Partially Edentulous MandiblePhase 4ImplantNCT07523815
Artificial Intelligence Assisted Workflow Versus Conventional Workflow in Guided Implant Placement
A Phase 4 study testing AI assisted implant placement and Conventional computer guided implant placement in people with Partially Edentulous Mandible, run by Sandra Moussa Botros El Tarzi at 1 site in Egypt.
Trial summary
The AI assisted CAD/CAM workflow will be adopted for the treatment planning and guide design generation with the aim of comparing precision of implant placement with conventional digital workflow. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Partially Edentulous Mandible
- What is being tested?
- AI assisted implant placement and Conventional computer guided implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2026to 1 Dec 2026
- Phase
- Phase 4
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Kennedy class III partially edentulous patient with or without modifications.
- Patients who need single implant posterior site delayed implant placement.
- Patients above 18 and below 60 years of age.
- Natural healthy neighboring teeth without need of new restorations.
Who cannot join
- Patients with D4 bone density.
- Patients with known systemic or local diseases or treatments which can affect normal tissue healing.
- Patients who are heavy smokers.
- Presence of signs of active infection or pus formation.
- Patients with a need for implants in the anterior region.
- Additional oral surgery in the region of interest.
- Need For Bone grafting.
- Pregnant and/or lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry - Cairo University
Cairo, Manial
Nehal I Shobair, Teacher, 00201063666985, nehal.shobair@miuegypt.edu.eg
About this study
Official title: Assessment of the Accuracy of Artificial Intelligence Assisted Workflow Versus Conventional Workflow in Computer Guided Implant Placement: A Randomized Controlled Clinical Trial.
The AI assisted CAD/CAM workflow will be adopted for the treatment planning and guide design generation with the aim of comparing precision of implant placement with conventional digital workflow.
Read the detailed description
The study will be conducted in Oral and Maxillofacial Department, Faculty of Oral and Dental Medicine, Cairo University.After patient's selection, the CBCTs will be captured for the edentulous area along with a full arch PVS impression for the upper and lower arches. The patients will then be randomly allocated into two groups. Group I, AI assisted group, the AI assisted workflow will be adopted for the treatment planning and guide design generation. Then, the surgical guide with the embedded sleeve will be designed and 3D printed. For Group II, Static CAIS group, the virtual implant planning for all patients will be done by one qualified experienced dentist in implant dentistry. Then, the surgical guide with the embedded sleeve will be designed and 3D printed with computer-aided design/computer-aided manufacturing (CAD/CAM) technology. The guides will then be disinfected to be ready for the surgical procedure. All patients will be administered 400 mg Ibuprofen 1 hour prior to surgery and will be instructed to rinse with a 0.12% Chlorhexidine solution for 60 s. After administration of local anesthesia,implant placement will be performed according to the allocated treatment protocol by one experienced surgeon. The following process will be the same for both guided techniques. The fit and stability of the 3D surgical guide will be verified prior to the surgery through tactile inspection and confirming the fit through the inspection window areas of the guide on top of the teeth. Implant bed preparations and implant insertions will be done through the 3D surgical guide in accordance with the manufacturer\'s fully guided surgical protocol. The drilling sequence will be followed as needed for each case. The implant will be placed via a fully guided implant placement regimen and a healing abutment will be placed for transmucosal healing. Wound suturing will be performed as needed and all the patients will receive postoperative instructions and will be appointed for a follow up and suture removal visit one week postoperatively. All patients will have an immediate postoperative CBCT.
The postoperative medications list will include systemic antibiotics (1 g of amoxicillin, twice a day) and an analgesic (500 mg of mefenamic acid, three times a day) for 5 days. For patients who were allergic to penicillin, 300 mg of clindamycin will be prescribed three times a day.
- Conditions
- Partially Edentulous Mandible
- Being tested
- AI assisted implant placement, Conventional computer guided implant placement
- Keywords
- Dental Implant, Implant Placement, Accuracy, Computer guided, CAIS, Implant planning, CAD/CAM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI assisted implant placementProcedure or surgery
the AI assisted workflow will be adopted for the treatment planning and guide design generation. Then, the surgical guide with the embedded sleeve will be designed and 3D printed.
Conventional computer guided implant placementProcedure or surgery
The virtual implant planning for all patients will be done by one qualified experienced dentist in implant dentistry. Then, the surgical guide with the embedded sleeve will be designed using the conventional CAD steps for static guide design and 3D printed with computer-aided design/computer-aided manufacturing (CAD/CAM) technology.
| Study group | Role | What they receive |
|---|---|---|
| Computer guided implant placement using artificial intelligence assisted designing and manufacturing | Active comparator | Not described Receives: Procedure: Conventional computer guided implant placement |
| Computer guided implant placement using conventional digital workflow in designing and manufacturing | Active comparator | Not described Receives: Procedure: AI assisted implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear Discrepancy
The linear implant position discrepancy between the plan and the actual implant position in millimeters will be assessed using a specialized software.
Measured: Immediate post operative
Angular Discrepancy
The angular implant position discrepancy between the plan and the actual implant position in degrees will be assessed using a specialized software.
Measured: Immediate post operative
CAD Timing
The time elapsed for AI assisted CAD, will be compared to time elapsed during conventional CAD workflow in seconds using a stopwatch.
Measured: Immediate post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Partially Edentulous MandibleStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sandra Moussa Botros El Tarzi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sandra Moussa Botros El Tarzi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523815
- Sponsor's protocol ID
- sandra.eltarzi1
- Acronym
- Implant
- Status last verified
- Aug 2025
- First submitted
- 6 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou W, Liu Z, Song L, Kuo CL, Shafer DM. Clinical Factors Affecting the Accuracy of Guided Implant Surgery-A Systematic Review and Meta-analysis. J Evid Based Dent Pract. 2018 Mar;18(1):28-40. doi: 10.1016/j.jebdp.2017.07.007. Epub 2017 Jul 22.
PubMed 29478680Younes F, Cosyn J, De Bruyckere T, Cleymaet R, Bouckaert E, Eghbali A. A randomized controlled study on the accuracy of free-handed, pilot-drill guided and fully guided implant surgery in partially edentulous patients. J Clin Periodontol. 2018 Jun;45(6):721-732. doi: 10.1111/jcpe.12897. Epub 2018 May 10.
PubMed 29608793Van de Velde T, Glor F, De Bruyn H. A model study on flapless implant placement by clinicians with a different experience level in implant surgery. Clin Oral Implants Res. 2008 Jan;19(1):66-72. doi: 10.1111/j.1600-0501.2007.01423.x. Epub 2007 Oct 22.
PubMed 17956565Takacs A, Hardi E, Cavalcante BGN, Szabo B, Kispelyi B, Joob-Fancsaly A, Mikulas K, Varga G, Hegyi P, Kivovics M. Advancing accuracy in guided implant placement: A comprehensive meta-analysis: Meta-Analysis evaluation of the accuracy of available implant placement Methods. J Dent. 2023 Dec;139:104748. doi: 10.1016/j.jdent.2023.104748. Epub 2023 Oct 19.
PubMed 37863173Smitkarn P, Subbalekha K, Mattheos N, Pimkhaokham A. The accuracy of single-tooth implants placed using fully digital-guided surgery and freehand implant surgery. J Clin Periodontol. 2019 Sep;46(9):949-957. doi: 10.1111/jcpe.13160. Epub 2019 Jul 19.
PubMed 31241782Shujaat S, Riaz M, Jacobs R. Synergy between artificial intelligence and precision medicine for computer-assisted oral and maxillofacial surgical planning. Clin Oral Investig. 2023 Mar;27(3):897-906. doi: 10.1007/s00784-022-04706-4. Epub 2022 Nov 3.
PubMed 36323803Shirmohammadi A, Ghertasi Oskouei S. The growing footprint of artificial intelligence in periodontology & implant dentistry. J Adv Periodontol Implant Dent. 2023 Jun 11;15(1):1-2. doi: 10.34172/japid.2023.012. eCollection 2023. No abstract available.
PubMed 37645551Murphy DC, Saleh DB. Artificial Intelligence in plastic surgery: What is it? Where are we now? What is on the horizon? Ann R Coll Surg Engl. 2020 Oct;102(8):577-580. doi: 10.1308/rcsann.2020.0158. Epub 2020 Aug 11.
PubMed 32777930Hung K, Montalvao C, Tanaka R, Kawai T, Bornstein MM. The use and performance of artificial intelligence applications in dental and maxillofacial radiology: A systematic review. Dentomaxillofac Radiol. 2020 Jan;49(1):20190107. doi: 10.1259/dmfr.20190107. Epub 2019 Aug 14.
PubMed 31386555Ersoy AE, Turkyilmaz I, Ozan O, McGlumphy EA. Reliability of implant placement with stereolithographic surgical guides generated from computed tomography: clinical data from 94 implants. J Periodontol. 2008 Aug;79(8):1339-45. doi: 10.1902/jop.2008.080059.
PubMed 18672982
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Accuracy of Artificial Intelligence Assisted Workflow Versus Conventional Workflow in Computer Guided Implant Placement: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07523815
- Acronym / sponsor ID
- Implant / sandra.eltarzi1
- Conditions
- Partially Edentulous Mandible
- Keywords
- Dental Implant, Implant Placement, Accuracy, Computer guided, CAIS, Implant planning, CAD/CAM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sandra Moussa Botros El TarziUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Apr 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.
The AI assisted CAD/CAM workflow will be adopted for the treatment planning and guide design generation with the aim of comparing precision of implant placement with conventional digital workflow.
Detailed description
The study will be conducted in Oral and Maxillofacial Department, Faculty of Oral and Dental Medicine, Cairo University.After patient's selection, the CBCTs will be captured for the edentulous area along with a full arch PVS impression for the upper and lower arches. The patients will then be randomly allocated into two groups. Group I, AI assisted group, the AI assisted workflow will be adopted for the treatment planning and guide design generation. Then, the surgical guide with the embedded sleeve will be designed and 3D printed. For Group II, Static CAIS group, the virtual implant planning for all patients will be done by one qualified experienced dentist in implant dentistry. Then, the surgical guide with the embedded sleeve will be designed and 3D printed with computer-aided design/computer-aided manufacturing (CAD/CAM) technology. The guides will then be disinfected to be ready for the surgical procedure. All patients will be administered 400 mg Ibuprofen 1 hour prior to surgery and will be instructed to rinse with a 0.12% Chlorhexidine solution for 60 s. After administration of local anesthesia,implant placement will be performed according to the allocated treatment protocol by one experienced surgeon. The following process will be the same for both guided techniques. The fit and stability of the 3D surgical guide will be verified prior to the surgery through tactile inspection and confirming the fit through the inspection window areas of the guide on top of the teeth. Implant bed preparations and implant insertions will be done through the 3D surgical guide in accordance with the manufacturer\'s fully guided surgical protocol. The drilling sequence will be followed as needed for each case. The implant will be placed via a fully guided implant placement regimen and a healing abutment will be placed for transmucosal healing. Wound suturing will be performed as needed and all the patients will receive postoperative instructions and will be appointed for a follow up and suture removal visit one week postoperatively. All patients will have an immediate postoperative CBCT.
The postoperative medications list will include systemic antibiotics (1 g of amoxicillin, twice a day) and an analgesic (500 mg of mefenamic acid, three times a day) for 5 days. For patients who were allergic to penicillin, 300 mg of clindamycin will be prescribed three times a day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer guided implant placement using artificial intelligence assisted designing and manufacturing | Active comparator | Procedure: Conventional computer guided implant placement |
| Computer guided implant placement using conventional digital workflow in designing and manufacturing | Active comparator | Procedure: AI assisted implant placement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Kennedy class III partially edentulous patient with or without modifications.
- Patients who need single implant posterior site delayed implant placement.
- Patients above 18 and below 60 years of age.
- Natural healthy neighboring teeth without need of new restorations.
Key exclusion criteria (8 listed)
- Patients with D4 bone density.
- Patients with known systemic or local diseases or treatments which can affect normal tissue healing.
- Patients who are heavy smokers.
- Presence of signs of active infection or pus formation.
- Patients with a need for implants in the anterior region.
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 |
|---|---|---|
| AI assisted implant placementthe AI assisted workflow will be adopted for the treatment planning and guide design generation. Then, the surgical guide with the embedded sleeve will be designed and 3D printed. | Procedure or surgery | Computer guided implant placement using conventional digital workflow in designing and manufacturing |
| Conventional computer guided implant placementThe virtual implant planning for all patients will be done by one qualified experienced dentist in implant dentistry. Then, the surgical guide with the embedded sleeve will be designed using the conventional CAD steps for static guide design and 3D printed with computer-aided design/computer-aided manufacturing (CAD/CAM) technology. | Procedure or surgery | Computer guided implant placement using artificial intelligence assisted designing and manufacturing |
Primary outcome
Linear Discrepancy
Time frame: Immediate post operative
The linear implant position discrepancy between the plan and the actual implant position in millimeters will be assessed using a specialized software.
Angular Discrepancy
Time frame: Immediate post operative
The angular implant position discrepancy between the plan and the actual implant position in degrees will be assessed using a specialized software.
CAD Timing
Time frame: Immediate post operative
The time elapsed for AI assisted CAD, will be compared to time elapsed during conventional CAD workflow in seconds using a stopwatch.
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 13 Apr 2026.
- Background: PubMed 29478680Zhou W, Liu Z, Song L, Kuo CL, Shafer DM. Clinical Factors Affecting the Accuracy of Guided Implant Surgery-A Systematic Review and Meta-analysis. J Evid Based Dent Pract. 2018 Mar;18(1):28-40. doi: 10.1016/j.jebdp.2017.07.007. Epub 2017 Jul 22.
- Background: PubMed 29608793Younes F, Cosyn J, De Bruyckere T, Cleymaet R, Bouckaert E, Eghbali A. A randomized controlled study on the accuracy of free-handed, pilot-drill guided and fully guided implant surgery in partially edentulous patients. J Clin Periodontol. 2018 Jun;45(6):721-732. doi: 10.1111/jcpe.12897. Epub 2018 May 10.
- Background: PubMed 17956565Van de Velde T, Glor F, De Bruyn H. A model study on flapless implant placement by clinicians with a different experience level in implant surgery. Clin Oral Implants Res. 2008 Jan;19(1):66-72. doi: 10.1111/j.1600-0501.2007.01423.x. Epub 2007 Oct 22.
- Background: PubMed 37863173Takacs A, Hardi E, Cavalcante BGN, Szabo B, Kispelyi B, Joob-Fancsaly A, Mikulas K, Varga G, Hegyi P, Kivovics M. Advancing accuracy in guided implant placement: A comprehensive meta-analysis: Meta-Analysis evaluation of the accuracy of available implant placement Methods. J Dent. 2023 Dec;139:104748. doi: 10.1016/j.jdent.2023.104748. Epub 2023 Oct 19.
- Background: PubMed 31241782Smitkarn P, Subbalekha K, Mattheos N, Pimkhaokham A. The accuracy of single-tooth implants placed using fully digital-guided surgery and freehand implant surgery. J Clin Periodontol. 2019 Sep;46(9):949-957. doi: 10.1111/jcpe.13160. Epub 2019 Jul 19.
- Background: PubMed 36323803Shujaat S, Riaz M, Jacobs R. Synergy between artificial intelligence and precision medicine for computer-assisted oral and maxillofacial surgical planning. Clin Oral Investig. 2023 Mar;27(3):897-906. doi: 10.1007/s00784-022-04706-4. Epub 2022 Nov 3.
- Background: PubMed 37645551Shirmohammadi A, Ghertasi Oskouei S. The growing footprint of artificial intelligence in periodontology & implant dentistry. J Adv Periodontol Implant Dent. 2023 Jun 11;15(1):1-2. doi: 10.34172/japid.2023.012. eCollection 2023. No abstract available.
- Background: PubMed 32777930Murphy DC, Saleh DB. Artificial Intelligence in plastic surgery: What is it? Where are we now? What is on the horizon? Ann R Coll Surg Engl. 2020 Oct;102(8):577-580. doi: 10.1308/rcsann.2020.0158. Epub 2020 Aug 11.
- Background: PubMed 31386555Hung K, Montalvao C, Tanaka R, Kawai T, Bornstein MM. The use and performance of artificial intelligence applications in dental and maxillofacial radiology: A systematic review. Dentomaxillofac Radiol. 2020 Jan;49(1):20190107. doi: 10.1259/dmfr.20190107. Epub 2019 Aug 14.
- Background: PubMed 18672982Ersoy AE, Turkyilmaz I, Ozan O, McGlumphy EA. Reliability of implant placement with stereolithographic surgical guides generated from computed tomography: clinical data from 94 implants. J Periodontol. 2008 Aug;79(8):1339-45. doi: 10.1902/jop.2008.080059.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AI assisted implant placement and Conventional computer guided implant placement in people with Partially Edentulous Mandible, run by Sandra Moussa Botros El Tarzi at 1 site in Egypt.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Apr 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sandra Moussa El Tarzi, BDS (+201226665141, sandra.eltarzi@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear Discrepancy (time frame: Immediate post operative). The study lists 3 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 NCT07523815, which also lists 10 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 13 Apr 2026.