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

NCT07433920 | Recruiting DMC

• 1 other identifier: KFSIRB200-925
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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. 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 .

Conditions

Dental Implant Failed

Outcome Measures

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

  12 months

Secondary Outcomes (1)

• Peri-implant vertical bone defect depth

  12 months

Study Arms (3)

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

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

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

Procedure: Sticky bonegroup

Interventions

Socket shield with PRF PROCEDURE

shield/implant gap will be grafted by PRF alone

PRF alone group

Sticky tooth group PROCEDURE

shield/implant gap will be grafted by sticky tooth graft

Sticky tooth group

Sticky bonegroup PROCEDURE

shield/implant gap will be grafted by sticky xenograft

Sticky bone group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (2)

faculty of dentistry, kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 214312, Egypt

RECRUITING

Walid Elamrousy

Kafr ash Shaykh, 76130, Egypt

RECRUITING

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Central Study Contacts

Walid Elamrousy, PhD

CONTACT

+201029552024; waled_hammed@den.kfs.edu.eg

Nour Hatata, Phd

CONTACT

+2025170737

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcome assessor is masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of periodontology, Faculty of Oral and Dental Medicine, Kafrelsheikh University

Model Details: grafting the shield/fixture gap with leukocyte-platelet rich fibrin (L-PRF)

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 25, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): March 3, 2027
• Study Completion (Estimated): March 28, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)