water for 15 seconds. A primer was applied to the etching surface with the manufacturer's applicator. After an adhesive was applied to the bases of the brackets, the brackets were placed in their appropriate positions. Afterward, LED was irradiated for 20 seconds and 5 seconds for each surface. For leveling after bonding, .012 nickel titanium archwires (3M Unitek Monrovia, CA, USA) were tied with an elastic ligature.

Other: Conventional fixed treatment

Group B (Clear aligner treatment)

ACTIVE COMPARATOR

Clear aligners were ordered after the recordings were evaluated in the Clincheck program, and the final treatment plan was created. 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. The enamel surfaces on which the attachments will be applied were etching with the same method as in Group A. After an adhesive was condensed into the attachment spaces inside the guide plate, the guide aligner was placed in the correct position in the mouth, and each attachment was applied from the buccal surface with an LED light device for 20 seconds. After the guide plate was removed, the composite residues around the attachments were cleaned, and the first treatment aligner was applied. The individuals were informed that they should use their clear aligner continuously, except during meals, and replace them after 10 days.

Other: Clear aligner treatment

Interventions

Conventional fixed treatment OTHER

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

Group A (Conventional fixed treatment)

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

Group B (Clear aligner treatment)

Eligibility Criteria

• Age: 17 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Individuals who had not received orthodontic treatment before,
• Angle class I malocclusion,
• mm arc length disperancy in both dental arches,
• Permanent dentition period,
• Missing or impacted teeth,
• No smoker,
• No alcohol drinker.

You may not qualify if:

• Individuals who underwent extraction fixed orthodontic treatment,
• Radiologically observed alveolar bone loss,
• Missing or impacted teeth,
• systemic disease,
• Using of drugs or analgesics.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University

Van, 65080, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 35395075 BACKGROUND

• 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.

  PMID: 30384934 BACKGROUND

• Tunca Y, Kaya Y, Tunca M, Keskin S. Comparison of anxiety, pain, and quality of life in individuals with mild or moderate malocclusion between conventional fixed orthodontic treatment versus Invisalign: a randomised clinical trial. BMC Oral Health. 2024 May 17;24(1):576. doi: 10.1186/s12903-024-04335-1.

  PMID: 38760747 DERIVED

MeSH Terms

Conditions

Malocclusion; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Murat Tunca, PhD, DDS

  Yuzuncu Yil University

  PRINCIPAL INVESTIGATOR

• Yesim Kaya, PhD, DDS

  Ankara Yildirim Beyazıt University

  STUDY CHAIR

• Yasemin Tunca, PhD, DDS

  Yuzuncu Yil University

  STUDY CHAIR

• Siddik Keskin, PhD, DDS

  Yuzuncu Yil University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, DDS, Assistant Professor

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 15, 2023
• Study Start: March 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)