Anxiety, Pain, and Quality of Life in Orthodontic Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Side Effects of Different Treatment Methods

NCT06709287

Root Resorption Pain Chewing Function

COMPLETED

Evaluation of Removable Appliances and Clear Aligners in Early Orthodontic Treatments During the Mixed Dentition Period

NCT07331090

Malocclusion Crossbite

COMPLETED

Pain, Anxiety, and Impacts on Oral Health-related Quality of Life for Patients With Orthodontic Treatment

NCT06150911

Pain Anxiety Oral Health Related Quality of Life

UNKNOWN

Comparison of Oral Health Related Quality of Life Changes Between Clear Aligners and Vestibular Fixed Appliances

NCT04866238

Teeth Crowding

COMPLETED NA

Oral Health-Related Quality of Life Between Two Different Types of Orthodontic Appliances

NCT06401382

Crowding of Anterior Mandibular Teeth

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malocclusion Pain Anxiety Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A (Conventional fixed treatment)

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.

Group Type ACTIVE_COMPARATOR

Conventional fixed treatment

Intervention Type OTHER

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

Group B (Clear aligner treatment)

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.

Group Type ACTIVE_COMPARATOR

Clear aligner treatment

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Conventional fixed treatment

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

17 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes