- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07814794
Augmented Reality Dentistry (AugRealDent)
Augmented Reality-assisted Dental Treatments
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Giuseppe D'Albis, Dr.
- Telefonnummer: +393495103642
- E-mail: giuseppe.dalbis@uniba.it
Undersøgelse Kontakt Backup
- Navn: Mahmoud H. Raheel, Dr.
- Telefonnummer: +20 10 23090373
- E-mail: Mahmoud_rahel10@yahoo.com
Studiesteder
-
-
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Bari, Italien, 70042
- University of Bari Aldo Moro
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Kontakt:
- Giuseppe D'Albis, Dr.
- Telefonnummer: +393495103642
- E-mail: giuseppe.dalbis@uniba.it
-
Ledende efterforsker:
- Giuseppe D'Albis, Dr
-
Kontakt:
- Mahmoud H. Raheel, Dr.
- Telefonnummer: +20 10 23090373
- E-mail: Mahmoud_rahel10@yahoo.com
-
Ledende efterforsker:
- Mahmoud H. Raheel, Dr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Good health according to the System of the American Society of Anesthesiology
- Aged older than 18 years
- No general medical contraindication for surgery or orthodontics
Exclusion Criteria:
Smoking more than 15 cigarettes a day
- Pregnancy
- Acute infections
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Patients requiring dental treatment
Patients requiring dental treatment, including tooth extraction, dental implant placement, or orthodontic treatment, for whom CBCT imaging and intraoral scanning are clinically indicated and who are eligible for augmented reality-assisted treatment.
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Performance of oral surgical procedures using augmented reality to visualize and identify anatomical landmarks.
Dental and oral surgical procedures will be performed using augmented reality guidance, which provides real-time visualization of the preoperative treatment plan and relevant anatomical landmarks.
AR guidance will be used to support procedures such as tooth extractions, dental implant placement, and orthodontic treatments, allowing the operator to follow the virtually planned treatment during the clinical procedure.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Accuracy of Osteotomies and Odontotomies Assessed by Linear and Angular Deviation from the Preoperative Surgical Plan
Tidsramme: 1 month
|
Postoperative imaging will be superimposed on the preoperative virtual surgical plan, and the deviation between the planned and achieved osteotomy/odontotomy will be quantified.
Accuracy will be assessed using linear deviation, expressed in millimeters (mm), and, where applicable, angular deviation, expressed in degrees (°).
Measurements will include the discrepancy in the position, extent, and orientation of the performed surgical cuts relative to the corresponding planned cuts.
For each osteotomy or odontotomy, the measured deviations will be recorded and summarized using descriptive statistics, including mean, standard deviation, median, range, and 95% confidence intervals, as appropriate.
|
1 month
|
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Accuracy of Freehand Three-Dimensional Orthodontic Bracket Positioning Assessed by Linear and Angular Deviations from the Planned Position
Tidsramme: 1 month
|
The accuracy of freehand orthodontic bracket placement will be evaluated by comparing the clinically achieved bracket position with the predefined three-dimensional virtual bracket position. Digital models obtained after bracket placement will be superimposed on the corresponding preoperative digital models or virtual treatment plan. Three-dimensional discrepancies between the planned and achieved bracket positions will be quantified for each bracket. Accuracy will be assessed using linear deviations, expressed in millimeters (mm), along the mesiodistal, occlusogingival, and buccolingual axes, as well as angular deviations, expressed in degrees (°), including tip, torque, and rotational discrepancies. For each bracket, the measured deviations will be recorded and summarized using descriptive statistics, including mean, standard deviation, median, range, and 95% confidence intervals, as appropriate. Aggregate values may also be calculated at the patient and study-group levels. |
1 month
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Giuseppe D'Albis, Dr, University of Bari Aldo Moro
- Studiestol: Saverio Capodiferro, Prof, University of Bari Aldo Moro
- Ledende efterforsker: Mahmoud H. Raheel, Dr., Orthodontics Department of Minya University
- Studiestol: Wael M. Refai, Prof., Minia University
- Ledende efterforsker: Kareem M. Gaber, Dr., Minia University
Publikationer og nyttige links
Generelle publikationer
- Thomas AA, Sivakumar A. An evaluation of the accuracy of bracket positioning with and without loupes using 3Shape Ortho Analyzer software. J Taibah Univ Med Sci. 2022 Sep 16;18(1):98-103. doi: 10.1016/j.jtumed.2022.08.010. eCollection 2023 Feb.
- Kwon HB, Park YS, Han JS. Augmented reality in dentistry: a current perspective. Acta Odontol Scand. 2018 Oct;76(7):497-503. doi: 10.1080/00016357.2018.1441437. Epub 2018 Feb 21.
- Strobele DA, Othman A, Meier MA, Aboulazm K, von See C. Augmented reality in orthodontics for bracket placement using conventional mobile devices: Technical note. J World Fed Orthod. 2023 Dec;12(6):280-283. doi: 10.1016/j.ejwf.2023.08.003. Epub 2023 Sep 13.
- Macrì, M.; D'Albis, G.; D'Albis, V.; Timeo, S.; Festa, F. Augmented Reality-Assisted Surgical Exposure of an Impacted Tooth: A Pilot Study. Appl. Sci. 2023, 13, 11097. https://doi.org/10.3390/app131911097
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AugRealDent2
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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