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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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.

Walid Elamrousy, PhD contact

+201029552024

waled_hammed@den.kfs.edu.eg

Nour Hatata, Phd contact

+2025170737

Egypt2 sites, 2 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

    Recruiting

Other trials in Egypt

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

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 groups in NCT07433920
Study groupRoleWhat they receive
PRF alone groupActive comparatorImmediately 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 groupExperimentalThe 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 groupExperimentalxenograft 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.

  1. 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)
  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.

  1. First posted25 Feb 2026
  2. Study start23 Feb 2026
  3. Primary completion3 Mar 2027 (estimated)
  4. Study completion28 Mar 2027 (estimated)

Resources

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)
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

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.

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