NCT07814794

Brief Summary

This study aims to evaluate the accuracy of augmented reality (AR)-assisted dental procedures. Patient-specific anatomical data will be acquired using cone-beam computed tomography (CBCT) and intraoral scanning and integrated to create a three-dimensional virtual model for treatment planning. Different dental procedures, including tooth extractions, dental implant placement, and orthodontic procedures, will be virtually planned before treatment. During the clinical procedure, the planned anatomical and procedural information will be visualized through an AR system, providing real-time guidance to the operator. The accuracy of AR-assisted treatment will be assessed by comparing the preoperative virtual plan with the postoperative clinical outcome, evaluating deviations between planned and achieved results.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Sep 2026Nov 2026

First Submitted

Initial submission to the registry

August 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

1 month

First QC Date

August 29, 2026

Last Update Submit

September 24, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Accuracy of Osteotomies and Odontotomies Assessed by Linear and Angular Deviation from the Preoperative Surgical Plan

    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

  • Accuracy of Freehand Three-Dimensional Orthodontic Bracket Positioning Assessed by Linear and Angular Deviations from the Planned Position

    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

Study Arms (1)

Patients requiring dental treatment

EXPERIMENTAL

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.

Procedure: SurgeryProcedure: Patients requiring orthodontic treatment.

Interventions

SurgeryPROCEDURE

Performance of oral surgical procedures using augmented reality to visualize and identify anatomical landmarks.

Patients requiring dental treatment

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.

Patients requiring dental treatment

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Smoking more than 15 cigarettes a day
  • Pregnancy
  • Acute infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bari Aldo Moro

Bari, 70042, Italy

Location

Related Publications (4)

  • 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.

    PMID: 36398025BACKGROUND
  • 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.

    PMID: 29465283BACKGROUND
  • 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.

    PMID: 37709634BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Malocclusion

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Giuseppe D'Albis, Dr

    University of Bari Aldo Moro

    PRINCIPAL INVESTIGATOR
  • Mahmoud H. Raheel, Dr.

    Orthodontics Department of Minya University

    PRINCIPAL INVESTIGATOR
  • Wael M. Refai, Prof.

    Minia University

    STUDY CHAIR
  • Saverio Capodiferro, Prof

    University of Bari Aldo Moro

    STUDY CHAIR
  • Kareem M. Gaber, Dr.

    Minia University

    PRINCIPAL INVESTIGATOR
  • Vincenzo D'Albis, Dr.

    University "G. d'Annunzio" Chieti - Pescara

    PRINCIPAL INVESTIGATOR
  • Michele D'Attilio, Prof.

    University "G. d'Annunzio" Chieti - Pescara

    STUDY CHAIR

Central Study Contacts

Giuseppe D'Albis, Dr.

CONTACT

Mahmoud H. Raheel, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 29, 2026

First Posted

September 11, 2026

Study Start

September 1, 2026

Primary Completion

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

September 25, 2026

Record last verified: 2026-09

Locations