L-PRF Versus Sticky Bone Grafting of the Jumping Gap in AI-assisted Computer-Guided Socket Shield Immediate Implantation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorKafrelsheikh University

About this 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 .

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Socket shield with PRF

    Procedure/Surgery

    shield/implant gap will be grafted by PRF alone

  • Sticky tooth group

    Procedure/Surgery

    shield/implant gap will be grafted by sticky tooth graft

  • Sticky bonegroup

    Procedure/Surgery

    shield/implant gap will be grafted by sticky xenograft

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: PRF alone groupActive comparator 1 intervention
Group B: Sticky tooth groupExperimental treatment 1 intervention
Group C: Sticky bone groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame
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

Time frame
12 months

Other outcomes

Sponsors and contacts

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