Active — Not RecruitingNot Applicable

Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency

Turkey (Türkiye)75 participantsStarted 2025-05-26

Plain-language summary

he primary aim of this study is to compare the dentoalveolar and skeletal effects of arch expansion using an in-house clear aligner system, produced chairside with an indirect manufacturing technique, and commercially available clear aligner systems (Invisalign) in patients during the mixed dentition period. Participants will be allocated into five groups: Group A-In-house aligners (5-day activation protocol), Group B-In-house aligners (2-day activation protocol), Group C-Invisalign First aligners, Group D-Invisalign Palatal Expander, and Group E-untreated control group. Before treatment, demographic data, dental models, intraoral and extraoral photographs, radiographic images, and clinical measurements will be collected. Skeletal measurements, including maxillary and nasal widths, will be evaluated using posteroanterior cephalometric radiographs. Digital models of the maxilla and mandible will be obtained using an intraoral scanner and used for dental measurements before and after treatment. Secondary outcomes include evaluation of facial soft tissue changes using stereophotogrammetry (3DMD), assessment of white spot lesions using quantitative light-induced fluorescence (QLF), and analysis of patient compliance using the Orthodontic Patient Cooperation Scale. In addition, changes in body mass index (BMI), maxillary-mandibular transverse discrepancies, and appliance wear time will be evaluated.

Who can participate

Age range

7 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients in the early mixed dentition period; * Maxillary intermolar width ≤ 31 mm; * Presence of at least 5 mm transverse discrepancy between the maxillary and mandibular arches; * Normal vertical growth pattern (Sn-GoGn: 32 ± 6°); * Eruption of permanent first molars and central incisors; * Presence of at least two primary posterior teeth in each quadrant; * Posterior teeth with a clinical crown height of at least 4 mm; * Patients aged between 7 and 10 years; * Absence of any craniofacial anomalies; * Good oral hygiene status; Healthy periodontal tissues. Exclusion Criteria: * Patients with the loss of more than one primary tooth * Presence of stainless steel crowns on the maxillary permanent first molars, primary first molars, or primary second molars * Patients with systemic or syndromic conditions * Presence of palatal exostoses or morphological anomalies of the palatal surface * Presence of active temporomandibular joint disorders * Children with poor compliance * History of allergy to any dental material * Patients with multiple and/or advanced caries, tooth agenesis, or supernumerary teeth * Patients with skeletal asymmetry

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maxillary Transverse Dentoalveolar Dimension

Timeframe: 20 weeks

Trial details

NCT IDNCT07586163

SponsorTC Erciyes University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Maxillary Transverse Deficiency trials