- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07705009
Intraoral Scanning Versus Alginate Impressions in Dental Students
Procedure Time and Patient Comfort of Intraoral Scanning Versus Alginate Impressions Among Dental Students: A Randomized Clinical Trial
Dental impressions are used to create a record of a person's teeth and oral structures. Conventional impressions are made using impression material placed in a tray, whereas digital impressions are obtained using an intraoral scanner.
This randomized clinical trial compared conventional alginate impressions with digital intraoral scanning using the TRIOS 3 and Medit i700 scanners among dental students aged 18 to 24 years. Participants were randomly assigned to one of the three impression techniques. Each participant underwent recording of both the upper and lower dental arches using the assigned technique.
The study primarily compared the chairside time required for each technique and the participants' experience immediately after the procedure. Comfort, nausea, breathing, pain, dry-mouth sensation, perceived procedure speed, overall satisfaction, and preference for conventional or digital impressions were also evaluated.
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Huế, Wietnam, 530000
- Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Undergraduate dental students at the University of Medicine and Pharmacy, Hue University.
- Aged 18 to 24 years.
- Willing to undergo one maxillary and one mandibular dental impression using the assigned technique.
- Willing and able to complete the study questionnaire.
- Provided written informed consent.
Exclusion Criteria:
- Currently undergoing orthodontic treatment.
- Presence of a systemic disease or acute condition that limited the ability to cooperate or increased the risk of discomfort during impression taking or intraoral scanning, including an acute respiratory disorder or frequent vomiting.
- Limited mouth opening or an oral and maxillofacial condition that prevented correct impression-tray seating or scanner-tip placement according to the study protocol.
- A maxillofacial abnormality that markedly affected the procedure or caused significant recording distortion.
- An excessive gag reflex that prevented completion of the assigned procedure.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Diagnostyczny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: Conventional Alginate Impression
Participants underwent maxillary and mandibular conventional impressions using alginate impression material and stock trays according to the manufacturer's instructions.
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Maxillary and mandibular conventional impressions were obtained using Tropical alginate impression material and stock trays.
The alginate was mixed, placed in the impression tray, and used according to the manufacturer's instructions.
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Eksperymentalny: TRIOS 3 Intraoral Scanning
Participants underwent full-arch maxillary and mandibular digital impressions and bite registration using the TRIOS 3 intraoral scanner according to the manufacturer's recommended scanning protocol.
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Maxillary and mandibular full-arch digital impressions were obtained using the TRIOS 3 intraoral scanner according to the manufacturer's recommended scanning protocol.
A bite-registration scan was also obtained.
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Eksperymentalny: Medit i700 Intraoral Scanning
Participants underwent full-arch maxillary and mandibular digital impressions and bite registration using the Medit i700 intraoral scanner according to the manufacturer's recommended scanning protocol.
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Maxillary and mandibular full-arch digital impressions were obtained using the Medit i700 intraoral scanner according to the manufacturer's recommended scanning protocol.
A bite-registration scan was also obtained.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Total Chairside Procedure Time
Ramy czasowe: During the assigned impression procedure at the single study visit
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Total chairside procedure time was measured in seconds using a digital stopwatch and calculated as the sum of the recorded procedural stages.
For the conventional alginate group, the stages included maxillary mixing, maxillary impression taking, mandibular mixing, and mandibular impression taking.
For the digital groups, the stages included patient and case information entry, maxillary scanning, and mandibular scanning.
Bite-registration time was excluded from the total procedure time because there was no equivalent stage in the conventional alginate workflow.
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During the assigned impression procedure at the single study visit
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Patient-Reported Overall Comfort During the Impression Procedure
Ramy czasowe: Immediately after completion of the assigned impression procedure
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Overall comfort during the assigned impression procedure was assessed immediately after the procedure using a 0-to-100 visual analogue scale.
Higher scores indicated greater comfort.
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Immediately after completion of the assigned impression procedure
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Van Nhat Thang Le, DDS PhD, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- H2025/074
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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