Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
14 maja 2026 zaktualizowane przez: 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
Przegląd badań
Status
Aktywny, nie rekrutujący
Warunki
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
48
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
-
Ankara, Turcja (Türkiye), 06490
- Baskent University Faculty of Dentistry, Department of Orthodontics
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Nie
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
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.
Inne nazwy:
|
|
Eksperymentalny: 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.
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in maxillary transverse skeletal width and intermolar width from T0 to T2
Ramy czasowe: -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.
|
-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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Wong-Baker FACES Pain Rating Scale score
Ramy czasowe: -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)
|
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.
|
-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)
Ramy czasowe: -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)
|
|
Modified Silness-Löe Plaque Index score
Ramy czasowe: -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 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.
|
-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)
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
3D digital model superimposition-based surface deviation
Ramy czasowe: -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)
|
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.
|
-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)
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Krzesło do nauki: Habibe Sinem Ince Bingol, DDS, Orthodontist, Hacettepe Unversity, Faculty of Dentistry, Department of Orthodontics
- Główny śledczy: Sinem Tekdemir, DDS, Baskent University, Faculty of Dentistry, Department of Orthodontics
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
7 sierpnia 2025
Zakończenie podstawowe (Szacowany)
1 lipca 2026
Ukończenie studiów (Szacowany)
1 września 2026
Daty rejestracji na studia
Pierwszy przesłany
23 lutego 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
14 maja 2026
Pierwszy wysłany (Rzeczywisty)
20 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
20 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
14 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- D-KA24/41
- 2025-066 (Inny identyfikator: Turkish Medicines and Medical Devices Agency Clinical Trial Authorization Number)
- 25/31 (Inny identyfikator: Baskent University Institutional Ethics Committee Approval Number)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
Individual participant data (IPD) will not be shared due to institutional policies, ethical committee regulations, and patient confidentiality considerations.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Laboratory-fabricated rapid maxillary expansion appliance
-
National Research Centre, EgyptAl-Azhar UniversityRekrutacyjnyWady zgryzu | Ugryzienie krzyżowe | Zgryz krzyżowy | Zwężenie szczękiEgipt