Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency
Comparison of the Effectiveness of Different Clear Aligner Systems in Patients With Maxillary Transverse Deficiency During the Mixed Dentition Period: An In-Vivo Randomized Controlled Clinical Trial
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.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kayseri
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Talas, Kayseri, 터키 (Türkiye), 38039
- Erciyes University Faculty of Dentistry
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 대조군
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실험적: Invisalign Palatal Expander
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In patients treated with the Invisalign Palatal Expander (IPE) (Align Technology, Santa Clara, CA), three-dimensional digital models were obtained using an intraoral scanner (iTero Lumina™, Align Technology).
Individualized maxillary expansion amounts were prescribed based on clinical objectives.
Unlike conventional aligner therapy, the IPE system does not involve full digital treatment simulation; expansion was defined by the planned transverse increase.
Following approval, customized IPE appliance sets were manufactured and delivered.
Patients were instructed to wear the appliance full-time, including during meals, removing it only for oral hygiene procedures.
The activation protocol consisted of appliance changes every 2 days, providing 0.25 mm transverse expansion per stage.
After completion of expansion, retention was achieved using Invisalign Palatal Holder appliances fabricated from new digital scans.
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실험적: In-House Aligner (2-Day Protocol)
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In-house clear aligners were fabricated using a fully digital workflow.
Digital impressions were obtained with an intraoral scanner (3Shape TRIOS), and maxillary models were processed in CAD software for segmentation and attachment planning.
Buccal retention attachments were placed on primary canines, primary molars, and permanent first molars.
Maxillary models were digitally expanded in 0.2 mm increments per stage, generating sequential STL files.
Models were 3D-printed and thermoformed to fabricate aligners, which were then trimmed, polished, and labeled.
Patients received five aligners at each visit and were instructed to change them every 2 days.
Follow-up visits were scheduled at 10-day intervals.
At each visit, treatment progress was assessed, and the next series of aligners was provided.
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실험적: In-House Aligner (5-Day Protocol)
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In-house clear aligners were fabricated using a fully digital workflow.
Digital impressions were obtained with an intraoral scanner (3Shape TRIOS), and maxillary models were processed in CAD software for segmentation and attachment planning.
Buccal retention attachments were placed on primary canines, primary molars, and permanent first molars to enhance retention and support transverse expansion.
Models were digitally expanded in 0.2 mm increments per stage and converted into sequential STL files.
These models were 3D-printed (Asiga MAX UV) and thermoformed (MINISTAR S) to produce aligners.
The appliances were trimmed, polished, and labeled with sequence numbers.
Patients received five aligners per visit and were instructed to change them every 5 days.
Follow-up visits were scheduled at 25-day intervals, during which treatment progress was evaluated and new aligners were delivered.
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활성 비교기: Invisalign First Aligner
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In patients treated with Invisalign First (Align Technology, Santa Clara, CA), three-dimensional digital models were obtained using an intraoral scanner (3Shape TRIOS).
Intraoral, extraoral photographs and radiographs were collected and uploaded to the ClinCheck digital treatment planning platform.
Individualized treatment objectives were defined, and expansion was planned without concurrent tooth movement to isolate maxillary transverse effects.
After achieving the desired expansion, comprehensive orthodontic treatment was continued.
Virtual treatment plans were reviewed and revised when necessary before approval.
Attachments were placed on posterior teeth to enhance retention and support expansion.
Enamel surfaces were etched, bonded, and light-cured using standard orthodontic protocols.
Patients were instructed to wear aligners 20-22 hours daily,and aligners were replaced every 5 days.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Maxillary Transverse Dentoalveolar Dimension
기간: 20 weeks
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20 weeks
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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White spot lesion incidence
기간: 20 weeks
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20 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025/189
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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