Partial Edentulism Class 1 or Class 2NCT07891442
Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
A study testing Dental implant palcement in people with Partial Edentulism Class 1 or Class 2, run by Mariam Morcos Nasr.
Trial summary
This study aims to compare the accuracy and clinical performance of artificial intelligence (AI)-assisted implant planning with conventional human-based implant planning in patients presenting with free-end saddle edentulous areas requiring dental implant rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Edentulism Class 1 or Class 2
- What is being tested?
- Dental implant palcement
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2026to Nov 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Adult patients aged 18 years or older. 2) Patients with unilateral or bilateral posterior edentulous spaces (free-end saddle cases) requiring implant therapy.
- 3) Patients with adequate bone volume for implant placement as determined by CBCT examination.
- 4) Medically fit patients eligible for implant surgery. 5) Patient compliance and positive attitude towards oral hygiene.
Who cannot join
- 1) Patients younger than 18 years. 2) Patients with systemic conditions that may compromise osseointegration or bone healing (e.g., uncontrolled diabetes mellitus, recent radiotherapy to the jaws, severe osteoporosis, history of bisphosphonate therapy).
- 3) Pregnant women. 4) noncompliance Patients or patients with poor oral hygiene.
About this study
This study aims to compare the accuracy and clinical performance of artificial intelligence (AI)-assisted implant planning with conventional human-based implant planning in patients presenting with free-end saddle edentulous areas requiring dental implant rehabilitation. Preoperative cone-beam computed tomography (CBCT) images and intraoral scans will be used to assess the available bone, anatomical landmarks, and prosthetically driven implant positions. Implant planning and surgical guide fabrication will be performed using standardized digital workflows under the supervision of an experienced implant planning specialist. Postoperative CBCT imaging will be used to evaluate deviations between the planned and actual implant positions. The study will assess the accuracy of both planning approaches to determine whether AI-assisted planning provides comparable or improved implant placement accuracy relative to conventional planning.
Read the detailed description
This study aims to compare the accuracy and clinical performance of artificial intelligence (AI)-assisted implant planning with conventional human-based implant planning in patients presenting with free-end saddle edentulous areas requiring dental implant rehabilitation. Participants will be allocated into two groups. The first group will serve as the control group and will undergo conventional implant planning performed by an experienced implant planning specialist using standard digital planning protocols. The second group will serve as the test group and will undergo AI-assisted implant planning, with the proposed implant positions reviewed and, when necessary, adjusted by the same experienced specialist to ensure clinical safety and prosthetically driven treatment planning.
For both groups, preoperative cone-beam computed tomography (CBCT) images and intraoral scans will be obtained and digitally merged to evaluate the available bone volume, bone density, anatomical landmarks, prosthetic requirements, and the relationship between the planned implant position and the final restoration. In the control group, implant position, angulation, depth, and restorative emergence profile will be determined using conventional clinician-based planning. In the test group, these parameters will initially be generated using an artificial intelligence-assisted planning system based on the same clinical and radiographic data. Then it will be reviewed, evaluated and adjusted by specialist. Surgical guides will then be designed and fabricated for both groups using standardized digital workflows.
All participants will undergo implant placement according to the approved treatment plan and surgical guide. The same surgical and restorative protocols will be followed for both groups to minimize the influence of factors unrelated to the planning method. Postoperative CBCT imaging will be obtained after implant placement and superimposed on the preoperative planning data. The accuracy of implant placement will be evaluated by measuring 3D deviation of the implant platform, apex, and angle between the planned and placed positions.
Secondary clinical outcomes may include the time required for treatment planning, the number of modifications made to the initial plan, surgical guide fit and stability, intraoperative complications, and the clinician's assessment of the usability of each planning method. The results obtained from the control and test groups will be statistically compared to determine whether AI-assisted implant planning provides implant placement accuracy that is comparable to or better than conventional clinician-based planning in free-end saddle cases. This comparison will also help assess whether AI-assisted planning can improve workflow efficiency while maintaining clinical safety and prosthetically appropriate implant positioning.
- Conditions
- Partial Edentulism Class 1 or Class 2
- Being tested
- Dental implant palcement
- Keywords
- Dental implant - Surgical guide - Artificial Intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant palcementProcedure or surgery
- All surgical procedures will be performed by the same operator. Prior to surgery patient will be instructed to rinse with 0.1% chlorhexidine gluconate for 30 seconds.
- Anesthesia will be obtained by administration of 2% lidocaine 1:80,000 epinephrine.
- In both study groups, the surgical guides will be clinically evaluated prior to surgery to ensure accurate fit, complete seating, and adequate stability on the supporting oral structures.
- After confirmation of proper guide fit and stability, implant osteotomies will be performed through the surgical guide following the manufacturer's prescribed drilling sequence. Subsequently, the implants will be inserted according to the manufacturer's recommended surgical protocol.
- Final insertion of crowns will be done after 4-6 months.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: control group | Sham comparator | patients in this arm will receive implant therapy using conventionally planned, human-assisted surgical guide. Receives: Procedure: Dental implant palcement |
| Arm 2: test group | Active comparator | patients in this arm will receive implant therapy using a surgical guide produced through an AI-assisted implant planning workflow. The AI-generated treatment plan and surgical guide design will be reviewed, verified, and approved prior to guide fabrication and surgical implementation. Receives: Procedure: Dental implant palcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D deviation.
By using surface-based registration, the postoperative CBCT will be super imposed onto the preoperative CBCT, which contains the virtual implant planned position. One operator will conduct all measurements by means of the treatment evaluation module of the software, calculating the 3D deviation of the implant platform, apex, and angle between the planned and placed positions.
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 posted23 Oct 2026
- Study start25 Oct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Edentulism Class 1 or Class 2Studies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mariam Morcos Nasr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mariam Morcos Nasr, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891442
- Sponsor's protocol ID
- 4646
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
- ClinicalTrials.gov ID
- NCT07891442
- Acronym / sponsor ID
- 4646
- Conditions
- Partial Edentulism Class 1 or Class 2
- Keywords
- Dental implant - Surgical guide - Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mariam Morcos NasrUniversity, hospital or other
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Oct 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 compare the accuracy and clinical performance of artificial intelligence (AI)-assisted implant planning with conventional human-based implant planning in patients presenting with free-end saddle edentulous areas requiring dental implant rehabilitation. Preoperative cone-beam computed tomography (CBCT) images and intraoral scans will be used to assess the available bone, anatomical landmarks, and prosthetically driven implant positions. Implant planning and surgical guide fabrication will be performed using standardized digital workflows under the supervision of an experienced implant planning specialist. Postoperative CBCT imaging will be used to evaluate deviations between the planned and actual implant positions. The study will assess the accuracy of both planning approaches to determine whether AI-assisted planning provides comparable or improved implant placement accuracy relative to conventional planning.
Detailed description
This study aims to compare the accuracy and clinical performance of artificial intelligence (AI)-assisted implant planning with conventional human-based implant planning in patients presenting with free-end saddle edentulous areas requiring dental implant rehabilitation. Participants will be allocated into two groups. The first group will serve as the control group and will undergo conventional implant planning performed by an experienced implant planning specialist using standard digital planning protocols. The second group will serve as the test group and will undergo AI-assisted implant planning, with the proposed implant positions reviewed and, when necessary, adjusted by the same experienced specialist to ensure clinical safety and prosthetically driven treatment planning.
For both groups, preoperative cone-beam computed tomography (CBCT) images and intraoral scans will be obtained and digitally merged to evaluate the available bone volume, bone density, anatomical landmarks, prosthetic requirements, and the relationship between the planned implant position and the final restoration. In the control group, implant position, angulation, depth, and restorative emergence profile will be determined using conventional clinician-based planning. In the test group, these parameters will initially be generated using an artificial intelligence-assisted planning system based on the same clinical and radiographic data. Then it will be reviewed, evaluated and adjusted by specialist. Surgical guides will then be designed and fabricated for both groups using standardized digital workflows.
All participants will undergo implant placement according to the approved treatment plan and surgical guide. The same surgical and restorative protocols will be followed for both groups to minimize the influence of factors unrelated to the planning method. Postoperative CBCT imaging will be obtained after implant placement and superimposed on the preoperative planning data. The accuracy of implant placement will be evaluated by measuring 3D deviation of the implant platform, apex, and angle between the planned and placed positions.
Secondary clinical outcomes may include the time required for treatment planning, the number of modifications made to the initial plan, surgical guide fit and stability, intraoperative complications, and the clinician's assessment of the usability of each planning method. The results obtained from the control and test groups will be statistically compared to determine whether AI-assisted implant planning provides implant placement accuracy that is comparable to or better than conventional clinician-based planning in free-end saddle cases. This comparison will also help assess whether AI-assisted planning can improve workflow efficiency while maintaining clinical safety and prosthetically appropriate implant positioning.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: control group | Sham comparator | Procedure: Dental implant palcementpatients in this arm will receive implant therapy using conventionally planned, human-assisted surgical guide. |
| Arm 2: test group | Active comparator | Procedure: Dental implant palcementpatients in this arm will receive implant therapy using a surgical guide produced through an AI-assisted implant planning workflow. The AI-generated treatment plan and surgical guide design will be reviewed, verified, and approved prior to guide fabrication and surgical implementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1) Adult patients aged 18 years or older. 2) Patients with unilateral or bilateral posterior edentulous spaces (free-end saddle cases) requiring implant therapy.
- 3) Patients with adequate bone volume for implant placement as determined by CBCT examination.
- 4) Medically fit patients eligible for implant surgery. 5) Patient compliance and positive attitude towards oral hygiene.
Key exclusion criteria (2 listed)
- 1) Patients younger than 18 years. 2) Patients with systemic conditions that may compromise osseointegration or bone healing (e.g., uncontrolled diabetes mellitus, recent radiotherapy to the jaws, severe osteoporosis, history of bisphosphonate therapy).
- 3) Pregnant women. 4) noncompliance Patients or patients with poor oral hygiene.
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 |
|---|---|---|
| Dental implant palcement* All surgical procedures will be performed by the same operator. Prior to surgery patient will be instructed to rinse with 0.1% chlorhexidine gluconate for 30 seconds. * Anesthesia will be obtained by administration of 2% lidocaine 1:80,000 epinephrine. * In both study groups, the surgical guides will be clinically evaluated prior to surgery to ensure accurate fit, complete seating, and adequate stability on the supporting oral structures. * After confirmation of proper guide fit and stability, implant osteotomies will be performed through the surgical guide following the manufacturer's prescribed drilling sequence. Subsequently, the implants will be inserted according to the manufacturer's recommended surgical protocol. * Final insertion of crowns will be done after 4-6 months. | Procedure or surgery | Arm 1: control group, Arm 2: test group |
Primary outcome
3D deviation.
Time frame: 1 month
By using surface-based registration, the postoperative CBCT will be super imposed onto the preoperative CBCT, which contains the virtual implant planned position. One operator will conduct all measurements by means of the treatment evaluation module of the software, calculating the 3D deviation of the implant platform, apex, and angle between the planned and placed positions.
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 23 Oct 2026.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implant palcement in people with Partial Edentulism Class 1 or Class 2, run by Mariam Morcos Nasr.
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 2 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D deviation. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2026.