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

NCT ID: NCT07331090

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2025-05-15

Brief Summary

This study aims to compare two different orthodontic treatment modalities-clear aligners and removable appliances-in children aged 6 to 12 years during the mixed dentition period. The primary focus of the research is to evaluate treatment-related changes in oral hygiene status, oral health-related quality of life, pain and anxiety levels, and speech function. By assessing multiple dimensions associated with early orthodontic intervention, the study seeks to provide a comprehensive understanding of how different appliance types influence clinical, functional, and psychosocial outcomes in pediatric patients.

Detailed Description

This study aims to compare two different orthodontic treatment modalities-clear aligners and removable appliances-in children aged 6 to 12 years during the mixed dentition period. The primary focus of the research is to evaluate treatment-related changes in oral hygiene status, oral health-related quality of life, pain and anxiety levels, and speech function. By assessing multiple dimensions associated with early orthodontic intervention, the study seeks to provide a comprehensive understanding of how different appliance types influence clinical, functional, and psychosocial outcomes in pediatric patients.

Detailed Description The mixed dentition period, occurring approximately between the ages of 6 and 12, represents a transitional developmental stage during which primary and permanent teeth coexist. In this phase, early diagnosis and treatment of orthodontic anomalies are particularly important to support functional, aesthetic, and psychosocial development and to minimize the need for more complex treatment in later stages.

Removable orthodontic appliances have traditionally been used to guide dental arch development, correct minor malocclusions, and eliminate harmful oral habits. Advances in digital technology have introduced clear aligners as an alternative treatment option that offers aesthetic and removable features. Despite their differences in design and material characteristics, both approaches are commonly used during early orthodontic treatment planning.

Orthodontic appliances may influence various aspects of oral function, including oral hygiene maintenance, periodontal health, caries risk, pain perception, anxiety levels, and speech performance. In growing children, treatment experiences may additionally shape cooperation, adaptation, and overall quality of life. Therefore, evaluating orthodontic interventions during the mixed dentition period requires consideration of not only mechanical efficiency but also broader functional and psychosocial parameters.

Appliance-related changes in intraoral volume and tongue movement can alter speech production, potentially affecting articulatory patterns and acoustic characteristics. Contemporary acoustic analysis methods, such as the use of specialized speech software, allow the objective measurement of frequency- and time-based acoustic parameters and provide complementary information to clinical observations.

This prospective study was designed to investigate how clear aligners and removable appliances influence oral hygiene status, pain and anxiety perception, oral health-related quality of life, and speech performance in children. Through standardized clinical assessments, validated questionnaires, and acoustic analysis, the study aims to generate multidimensional data that may guide clinical decision-making in early orthodontic treatment planning.

Conditions

Malocclusion; Crossbite

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients treated with clear aligners

Patients aged between 6 and 12 years who required early orthodontic treatment and started clear aligner therapy were included in the study.

No interventions assigned to this group

Patients treated with removable orthodontic appliances

Patients aged between 6 and 12 years who required early orthodontic treatment and started removable orthodontic appliance therapy were included in the study.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Children aged between 6 and 12 years who applied to the Clinics of the Departments of Pedodontics and Orthodontics at Marmara University Faculty of Dentistry were included in the study.

• Patients were required to present with anterior cross-bite type malocclusion.
• Participants had to be cooperative, native Turkish speakers, and have no systemic disease, syndrome, craniofacial anomaly, or known allergy.
• Individuals with no apparent oro-facial anomaly, no hearing or speech impairment, and no reading or language difficulties were included.
• Based on clinical and radiographic evaluations, only patients whose malocclusions were determined to be dental in origin (not skeletal) were selected.
• Patients who did not require maxillary (palatal) expansion were also included in the study.

Exclusion Criteria

• The study excluded patients who had severe periodontal disease, a history of systemic illness, a known allergy to any of the materials used in the study, poor oral hygiene, insufficient cooperation, or who did not agree to attend regular follow-up appointments during the study period.

Additionally, individuals with craniofacial anomalies or skeletal-origin malocclusions were not included. Participants with hearing impairments, non-native Turkish speakers, or those with any disease or history of surgery that could affect voice or speech quality were also excluded from the study.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: collaborator

Neslihan Atmaca

OTHER

Sponsor Role: lead

Responsible Party

Neslihan Atmaca

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Neslihan Atmaca, Doctor of Dental Surgery

Role: PRINCIPAL_INVESTIGATOR

Marmara Universty Faculty of Dentistry

Locations

Marmara Universty School of Dentistry

Istanbul, Maltepe, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MUPEDDENTNSL

Identifier Type: -

Identifier Source: org_study_id