Implant ComplicationNCT06299449
Artificial Intelligence Assisted Socket Shield With Computer Guided Implant Placement
A study testing free-hand socket shield and AI/guided socket shield in people with Implant Complication and Dental Implant Failed, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided immediate implant placement performed simultaneously with artificial intelligence assisted socket shield technique versus conventional approach. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Complication, Dental Implant Failed
- What is being tested?
- free-hand socket shield and AI/guided socket shield
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Mar 2024to 6 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- above the age of 18years
- presence of non-restorable maxillary anterior tooth
- had intact socket walls following tooth extraction
- the gingival biotype was thick.
Who cannot join
- history of systemic condition
- history of using bisphosphonates or other drugs that might impact bone turnover
- a history of smoking during the previous five years,
- a history of any acute infections at the surgical site,
- teeth having root resorptions
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry, kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 214312
About this study
Official title: Clinical and Radiographic Outcomes of Computer Guided Immediate Implant Placement Utilizing Artificial Intelligence Assisted Socket Shield Approach: Randomized Clinical Trial
Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided immediate implant placement performed simultaneously with artificial intelligence assisted socket shield technique versus conventional approach.
Read the detailed description
Guided implant surgery was used in dental implant surgery to achieve accuracy and an overall predictability. Successful guided implant workflow depends on 3-dimensional image acquisition and precise model fabrication.
Artificial intelligence application in implant dentistry has ushered in a new era of precision and efficiency demonstrating improved implant survival rates and patient satisfaction and enhance the integration of technologies with digital workflows.
- Conditions
- Implant Complication, Dental Implant Failed
- Being tested
- free-hand socket shield, AI/guided socket shield
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free-hand socket shieldProcedure or surgery
Also called Elamrousy Novel Approach of Socket Shield Technique
Immediate Implant Placement Using Socket Shield Technique with autogenous whole tooth graft after immediate implantation using Socket Shield Technique, the palatal root portion and the decoronated crown will be converted to autogenous whole tooth graft and used for grafting the defect between the socket shield and the implant fixture
AI/guided socket shieldProcedure or surgery
Also called AI/guided Elamrousy Novel Approach of Socket Shield Technique
The patient specific guides will be placed at the pre-planned positions at the labial buccal mucosa.
using artificial intelligence the socket shield approach will be planned to keep the buccal shield and using surgical guide the shield will be preciesly prepared followed by guided implant placement and whole tooth grafting of the jumping gap
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | conventional socket shield with conventional simultaneous implant placement Receives: Procedure: free-hand socket shield |
| study group | Experimental | computer guided implant placement combined with artificial intelligence-assisted socket shield. Receives: Procedure: AI/guided socket shield |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability Quotient of dental implant
Osstell TM was used to record the primary stability.ISQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. The ISQ scale has a non-linear correlation to micro mobility. With more than 1400 scientific references, investigators now know that high stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability
Measured: 24-month.
pink esthetic score
The pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency.Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14
Measured: 24-month.
Midfacial Mucosal Alterations
digital intraoral scans were recorded. To quantify the vertical changes in the soft tissues around implants buccally, the collected scans were digitally superimposed via matching Gom inspect software
Measured: 24-month.
facial marginal bone level
Utilizing CBCT sagittal sections, the BMBL was evaluated by computerized analysis. Navigation was done on the multiplanar display until the implant's precise same-view location was established on the reformatted cross-sectional section and panoramic view.
Measured: 24-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start5 Mar 2024
- Primary completion17 Apr 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant ComplicationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Elamrousy, Kafrelsheikh University
- Investigators
- Walid AH Elamrousy, PhD, Study director, Faculty of Oral and Dental Medicine, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299449
- Sponsor's protocol ID
- KFSIRB200-174
- Status last verified
- May 2026
- First submitted
- 1 Mar 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the new approach of using artificial intelligence to assist in the planning of socket shield technique will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of Computer Guided Immediate Implant Placement Utilizing Artificial Intelligence Assisted Socket Shield Approach: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06299449
- Acronym / sponsor ID
- KFSIRB200-174
- Conditions
- Implant Complication, Dental Implant Failed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 7 Mar 2024 (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.
Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided immediate implant placement performed simultaneously with artificial intelligence assisted socket shield technique versus conventional approach.
Detailed description
Guided implant surgery was used in dental implant surgery to achieve accuracy and an overall predictability. Successful guided implant workflow depends on 3-dimensional image acquisition and precise model fabrication.
Artificial intelligence application in implant dentistry has ushered in a new era of precision and efficiency demonstrating improved implant survival rates and patient satisfaction and enhance the integration of technologies with digital workflows.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Procedure: free-hand socket shieldconventional socket shield with conventional simultaneous implant placement |
| study group | Experimental | Procedure: AI/guided socket shieldcomputer guided implant placement combined with artificial intelligence-assisted socket shield. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- above the age of 18years
- presence of non-restorable maxillary anterior tooth
- had intact socket walls following tooth extraction
- the gingival biotype was thick.
Key exclusion criteria (5 listed)
- history of systemic condition
- history of using bisphosphonates or other drugs that might impact bone turnover
- a history of smoking during the previous five years,
- a history of any acute infections at the surgical site,
- teeth having root resorptions
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 |
|---|---|---|
| free-hand socket shieldAlso: Elamrousy Novel Approach of Socket Shield TechniqueImmediate Implant Placement Using Socket Shield Technique with autogenous whole tooth graft after immediate implantation using Socket Shield Technique, the palatal root portion and the decoronated crown will be converted to autogenous whole tooth graft and used for grafting the defect between the socket shield and the implant fixture | Procedure or surgery | control group |
| AI/guided socket shieldAlso: AI/guided Elamrousy Novel Approach of Socket Shield TechniqueThe patient specific guides will be placed at the pre-planned positions at the labial buccal mucosa. using artificial intelligence the socket shield approach will be planned to keep the buccal shield and using surgical guide the shield will be preciesly prepared followed by guided implant placement and whole tooth grafting of the jumping gap | Procedure or surgery | study group |
Primary outcome
Stability Quotient of dental implant
Time frame: 24-month.
Osstell TM was used to record the primary stability.ISQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. The ISQ scale has a non-linear correlation to micro mobility. With more than 1400 scientific references, investigators now know that high stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability
pink esthetic score
Time frame: 24-month.
The pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency.Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14
Midfacial Mucosal Alterations
Time frame: 24-month.
digital intraoral scans were recorded. To quantify the vertical changes in the soft tissues around implants buccally, the collected scans were digitally superimposed via matching Gom inspect software
facial marginal bone level
Time frame: 24-month
Utilizing CBCT sagittal sections, the BMBL was evaluated by computerized analysis. Navigation was done on the multiplanar display until the implant's precise same-view location was established on the reformatted cross-sectional section and panoramic view.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. the new approach of using artificial intelligence to assist in the planning of socket shield technique will not be shared
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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. This study is not recruiting at the moment.
Walid AH Elamrousy, PhD study director
Faculty of Oral and Dental Medicine, Kafrelsheikh 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 free-hand socket shield and AI/guided socket shield in people with Implant Complication and Dental Implant Failed, run by Kafrelsheikh University 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 5 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: finished, as of the sponsor's last update on 13 May 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stability Quotient of dental implant (time frame: 24-month.). The study lists 4 primary outcomes in all. 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 13 May 2026.