EdentulismAugRealDentNCT07814794
Augmented Reality Dentistry
A study testing Surgery and Patients requiring orthodontic treatment. in people with Edentulism and Malocclusion; Displaced Teeth, run by University of Bari Aldo Moro at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Edentulism, Malocclusion; Displaced Teeth, TEETH EXTRACTION
- What is being tested?
- Surgery and Patients requiring orthodontic treatment.
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Smoking more than 15 cigarettes a day
- Pregnancy
- Acute infections
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
University of Bari Aldo Moro
Bari, 70042
Giuseppe D'Albis, Dr., +393495103642, giuseppe.dalbis@uniba.it
Mahmoud H. Raheel, Dr., +20 10 23090373, Mahmoud_rahel10@yahoo.com
About this study
Official title: Augmented Reality-assisted Dental Treatments
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.
- Conditions
- Edentulism, Malocclusion; Displaced Teeth, TEETH EXTRACTION
- Being tested
- Surgery, Patients requiring orthodontic treatment.
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Performance of oral surgical procedures using augmented reality to visualize and identify anatomical landmarks.
Patients requiring orthodontic treatment.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Surgery; Procedure: Patients requiring orthodontic treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari Aldo Moro
- Sponsor type
- University, hospital or other
- Collaborators
- Minia University
- Responsible party
- Principal investigator, Giuseppe D'Albis, University of Bari Aldo Moro
- Investigators
- Giuseppe D'Albis, Dr, Principal investigator, University of Bari Aldo MoroMahmoud H. Raheel, Dr., Principal investigator, Orthodontics Department of Minya UniversityWael M. Refai, Prof., Study chair, Minia UniversitySaverio Capodiferro, Prof, Study chair, University of Bari Aldo MoroKareem M. Gaber, Dr., Principal investigator, Minia UniversityVincenzo D'Albis, Dr., Principal investigator, University "G. d'Annunzio" Chieti - PescaraMichele D'Attilio, Prof., Study chair, University "G. d'Annunzio" Chieti - Pescara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814794
- Sponsor's protocol ID
- AugRealDent2
- Acronym
- AugRealDent
- Status last verified
- Sep 2026
- First submitted
- 29 Aug 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 36398025Kwon 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.
PubMed 29465283Strobele 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.
PubMed 37709634Macrì, 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 at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality-assisted Dental Treatments
- ClinicalTrials.gov ID
- NCT07814794
- Acronym / sponsor ID
- AugRealDent / AugRealDent2
- Conditions
- Edentulism, Malocclusion; Displaced Teeth, TEETH EXTRACTION
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Bari Aldo MoroUniversity, hospital or other
- Collaborators
- Minia University
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring dental treatment | Experimental | Procedure: Surgery, Procedure: Patients requiring orthodontic 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Smoking more than 15 cigarettes a day
- Pregnancy
- Acute infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryPerformance of oral surgical procedures using augmented reality to visualize and identify anatomical landmarks. | Procedure or surgery | Patients requiring dental treatment |
| Patients requiring orthodontic 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. | Procedure or surgery | Patients requiring dental treatment |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 36398025Thomas 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.
- Background: PubMed 29465283Kwon 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.
- Background: PubMed 37709634Strobele 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.
- BackgroundMacrì, 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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giuseppe D'Albis, Dr principal investigator
University of Bari Aldo Moro
Mahmoud H. Raheel, Dr. principal investigator
Orthodontics Department of Minya University
Wael M. Refai, Prof. study chair
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery and Patients requiring orthodontic treatment. in people with Edentulism and Malocclusion; Displaced Teeth, run by University of Bari Aldo Moro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe D'Albis, Dr. (+393495103642, giuseppe.dalbis@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Osteotomies and Odontotomies Assessed by Linear and Angular Deviation from the Preoperative Surgical Plan (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07814794, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.