TEETH EXTRACTIONNCT07845019
Guided Root Slice Replantation vs. Socket Shielding for Immediate Implant Placement in Esthetic Zone
A study testing Guided socket shield with immediate implant, Guided Autogenous Root Slicing Replantation with Immediate Implant and Conventional Bone Augmentation with Immediate Implant in people with TEETH EXTRACTION and Esthetic Zone Implantology, run by Minia University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn whether two different tooth-preservation techniques work equally well when placing a dental implant right after a tooth is removed in the front of the mouth (the "esthetic zone"). Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- TEETH EXTRACTION, Esthetic Zone Implantology, Socket Shield Technique Implant Placement
- What is being tested?
- Guided socket shield with immediate implant, Guided Autogenous Root Slicing Replantation with Immediate Implant and Conventional Bone Augmentation with Immediate Implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jun 2026to 30 Mar 2028
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Selected patients of both sexes are 20-40 years old.
- Patients are systemically healthy based on questionnaire dental modification of Cornell index.
- Clinical gingival health either on intact or reduced periodontium according to the new classification system (2017). (Lang, N. P. et al., 2018)
- The recipient site of the implant is free from any active pathological conditions.
- Class II extraction socket according to Sabri and Barootchi classification ( Sabri, H.
- et al., 2024)
- Adequate interocclusal space to accommodate the available restorative components.
- Adequate native/apical bone to achieve primary implant stability.
Who cannot join
- Pregnant female.
- Parafunctional habits such as bruxism and clenching Patients suffering from periodontitis.
- Smokers.
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, Minia University
Minya, Minya Governorate, 61512
Hussein F Hussein, PhD, +201092452350, Hussein.fathy@mu.edu.eg
About this study
Official title: Artificial Intelligence Integrated Planning and Evaluation of Novel Fully Guided Autogenous Root Slice Replantation and Fully Guided Socket Shielding in Immediate Esthetic Implant Placement (Randomized Clinical Trial)
The goal of this clinical trial is to learn whether two different tooth-preservation techniques work equally well when placing a dental implant right after a tooth is removed in the front of the mouth (the "esthetic zone"). It will also learn whether using artificial intelligence (AI) to help plan the surgery improves the results.
The main questions it aims to answer are:
Read more
- Does keeping part of the root in place using a technique called autogenous root slice replantation work as well as a similar technique called socket shielding, in terms of appearance and gum health around the implant?
- Does AI-guided surgical planning improve accuracy, appearance, and gum health compared with traditional planning?
Researchers will compare participants who receive autogenous root slice replantation to participants who receive the socket-shield technique to see if one produces better outcomes than the other. Both groups will have their implants placed using a 3D-printed surgical guide made from AI-assisted digital planning.
Participants will:
- Have a tooth removed and an implant placed on the same day, using one of the two techniques
- Have their surgery guided by a custom surgical guide, planned with AI assistance
- Return for follow-up visits so researchers can check healing, gum appearance, and how well the implant fits with their smile
- Conditions
- TEETH EXTRACTION, Esthetic Zone Implantology, Socket Shield Technique Implant Placement, Root Slicing, Guided Surgery Accuracy
- Being tested
- Guided socket shield with immediate implant, Guided Autogenous Root Slicing Replantation with Immediate Implant, Conventional Bone Augmentation with Immediate Implant, Guided Immediate Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided socket shield with immediate implantProcedure or surgery
A single, AI-planned surgical guide is used to perform both root sectioning and implant osteotomy/placement in one uninterrupted guided sequence. The facial (buccal) portion of the natural root is intentionally retained in situ - decoronated and prepared to a defined sub-crestal height and thickness under full guidance - to preserve the labial bone plate and periodontal ligament-derived vascularity. The implant is placed immediately palatal/lingual to the shield, and immediate provisionalization is performed. This differs from conventional socket-shield protocols, which typically use freehand or dual-guide sequences (separate guides for sectioning and implant placement).
Guided Autogenous Root Slicing Replantation with Immediate ImplantProcedure or surgery
A single, AI-planned surgical guide directs both the harvesting/slicing of an autogenous root segment and the immediate implant osteotomy and placement in one continuous guided workflow. Unlike the socket-shield technique, the root slice is sectioned and then replanted (repositioned) facially within the fresh socket as a free graft, rather than left attached in its native position. The slice is guided to a standardized dimension, position, and depth to support the labial plate and soft tissue architecture. Immediate provisionalization is performed. This is the first reported application of full digital/AI guidance to the ARSR technique.
Conventional Bone Augmentation with Immediate ImplantProcedure or surgery
Immediate implant placement is performed using a single AI-planned surgical guide for implant osteotomy and positioning only (no root-sectioning component). Any labial dehiscence or fenestration defect present after extraction is managed using the current gold-standard approach: particulate bone graft material placed against the defect and covered with a barrier membrane to guide bone regeneration. No tooth root structure is retained. Immediate provisionalization is performed. This arm serves as the active control, isolating the effect of partial extraction therapy (root retention) from AI-guided implant placement alone.
Guided Immediate ImplantProcedure or surgery
Implant placement performed on the same day as tooth extraction, using a single, AI-assisted, fully guided digital surgical protocol common to all three study arms. Pre-operative digital planning (integrating CBCT and intraoral scan data with AI-assisted analysis) is used to determine implant position, angulation, and depth, and to design a single surgical guide. This guide directs the osteotomy and implant insertion, standardizing implant positioning across all arms regardless of the labial defect-management technique used (socket shield, ARSR, or bone augmentation). This shared, standardized component allows the trial to isolate the effect of the labial defect-management technique on esthetic and peri-implant outcomes, since implant placement accuracy is controlled identically across groups.
| Study group | Role | What they receive |
|---|---|---|
| Fully Single Guided Socket Shield | Active comparator | Participants in this arm will undergo the socket-shield technique for immediate implant placement using a single, fully guided digital protocol. Following artificial intelligence (AI)-assisted digital planning, a single surgical guide will direct both the sectioning of the facial root fragment (shield preparation) and the immediate implant osteotomy and placement in one continuous, fully guided sequence. The facial root fragment will be retained to support the labial bone plate and peri-implant soft tissues, while immediate provisionalization will be performed. Participants will be followed to assess implant accuracy, esthetic outcomes, and peri-implant tissue health. Receives: Procedure: Guided socket shield with immediate implant; Procedure: Guided Immediate Implant |
| Fully Guided Autogenous Root Slicing Replantation | Active comparator | Participants in this arm will undergo the autogenous root slice replantation (ARSR) technique for immediate implant placement using a single, fully guided digital protocol. Following artificial intelligence (AI)-assisted digital planning, a single surgical guide will direct both the sectioning and preparation of the autogenous root slice and the immediate implant osteotomy and placement in one continuous, fully guided sequence. The prepared root slice will be replanted and retained facially within the socket to support the labial bone plate and peri-implant soft tissues, while immediate provisionalization will be performed. Participants will be followed to assess implant accuracy, esthetic outcomes, and peri-implant tissue health. Receives: Procedure: Guided Autogenous Root Slicing Replantation with Immediate Implant; Procedure: Guided Immediate Implant |
| Conventional Bone Augmentation | Active comparator | Participants in this arm will undergo immediate implant placement combined with conventional guided bone grafting to manage any labial bone defects (dehiscence or fenestration), rather than a partial extraction therapy technique. Following artificial intelligence (AI)-assisted digital planning, a single surgical guide will direct the immediate implant osteotomy and placement. Bone graft material and a barrier membrane will be used to restore the labial bone defect at the time of implant placement, and immediate provisionalization will be performed. Participants will be followed to assess implant accuracy, esthetic outcomes, and peri-implant tissue health. Receives: Procedure: Conventional Bone Augmentation with Immediate Implant; Procedure: Guided Immediate Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labial Bone Thickness
Labial bone plate thickness measured via cone-beam computed tomography (CBCT) to evaluate preservation of the labial bone contour following autogenous root slice replantation (ARSR), socket shield, or conventional bone augmentation.
Measured: through study completion, an average of 1 year
Marginal Bone Level
Radiographic marginal bone level around the implant, assessed via CBCT, to evaluate crestal bone stability across the three treatment groups.
Measured: through study completion, an average of 1 year
Accuracy of AI-Assisted Digital Planning
AI-based segmentation of the tooth/root to be sectioned will be compared against human (manual) segmentation using a heat map to quantify the average discrepancy between the two, assessing the accuracy and reliability of AI integration in surgical planni
Measured: through study completion, an average of 1 year
Secondary outcomes (9)
Bone Density
Peri-implant bone density assessed labially and proximally via CBCT.
Measured: through study completion, an average of 1 year
Peri-Implant Probing Depth
Clinical probing depth around the implant measured at multiple sites.
Measured: through study completion, an average of 1 year
Modified Gingival Index
Clinical assessment of peri-implant soft tissue inflammation.
Measured: through study completion, an average of 1 year
Modified Plaque Index
Clinical assessment of plaque accumulation around the implant.
Measured: through study completion, an average of 1 year
Keratinized Tissue Width and Thickness
Width and thickness of keratinized mucosa surrounding the implant, measured clinically.
Measured: through study completion, an average of 1 year
Pink Esthetic Score (PES) scaled from 0 to 2
Validated index evaluating the esthetic appearance of the peri-implant soft tissues.
Measured: through study completion, an average of 1 year
White Esthetic Score (WES)
Validated index evaluating the esthetic appearance of the implant-supported crown.
Measured: through study completion, an average of 1 year
Postoperative Pain (Visual Analog Scale)
Patient-reported pain intensity measured using a Visual Analog Scale (VAS).
Measured: through study completion, an average of 1 year
AI Utility in Postoperative Follow-Up
AI-assessed proposed implant fixture position compared against the actual postoperative position, to evaluate the utility and accuracy of AI in follow-up assessment.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start16 Jun 2026
- Primary completionNov 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TEETH EXTRACTIONStudies 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
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Fathy Mohammad Hussein Abo Elkheir, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845019
- Sponsor's protocol ID
- MiniaU128-1322
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alfertshofer M, Gebhart F, Nolte D. Template-Guided Autogenous Tooth Transplantation Using a CAD/CAM Dental Replica in a Complex Anatomical Scenario: A Case Report. Dent J (Basel). 2025 Jun 23;13(7):281. doi: 10.3390/dj13070281.
PubMed 40710126
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Integrated Planning and Evaluation of Novel Fully Guided Autogenous Root Slice Replantation and Fully Guided Socket Shielding in Immediate Esthetic Implant Placement (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07845019
- Acronym / sponsor ID
- MiniaU128-1322
- Conditions
- TEETH EXTRACTION, Esthetic Zone Implantology, Socket Shield Technique Implant Placement, Root Slicing, Guided Surgery Accuracy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 28 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.
The goal of this clinical trial is to learn whether two different tooth-preservation techniques work equally well when placing a dental implant right after a tooth is removed in the front of the mouth (the "esthetic zone"). It will also learn whether using artificial intelligence (AI) to help plan the surgery improves the results.
The main questions it aims to answer are:
- Does keeping part of the root in place using a technique called autogenous root slice replantation work as well as a similar technique called socket shielding, in terms of appearance and gum health around the implant?
- Does AI-guided surgical planning improve accuracy, appearance, and gum health compared with traditional planning?
Researchers will compare participants who receive autogenous root slice replantation to participants who receive the socket-shield technique to see if one produces better outcomes than the other. Both groups will have their implants placed using a 3D-printed surgical guide made from AI-assisted digital planning.
Participants will:
- Have a tooth removed and an implant placed on the same day, using one of the two techniques
- Have their surgery guided by a custom surgical guide, planned with AI assistance
- Return for follow-up visits so researchers can check healing, gum appearance, and how well the implant fits with their smile
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fully Single Guided Socket Shield | Active comparator | Procedure: Guided socket shield with immediate implant, Procedure: Guided Immediate ImplantParticipants in this arm will undergo the socket-shield technique for immediate implant placement using a single, fully guided digital protocol. Following artificial intelligence (AI)-assisted digital planning, a single surgical guide will direct both the sectioning of the facial root fragment (shield preparation) and the immediate implant osteotomy and placement in one continuous, fully guided sequence. The facial root fragment will be retained to support the labial bone plate and peri-implant soft tissues, while immediate provisionalization will be performed. Participants will be followed to assess implant accuracy, esthetic outcomes, and peri-implant tissue health. |
| Fully Guided Autogenous Root Slicing Replantation | Active comparator | Procedure: Guided Autogenous Root Slicing Replantation with Immediate Implant, Procedure: Guided Immediate ImplantParticipants in this arm will undergo the autogenous root slice replantation (ARSR) technique for immediate implant placement using a single, fully guided digital protocol. Following artificial intelligence (AI)-assisted digital planning, a single surgical guide will direct both the sectioning and preparation of the autogenous root slice and the immediate implant osteotomy and placement in one continuous, fully guided sequence. The prepared root slice will be replanted and retained facially within the socket to support the labial bone plate and peri-implant soft tissues, while immediate provisionalization will be performed. Participants will be followed to assess implant accuracy, esthetic outcomes, and peri-implant tissue health. |
| Conventional Bone Augmentation | Active comparator | Procedure: Conventional Bone Augmentation with Immediate Implant, Procedure: Guided Immediate ImplantParticipants in this arm will undergo immediate implant placement combined with conventional guided bone grafting to manage any labial bone defects (dehiscence or fenestration), rather than a partial extraction therapy technique. Following artificial intelligence (AI)-assisted digital planning, a single surgical guide will direct the immediate implant osteotomy and placement. Bone graft material and a barrier membrane will be used to restore the labial bone defect at the time of implant placement, and immediate provisionalization will be performed. Participants will be followed to assess implant accuracy, esthetic outcomes, and peri-implant tissue health. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Selected patients of both sexes are 20-40 years old.
- Patients are systemically healthy based on questionnaire dental modification of Cornell index.
- Clinical gingival health either on intact or reduced periodontium according to the new classification system (2017). (Lang, N. P. et al., 2018)
- The recipient site of the implant is free from any active pathological conditions.
- Class II extraction socket according to Sabri and Barootchi classification ( Sabri, H.
Key exclusion criteria (3 listed)
- Pregnant female.
- Parafunctional habits such as bruxism and clenching Patients suffering from periodontitis.
- Smokers.
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 |
|---|---|---|
| Guided socket shield with immediate implantA single, AI-planned surgical guide is used to perform both root sectioning and implant osteotomy/placement in one uninterrupted guided sequence. The facial (buccal) portion of the natural root is intentionally retained in situ - decoronated and prepared to a defined sub-crestal height and thickness under full guidance - to preserve the labial bone plate and periodontal ligament-derived vascularity. The implant is placed immediately palatal/lingual to the shield, and immediate provisionalization is performed. This differs from conventional socket-shield protocols, which typically use freehand or dual-guide sequences (separate guides for sectioning and implant placement). | Procedure or surgery | Fully Single Guided Socket Shield |
| Guided Autogenous Root Slicing Replantation with Immediate ImplantA single, AI-planned surgical guide directs both the harvesting/slicing of an autogenous root segment and the immediate implant osteotomy and placement in one continuous guided workflow. Unlike the socket-shield technique, the root slice is sectioned and then replanted (repositioned) facially within the fresh socket as a free graft, rather than left attached in its native position. The slice is guided to a standardized dimension, position, and depth to support the labial plate and soft tissue architecture. Immediate provisionalization is performed. This is the first reported application of full digital/AI guidance to the ARSR technique. | Procedure or surgery | Fully Guided Autogenous Root Slicing Replantation |
| Conventional Bone Augmentation with Immediate ImplantImmediate implant placement is performed using a single AI-planned surgical guide for implant osteotomy and positioning only (no root-sectioning component). Any labial dehiscence or fenestration defect present after extraction is managed using the current gold-standard approach: particulate bone graft material placed against the defect and covered with a barrier membrane to guide bone regeneration. No tooth root structure is retained. Immediate provisionalization is performed. This arm serves as the active control, isolating the effect of partial extraction therapy (root retention) from AI-guided implant placement alone. | Procedure or surgery | Conventional Bone Augmentation |
| Guided Immediate ImplantImplant placement performed on the same day as tooth extraction, using a single, AI-assisted, fully guided digital surgical protocol common to all three study arms. Pre-operative digital planning (integrating CBCT and intraoral scan data with AI-assisted analysis) is used to determine implant position, angulation, and depth, and to design a single surgical guide. This guide directs the osteotomy and implant insertion, standardizing implant positioning across all arms regardless of the labial defect-management technique used (socket shield, ARSR, or bone augmentation). This shared, standardized component allows the trial to isolate the effect of the labial defect-management technique on esthetic and peri-implant outcomes, since implant placement accuracy is controlled identically across groups. | Procedure or surgery | Conventional Bone Augmentation, Fully Guided Autogenous Root Slicing Replantation, Fully Single Guided Socket Shield |
Primary outcome
Labial Bone Thickness
Time frame: through study completion, an average of 1 year
Labial bone plate thickness measured via cone-beam computed tomography (CBCT) to evaluate preservation of the labial bone contour following autogenous root slice replantation (ARSR), socket shield, or conventional bone augmentation.
Marginal Bone Level
Time frame: through study completion, an average of 1 year
Radiographic marginal bone level around the implant, assessed via CBCT, to evaluate crestal bone stability across the three treatment groups.
Accuracy of AI-Assisted Digital Planning
Time frame: through study completion, an average of 1 year
AI-based segmentation of the tooth/root to be sectioned will be compared against human (manual) segmentation using a heat map to quantify the average discrepancy between the two, assessing the accuracy and reliability of AI integration in surgical planni
9 secondary outcomes
Bone Density
Time frame: through study completion, an average of 1 year
Peri-Implant Probing Depth
Time frame: through study completion, an average of 1 year
Modified Gingival Index
Time frame: through study completion, an average of 1 year
Modified Plaque Index
Time frame: through study completion, an average of 1 year
Keratinized Tissue Width and Thickness
Time frame: through study completion, an average of 1 year
Pink Esthetic Score (PES) scaled from 0 to 2
Time frame: through study completion, an average of 1 year
White Esthetic Score (WES)
Time frame: through study completion, an average of 1 year
Postoperative Pain (Visual Analog Scale)
Time frame: through study completion, an average of 1 year
AI Utility in Postoperative Follow-Up
Time frame: through study completion, an average of 1 year
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 28 Sep 2026.
- Background: PubMed 40710126Alfertshofer M, Gebhart F, Nolte D. Template-Guided Autogenous Tooth Transplantation Using a CAD/CAM Dental Replica in a Complex Anatomical Scenario: A Case Report. Dent J (Basel). 2025 Jun 23;13(7):281. doi: 10.3390/dj13070281.
- 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 study testing Guided socket shield with immediate implant, Guided Autogenous Root Slicing Replantation with Immediate Implant and Conventional Bone Augmentation with Immediate Implant in people with TEETH EXTRACTION and Esthetic Zone Implantology, run by Minia 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 8 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: looking for participants now, as of the sponsor's last update on 28 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 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?
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 Hussein F Hussein, PhD (+201092452350, hussein.fathy@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labial Bone Thickness (time frame: through study completion, an average of 1 year). 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 NCT07845019, which also lists 1 linked publication.
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 28 Sep 2026.