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

NCT07331090 | Completed

• 1 other identifier: MUPEDDENTNSL
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion; Crossbite

Keywords

Removable Orthodontic Appliances; Clear Aligners; Oral Health-Related Quality of Life; Phonation; Anxiety; Visual Analog Scale (VAS)

Outcome Measures

Primary Outcomes (1)

• Formant frequencies (F1-F4) during speech production

  Evaluation of phonation changes during early orthodontic treatment by analysing the first four formant frequencies (F1-F4) obtained from standardized speech recordings. Recordings were collected immediately before appliance placement and on days 1, 3, 7, and 14 after appliance insertion. Words selected from a standardized articulation test were read aloud by the participants, and acoustic data were analysed using Praat software to assess treatment-related variations in vowel resonance patterns. Units: Hertz (Hz) Higher values indicate: Changes in vowel resonance characteristics potentially related to treatment-related alterations in oral cavity configuration.

  At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.

Secondary Outcomes (9)

• Voice Onset Time (VOT)

  At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.

• Spectral Centre of Gravity (CoG)

  At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.

• Spectral skewness

  At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.

• Spectral kurtosis

  At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.

• Plaque Index (PI; Silness & Löe)

  At baseline (before treatment) and 14th days of treatment.

Other Outcomes (2)

• Baseline oral health-related quality of life (COHIP-SF 19)

  At baseline (before treatment)

• Dental caries experience (DMFT/dft)

  At baseline (before treatment)

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of systemically healthy children aged 6-12 years who presented to the Clinics of the Departments of Pediatric Dentistry and Orthodontics at Marmara University Faculty of Dentistry with an initial need for orthodontic treatment.

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neslihan Atmaca: lead
• Marmara University: collaborator

Study Sites (1)

Marmara Universty School of Dentistry

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Malocclusion; Anxiety Disorders

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Mental Disorders

Study Officials

• Neslihan Atmaca, Doctor of Dental Surgery

  Marmara Universty Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 9, 2026
• Study Start: May 15, 2024
• Primary Completion: November 20, 2024
• Study Completion: May 15, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified individual participant data (IPD), along with supporting documents such as the study protocol and statistical analysis plan, will be available beginning 6 months after publication of the primary study results and will remain available for 5 years following the publication date.
• Access Criteria: Requests for access to de-identified individual participant data and supporting documents will be considered for academic or scientific research purposes. Interested researchers must submit a written proposal detailing the planned analysis, including objectives and statistical methods. Requests will be reviewed by the principal investigator and institutional review board (IRB) representatives to ensure ethical compliance and scientific merit. A data use agreement must be signed prior to data release. Requests can be submitted via email to the corresponding author listed in the publication.

Locations

TU (1)