Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
3 septembre 2026 mis à jour par: Baskent University
Comparison of the Skeletal and Dentoalveolar Effects and Patient Comfort of Conventional and 3D-Printed Maxillary Expansion Appliances in Mixed Dentition Patients
The goal of this clinical trial is to determine whether two types of rapid maxillary expansion (RME) appliances produce different outcomes in children. RME is a treatment utilized to expand a narrow upper jaw. This study will include children aged 8 to 10 years who need upper jaw expansion during the mixed dentition period (when they have both temporary and permanent teeth).
The main questions this study aims to answer are:
- Do 3D-printed expansion appliances produce different skeletal and dental changes compared to conventionally fabricated appliances?
- Do children feel more comfortable with one type of appliance?
- Is there a difference in pain levels or oral hygiene between the two groups?
Researchers aimed to compare a conventionally fabricated expansion appliance manufactured in a dental laboratory with a 3D-printed expansion appliance produced digitally to determine whether the method of production affects treatment outcomes and patient comfort.
Participants:
- Being treated with one of the two expansion appliances (assigned randomly)
- Follow a standard activation protocol at home with parental guidance
- Attend regular clinic visits during expansion and retention phases
- Have dental photographs, X-rays, and digital scans taken before and after treatment
- Complete an oral health-related quality of life questionnaire
- Rate their pain using a pain scale
- Have their oral hygiene measured
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Description détaillée
Treatment effectiveness, amount of expansion, and patient comfort will be evaluated between the two groups. Additionally, the impact of digital appliance production on treatment outcomes and patient satisfaction will be investigated.
This prospective, parallel-group, randomized clinical trial aims to compare the skeletal, dentoalveolar, and patient-reported effects of conventionally fabricated and three-dimensional (3D) printed rapid maxillary expansion (RME) appliances in children with transverse maxillary deficiency during the mixed dentition period.
Participants aged 8-10 years who meet the predefined inclusion criteria and require rapid maxillary expansion as part of their orthodontic treatment will be enrolled.
The results are expected to contribute evidence-based guidance for orthodontists when selecting appliance fabrication methods, balancing biological effectiveness with patient comfort and quality-of-life considerations.
Findings from this study may also support future digital workflow integration strategies in pediatric orthodontic treatment planning.
Type d'étude
Interventionnel
Inscription (Réel)
48
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Ankara, Turquie (Türkiye), 06490
- Baskent University Faculty of Dentistry, Department of Orthodontics
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Children aged between 7 and 11 years
- In the mixed dentition period
- Fully erupted permanent first molars
- Presence of primary canines and primary second molars suitable for use as anchorage units for at least 6 months
- Angle Class I or Class II molar relationship
- Presence of posterior crossbite and/or moderate maxillary transverse deficiency or moderate crowding
- Prepubertal growth stage corresponding to Cervical Vertebral Maturation Stage 1 (CVM1) or Stage 2 (CVM2)
- Receiving orthodontic treatment at the Başkent University Department of Orthodontics
- Parents or legal guardians willing to provide written informed consent
Exclusion Criteria:
- Previous orthodontic treatment
- Periodontal disease
- Enamel hypocalcification or significant calcium deficiency
- Root resorption
- Signs or symptoms of temporomandibular joint dysfunction
- Angle Class III molar relationship
- Craniofacial syndromes
- Cleft lip and/or palate
- Known allergy to acrylic materials or metal alloys
- Inability to maintain adequate oral hygiene during treatment
- Lack of cooperation during treatment
- Repeated appliance breakage or dislodgement (three or more times)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Laboratory-fabricated rapid maxillary expansion appliance
Participants are treated with a laboratory-fabricated rapid maxillary expansion (RME) appliance produced on a dental cast obtained from conventional impressions.
The arms of the palatal expansion screw are adapted and soldered to orthodontic molar bands on the cast model.
Following adaptation, acrylic resin is added in the palatal region to increase the force distribution area.
The appliance is cemented to the teeth using glass ionomer cement.
Activation and retention protocols are standardized across both groups.
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A rapid maxillary expansion (RME) appliance fabricated on a dental cast obtained from conventional impressions.
The expansion screw arms are adapted and soldered to orthodontic molar bands on the cast.
Autres noms:
|
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Expérimental: 3D-printed rapid maxillary expansion appliance
Participants are treated with a rapid maxillary expansion (RME) appliance fabricated using digital intraoral scans.
Dental models are generated from intraoral scan data, and the appliance framework, including the arms and tooth-supporting components, is manufactured as a single-piece structure using three-dimensional (3D) metal printing technology with sintered cobalt-chromium alloy.
After fabrication, acrylic resin is added to the palatal region to increase the force distribution area.
The appliance is cemented to the teeth using glass ionomer cement.
Activation and retention protocols are standardized across both groups.
|
A rapid maxillary expansion (RME) appliance fabricated using digital intraoral scan data.
Dental models are generated from intraoral scans, and the appliance framework is manufactured as a single-piece structure using three-dimensional (3D) metal printing with sintered cobalt-chromium alloy.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in maxillary transverse skeletal width and intermolar width from T0 to T2
Délai: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
|
The primary outcome is the difference in transverse skeletal maxillary width and maxillary intermolar width between baseline (T0) and the end of the 3-month retention period (T2).
Skeletal measurements will be obtained from standardized posteroanterior cephalometric radiographs, and dental measurements will be obtained from digital model analysis.
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-Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Wong-Baker FACES Pain Rating Scale score
Délai: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
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Pain perception will be assessed using the Wong-Baker FACES Pain Rating Scale at predefined time points during treatment.
Scores will be recorded and compared between groups.
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-Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
|
|
Child Perceptions Questionnaire (CPQ 8-10)
Délai: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
|
Oral health-related quality of life will be assessed using the validated Child Perceptions Questionnaire (CPQ 8-10).
Total and domain scores (oral symptoms, functional limitations, emotional well-being, social well-being) will be recorded and compared between groups.
|
-Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
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Modified Silness-Löe Plaque Index score
Délai: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
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Oral hygiene status will be evaluated using the Modified Silness-Löe Plaque Index at predefined time points during treatment to monitor plaque accumulation and compare oral hygiene changes between groups.
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-Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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3D digital model superimposition-based surface deviation
Délai: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
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Digital models obtained at T0 and T2 will be superimposed using the medial two-thirds of the third palatal rugae and the posterior palatal vault as stable reference areas.
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-Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Habibe Sinem Ince Bingol, DDS, Orthodontist, Hacettepe Unversity, Faculty of Dentistry, Department of Orthodontics
- Chercheur principal: Sinem Tekdemir, DDS, Baskent University, Faculty of Dentistry, Department of Orthodontics
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
7 août 2025
Achèvement primaire (Réel)
31 juillet 2026
Achèvement de l'étude (Estimé)
1 décembre 2026
Dates d'inscription aux études
Première soumission
23 février 2026
Première soumission répondant aux critères de contrôle qualité
14 mai 2026
Première publication (Réel)
20 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- D-KA24/41
- 2025-066 (Autre identifiant: Turkish Medicines and Medical Devices Agency Clinical Trial Authorization Number)
- 25/31 (Autre identifiant: Baskent University Institutional Ethics Committee Approval Number)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data (IPD) will not be shared due to institutional policies, ethical committee regulations, and patient confidentiality considerations.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .