- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07814794
Augmented Reality Dentistry (AugRealDent)
Augmented Reality-assisted Dental Treatments
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Giuseppe D'Albis, Dr.
- Phone Number: +393495103642
- Email: giuseppe.dalbis@uniba.it
Study Contact Backup
- Name: Mahmoud H. Raheel, Dr.
- Phone Number: +20 10 23090373
- Email: Mahmoud_rahel10@yahoo.com
Study Locations
-
-
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Bari, Italy, 70042
- University of Bari Aldo Moro
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Contact:
- Giuseppe D'Albis, Dr.
- Phone Number: +393495103642
- Email: giuseppe.dalbis@uniba.it
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Principal Investigator:
- Giuseppe D'Albis, Dr
-
Contact:
- Mahmoud H. Raheel, Dr.
- Phone Number: +20 10 23090373
- Email: Mahmoud_rahel10@yahoo.com
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Principal Investigator:
- Mahmoud H. Raheel, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of Osteotomies and Odontotomies Assessed by Linear and Angular Deviation from the Preoperative Surgical Plan
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Giuseppe D'Albis, Dr, University of Bari Aldo Moro
- Study Chair: Saverio Capodiferro, Prof, University of Bari Aldo Moro
- Principal Investigator: Mahmoud H. Raheel, Dr., Orthodontics Department of Minya University
- Study Chair: Wael M. Refai, Prof., Minia University
- Principal Investigator: Kareem M. Gaber, Dr., Minia University
Publications and helpful links
General Publications
- 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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AugRealDent2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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