- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433920
L-PRF Versus Sticky Bone Grafting of the Jumping Gap in AI-assisted Computer-Guided Socket Shield Immediate Implantation
L-PRF Versus Sticky Bone Grafting of the Jumping Gap in AI-assisted/Computer-Guided Socket Shield Immediate Dental Implantation: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Walid Elamrousy, PhD
- Phone Number: +201029552024
- Email: waled_hammed@den.kfs.edu.eg
Study Contact Backup
- Name: Nour Hatata, Phd
- Phone Number: +2025170737
Study Locations
-
-
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Kafr ash Shaykh, Egypt, 76130
- Recruiting
- Walid Elamrousy
-
Contact:
- walid elamrousy, phd
- Phone Number: +201005724781
- Email: Waled_Hammed@den.kfs.edu.eg
-
Contact:
- mostafa fayed, bachelor
- Phone Number: +201063376252
-
-
Kafrelsheikh
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Kafr ash Shaykh, Kafrelsheikh, Egypt, 214312
- Recruiting
- faculty of dentistry, kafrelsheikh University
-
Contact:
- walid elamrousy
- Phone Number: +201005724781
- Email: Waled_Hammed@den.kfs.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PRF alone group
Immediately after implant placement, leukocyte-platelet rich fibrin (L-PRF) will be prepared, then gently packed into the implant-shield gap
|
shield/implant gap will be grafted by PRF alone
|
|
Experimental: Sticky tooth group
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
|
shield/implant gap will be grafted by sticky tooth graft
|
|
Experimental: Sticky bone group
xenograft will be mixed with PRF clot to form "sticky bone" that will be packed into the implant-shield gap
|
shield/implant gap will be grafted by sticky xenograft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peri-implant vertical bone defect depth
Time Frame: 12 months
|
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
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KFSIRB200-925
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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