Dental Implant FailedNCT07433920
L-PRF Versus Sticky Bone Grafting of the Jumping Gap in AI-assisted Computer-Guided Socket Shield Immediate Implantation
A study testing Socket shield with PRF, Sticky tooth group and Sticky bonegroup in people with Dental Implant Failed, run by Kafrelsheikh University at 2 sites in Egypt.
Trial summary
the rationale of the current study is to address a focused and clinically relevant gap in socket shield therapy: which biologic modality best supports healing of the shield-implant gap when SST is performed under a standardized, digitally guided workflow. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- Socket shield with PRF, Sticky tooth group and Sticky bonegroup
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesEgypt
- Study dates
- 23 Feb 2026to 28 Mar 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically healthy patients according to the American Society of Anesthesiologists (ASA) physical status classification system; only patients belonging to ASA I and ASA II categories will be included in this study.
- Age > 18 years.
- Patients presenting with one non-restorable hopeless anterior tooth due to extensive caries, cervical/root fracture, vertical or oblique root fracture, multiple failed endodontic treatments, or root resorption.
- Sufficient apical/palatal bone to obtain primary implant stability.
Who cannot join
- Patients belonging to ASA III, ASA IV and ASA V will be excluded.
- Vertical root fracture involving the labial aspect of the root planned to be retained as the facial shield.
- Horizontal root fracture that is too far apically located.
- Presence of acute (active) periapical infection.
- Large chronic periapical lesion.
- Lack of sufficient bone apical to the extraction socket to obtain primary stability. * Ankylosed tooth positioned too apically in relation to adjacent teeth.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nour Hatata, Phd contact
Egypt2 sites, 2 recruiting
- Recruiting
faculty of dentistry, kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 214312
walid elamrousy, +201005724781, Waled_Hammed@den.kfs.edu.eg
- Recruiting
Walid Elamrousy
Kafr ash Shaykh, 76130
walid elamrousy, phd, +201005724781, Waled_Hammed@den.kfs.edu.eg
mostafa fayed, bachelor, +201063376252
About this study
Official title: L-PRF Versus Sticky Bone Grafting of the Jumping Gap in AI-assisted/Computer-Guided Socket Shield Immediate Dental Implantation: A Randomized Clinical Trial
the rationale of the current study is to address a focused and clinically relevant gap in socket shield therapy: which biologic modality best supports healing of the shield-implant gap when SST is performed under a standardized, digitally guided workflow. The study will compare three shield-implant gap filling modalities: (i) L-PRF alone (without membrane), (ii) sticky tooth (autogenous dentin graft +i- PRF), and (iii) sticky bone (particulate graft + i- PRF) under AI-assisted, patient-specific guided implant placement based on IOS/CBCT superimposition, with CBCT follow-up at immediate, 3 months, and 6 months. The working hypothesis is that biologically active, cohesive composites (sticky tooth and sticky bone) will provide superior hard- and soft-tissue dimensional stability compared with PRF alone by improving space maintenance and early wound stability in the shield-implant gap . The null hypothesis is that there will be no statistically significant differences between the three modalities in radiographic and digitally assessed clinical outcomes over the 6-month follow-up period .
Read the detailed description
The socket shield technique (SST), a form of partial extraction therapy, was introduced to address the facial-bundle-bone problem by intentionally retaining a buccal root fragment with its periodontal ligament to help maintain blood supply and support the facial plate.
Among biologic options for filling peri-implant gaps, platelet-rich fibrin (PRF) is attractive because it is autologous, inexpensive, and provides a fibrin scaffold with a sustained release of growth factors that may support angiogenesis and early tissue maturation. At the cellular and molecular level, De Bruyn et al. (2024) demonstrated that leukocyte- and platelet-rich fibrin contains a complex cellular ecosystem and growth factor kinetics that can plausibly support regenerative wound healing, strengthening the biologic rationale for using L-PRF in challenging healing environment. A recent systematic review in Minerva Dental and Oral Science (2024/2025) also concluded that PRF may aid peri implant gap fill and soft-tissue healing in immediate implant contexts, but called for better standardized trials and clearer indications.
Beyond PRF alone, two "composite" concepts have gained attention: sticky tooth and sticky bone. Sticky tooth generally refers to autogenous tooth-derived dentin granules combined with platelet concentrates to create a cohesive graft, leveraging dentin's mineral and collagen composition and its proposed bioactivity. In a histologic evaluation, van Orten et al. (2022) described tooth-derived granules mixed with PRF ("sticky tooth") as a feasible socket preservation approach with histologic evidence of graft integration patterns consistent with bone remodeling, supporting its potential as an autogenous biomaterial with low immunologic risk. Separately, tooth-derived grafts have been increasingly investigated as alternatives to xenografts/allografts, yet protocols vary widely in processing, particle size, sterilization, and mixing with blood products-creating a knowledge gap regarding standardization and reproducibility across centers.
Sticky bone most commonly refers to particulate bone substitute (often xenograft or allograft) combined with injectable PRF (i-PRF) to form a moldable, fibrin-rich mass intended to improve handling, stabilize particles, and potentially enhance early biologic activity. In a randomized parallel-arm clinical trial, Tony et al. (2022) assessed sticky bone for horizontal ridge augmentation using CBCT outcomes, supporting that i-PRF-based composites can be evaluated quantitatively and may influence hard-tissue results depending on adjunctive membrane use.
Collectively, these findings suggest a strong rationale to test whether sticky tooth and sticky bone can serve as optimized fillers for the shield-implant gap in SST-where space maintenance, clot stability, and early vascularization may be decisive.
High-quality assessment of subtle contour changes requires accurate, reproducible measurement methods. Contemporary digital workflows combine CBCT with intraoral scanning (IOS) to enable three-dimensional planning, guided surgery, and longitudinal volumetric evaluation. A key technical step is accurate CBCT-IOS registration and superimposition. In a systematic review and meta-analysis, Zheng et al. (2025) concluded that automatic multimodal registration methods-particularly those incorporating AI-have improved efficiency and robustness, but performance can still be affected by landmark instability, artifact burden, and dataset diversity, indicating a need for clinically validated workflows in implant planning and follow-up. Similarly, Flügge et al. (2017) demonstrated that digital model registration accuracy is clinically relevant and must be managed carefully to avoid propagating errors into guided surgery and outcome assessment, supporting strict standardization in trials that use superimposition as a primary endpoint. Within SST specifically, Zhang et al. (2020) introduced the clinical concept of guided residual root preparation to reduce technique sensitivity and improve repeatability of shield preparation, indicating that guided approaches may address one of SST's main drawbacks-operator variability.
Artificial intelligence is increasingly integrated into implant dentistry, particularly in image segmentation, automated registration, planning support, and outcome prediction. Altalhi et al. (2023) summarized current and emerging AI applications in implantology, including planning precision and the movement toward more automated, data-driven workflows, while also cautioning that validation and transparency are essential before widespread clinical dependence. In a foundational perspective, Schwendicke et al. (2020) argued that AI in dentistry offers clear opportunities in decision support and automation, but requires high-quality training data, rigorous evaluation, and careful governance to ensure safe clinical translation . In the context of the present work, AI-assisted planning after IOS superimposition could strengthen the standardization of implant positioning and patient-specific guide fabrication, thereby reducing confounding variability and allowing a clearer comparison of biologic gap-filling materials
- Conditions
- Dental Implant Failed
- Being tested
- Socket shield with PRF, Sticky tooth group, Sticky bonegroup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket shield with PRFProcedure or surgery
shield/implant gap will be grafted by PRF alone
Sticky tooth groupProcedure or surgery
shield/implant gap will be grafted by sticky tooth graft
Sticky bonegroupProcedure or surgery
shield/implant gap will be grafted by sticky xenograft
| Study group | Role | What they receive |
|---|---|---|
| PRF alone group | Active comparator | Immediately after implant placement, leukocyte-platelet rich fibrin (L-PRF) will be prepared, then gently packed into the implant-shield gap Receives: Procedure: Socket shield with PRF |
| Sticky tooth group | Experimental | The extracted palatal root portion will be cleaned and processed chairside into dentin particles, then mixed with PRF clot to form "sticky tooth" that will be packed into the implant-shield gap Receives: Procedure: Sticky tooth group |
| Sticky bone group | Experimental | xenograft will be mixed with PRF clot to form "sticky bone" that will be packed into the implant-shield gap Receives: Procedure: Sticky bonegroup |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal bone level
marginal bone level (FMBL) will be recorded as the vertical distance (mm) from the implant shoulder (or implant platform reference) to the most coronal point of the facial bone crest on the midfacial aspect
Measured: 12 months
Secondary outcomes (1)
Peri-implant vertical bone defect depth
Peri-implant vertical bone defect depth will be measured mesially and distally as the vertical distance from a horizontal reference line at the implant shoulder to the first bone-to implant contact on each side, then averaged per implant for analysis. The use of CBCT for quantifying peri-implant defects and marginal bone morphology is supported by evidence showing superior defect detection and measurement capability compared with intraoral imaging, while emphasizing standardized acquisition and awareness of artifacts
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start23 Feb 2026
- Primary completion3 Mar 2027 (estimated)
- Study completion28 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Model description
- grafting the shield/fixture gap with leukocyte-platelet rich fibrin (L-PRF)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Elamrousy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433920
- Sponsor's protocol ID
- KFSIRB200-925
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-PRF Versus Sticky Bone Grafting of the Jumping Gap in AI-assisted/Computer-Guided Socket Shield Immediate Dental Implantation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07433920
- Acronym / sponsor ID
- KFSIRB200-925
- Conditions
- Dental Implant Failed
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 3 Mar 2027 (estimated)
- Study completion
- 28 Mar 2027 (estimated)
- First posted
- 25 Feb 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 rationale of the current study is to address a focused and clinically relevant gap in socket shield therapy: which biologic modality best supports healing of the shield-implant gap when SST is performed under a standardized, digitally guided workflow. The study will compare three shield-implant gap filling modalities: (i) L-PRF alone (without membrane), (ii) sticky tooth (autogenous dentin graft +i- PRF), and (iii) sticky bone (particulate graft + i- PRF) under AI-assisted, patient-specific guided implant placement based on IOS/CBCT superimposition, with CBCT follow-up at immediate, 3 months, and 6 months. The working hypothesis is that biologically active, cohesive composites (sticky tooth and sticky bone) will provide superior hard- and soft-tissue dimensional stability compared with PRF alone by improving space maintenance and early wound stability in the shield-implant gap . The null hypothesis is that there will be no statistically significant differences between the three modalities in radiographic and digitally assessed clinical outcomes over the 6-month follow-up period .
Detailed description
The socket shield technique (SST), a form of partial extraction therapy, was introduced to address the facial-bundle-bone problem by intentionally retaining a buccal root fragment with its periodontal ligament to help maintain blood supply and support the facial plate.
Among biologic options for filling peri-implant gaps, platelet-rich fibrin (PRF) is attractive because it is autologous, inexpensive, and provides a fibrin scaffold with a sustained release of growth factors that may support angiogenesis and early tissue maturation. At the cellular and molecular level, De Bruyn et al. (2024) demonstrated that leukocyte- and platelet-rich fibrin contains a complex cellular ecosystem and growth factor kinetics that can plausibly support regenerative wound healing, strengthening the biologic rationale for using L-PRF in challenging healing environment. A recent systematic review in Minerva Dental and Oral Science (2024/2025) also concluded that PRF may aid peri implant gap fill and soft-tissue healing in immediate implant contexts, but called for better standardized trials and clearer indications.
Beyond PRF alone, two "composite" concepts have gained attention: sticky tooth and sticky bone. Sticky tooth generally refers to autogenous tooth-derived dentin granules combined with platelet concentrates to create a cohesive graft, leveraging dentin's mineral and collagen composition and its proposed bioactivity. In a histologic evaluation, van Orten et al. (2022) described tooth-derived granules mixed with PRF ("sticky tooth") as a feasible socket preservation approach with histologic evidence of graft integration patterns consistent with bone remodeling, supporting its potential as an autogenous biomaterial with low immunologic risk. Separately, tooth-derived grafts have been increasingly investigated as alternatives to xenografts/allografts, yet protocols vary widely in processing, particle size, sterilization, and mixing with blood products-creating a knowledge gap regarding standardization and reproducibility across centers.
Sticky bone most commonly refers to particulate bone substitute (often xenograft or allograft) combined with injectable PRF (i-PRF) to form a moldable, fibrin-rich mass intended to improve handling, stabilize particles, and potentially enhance early biologic activity. In a randomized parallel-arm clinical trial, Tony et al. (2022) assessed sticky bone for horizontal ridge augmentation using CBCT outcomes, supporting that i-PRF-based composites can be evaluated quantitatively and may influence hard-tissue results depending on adjunctive membrane use.
Collectively, these findings suggest a strong rationale to test whether sticky tooth and sticky bone can serve as optimized fillers for the shield-implant gap in SST-where space maintenance, clot stability, and early vascularization may be decisive.
High-quality assessment of subtle contour changes requires accurate, reproducible measurement methods. Contemporary digital workflows combine CBCT with intraoral scanning (IOS) to enable three-dimensional planning, guided surgery, and longitudinal volumetric evaluation. A key technical step is accurate CBCT-IOS registration and superimposition. In a systematic review and meta-analysis, Zheng et al. (2025) concluded that automatic multimodal registration methods-particularly those incorporating AI-have improved efficiency and robustness, but performance can still be affected by landmark instability, artifact burden, and dataset diversity, indicating a need for clinically validated workflows in implant planning and follow-up. Similarly, Flügge et al. (2017) demonstrated that digital model registration accuracy is clinically relevant and must be managed carefully to avoid propagating errors into guided surgery and outcome assessment, supporting strict standardization in trials that use superimposition as a primary endpoint. Within SST specifically, Zhang et al. (2020) introduced the clinical concept of guided residual root preparation to reduce technique sensitivity and improve repeatability of shield preparation, indicating that guided approaches may address one of SST's main drawbacks-operator variability.
Artificial intelligence is increasingly integrated into implant dentistry, particularly in image segmentation, automated registration, planning support, and outcome prediction. Altalhi et al. (2023) summarized current and emerging AI applications in implantology, including planning precision and the movement toward more automated, data-driven workflows, while also cautioning that validation and transparency are essential before widespread clinical dependence. In a foundational perspective, Schwendicke et al. (2020) argued that AI in dentistry offers clear opportunities in decision support and automation, but requires high-quality training data, rigorous evaluation, and careful governance to ensure safe clinical translation . In the context of the present work, AI-assisted planning after IOS superimposition could strengthen the standardization of implant positioning and patient-specific guide fabrication, thereby reducing confounding variability and allowing a clearer comparison of biologic gap-filling materials
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- grafting the shield/fixture gap with leukocyte-platelet rich fibrin (L-PRF)
| Arm | Type | Receives |
|---|---|---|
| PRF alone group | Active comparator | Procedure: Socket shield with PRFImmediately after implant placement, leukocyte-platelet rich fibrin (L-PRF) will be prepared, then gently packed into the implant-shield gap |
| Sticky tooth group | Experimental | Procedure: Sticky tooth groupThe extracted palatal root portion will be cleaned and processed chairside into dentin particles, then mixed with PRF clot to form "sticky tooth" that will be packed into the implant-shield gap |
| Sticky bone group | Experimental | Procedure: Sticky bonegroupxenograft will be mixed with PRF clot to form "sticky bone" that will be packed into the implant-shield gap |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Medically healthy patients according to the American Society of Anesthesiologists (ASA) physical status classification system; only patients belonging to ASA I and ASA II categories will be included in this study.
- Age > 18 years.
- Patients presenting with one non-restorable hopeless anterior tooth due to extensive caries, cervical/root fracture, vertical or oblique root fracture, multiple failed endodontic treatments, or root resorption.
- Sufficient apical/palatal bone to obtain primary implant stability.
Key exclusion criteria (6 listed)
- Patients belonging to ASA III, ASA IV and ASA V will be excluded.
- Vertical root fracture involving the labial aspect of the root planned to be retained as the facial shield.
- Horizontal root fracture that is too far apically located.
- Presence of acute (active) periapical infection.
- Large chronic periapical lesion.
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 |
|---|---|---|
| Socket shield with PRFshield/implant gap will be grafted by PRF alone | Procedure or surgery | PRF alone group |
| Sticky tooth groupshield/implant gap will be grafted by sticky tooth graft | Procedure or surgery | Sticky tooth group |
| Sticky bonegroupshield/implant gap will be grafted by sticky xenograft | Procedure or surgery | Sticky bone group |
Primary outcome
marginal bone level
Time frame: 12 months
marginal bone level (FMBL) will be recorded as the vertical distance (mm) from the implant shoulder (or implant platform reference) to the most coronal point of the facial bone crest on the midfacial aspect
1 secondary outcome
Peri-implant vertical bone defect depth
Time frame: 12 months
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 18 Mar 2026.
- Individual participant dataSharing planned: No. IPD 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.
Nour Hatata, Phd contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socket shield with PRF, Sticky tooth group and Sticky bonegroup in people with Dental Implant Failed, run by Kafrelsheikh University at 2 sites 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 6 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 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Walid Elamrousy, PhD (+201029552024, waled_hammed@den.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marginal bone level (time frame: 12 months). 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 18 Mar 2026.