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Evaluation of Lateral Sinus Floor Elevation Using Xenograft Versus L-PRF Block Combined With Xenograft

24. juni 2026 opdateret af: Gulf Medical University

Evaluation of Lateral Sinus Floor Elevation Using Xenograft Versus L-PRF Block Combined With Xenograft: A Randomized Controlled Clinical Trial

Rehabilitation of the posterior maxilla with dental implants is frequently complicated by insufficient residual bone height resulting from alveolar ridge resorption and maxillary sinus pneumatization. Lateral sinus floor elevation has become a predictable and widely accepted procedure for increasing bone volume and enabling implant placement in severely atrophic posterior maxillary sites. The long-term success of this procedure is largely dependent on the grafting material used to maintain space beneath the elevated Schneiderian membrane and promote new bone formation.

Deproteinized bovine bone mineral (DBBM), commonly known as xenograft, remains the most extensively documented grafting material for sinus augmentation due to its osteoconductive properties, volumetric stability, and favorable long-term clinical outcomes. However, xenografts are characterized by slow remodeling and prolonged persistence of residual graft particles, which may delay replacement by vital bone. Consequently, strategies to enhance the biological activity of xenografts and accelerate bone regeneration have become an area of considerable research interest.

Leukocyte- and platelet-rich fibrin (L-PRF) is a second-generation autologous platelet concentrate containing a fibrin matrix enriched with platelets, leukocytes, cytokines, and growth factors including platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), and transforming growth factor-β (TGF-β). These biological mediators may enhance angiogenesis, accelerate wound healing, stimulate osteoblast proliferation, and improve bone regeneration.

Several studies have demonstrated promising outcomes when L-PRF is used in sinus augmentation procedures. Mazor et al. reported successful bone formation and implant placement following sinus augmentation using PRF as the sole grafting material after six months of healing. Histological analysis demonstrated the formation of newly regenerated vital bone within the augmented sinus compartment.

More recently, Cortellini et al. conducted a randomized controlled trial comparing L-PRF block and DBBM in lateral sinus floor elevation. Although both techniques allowed successful implant placement after six months, differences in volumetric stability and graft remodeling were observed. The authors suggested that L-PRF-containing grafts may represent a biologically active alternative capable of enhancing healing while maintaining sufficient bone volume for implant placement.

Pichotano et al. further demonstrated that combining L-PRF with DBBM accelerated bone maturation and facilitated earlier implant placement when compared with xenograft alone. Histomorphometric findings revealed greater percentages of newly formed bone and reduced healing times in the L-PRF group.

Despite these promising findings, the available evidence remains limited, and there is no clear consensus regarding whether the addition of L-PRF to xenografts results in clinically significant improvements in bone regeneration, volumetric maintenance, and implant site development. Therefore, a randomized controlled clinical trial comparing xenograft alone versus L-PRF block combined with xenograft during lateral sinus floor elevation is warranted.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Adults aged 21 years or older.
  • Partially edentulous posterior maxilla requiring implant-supported rehabilitation.
  • Residual bone height between 2 and 5 mm measured by CBCT.
  • Good oral hygiene and compliance with maintenance visits.
  • ASA I or II patients.
  • Signed informed consent.

Exclusion Criteria:

  • Uncontrolled systemic diseases.
  • Smoking more than 10 cigarettes/day.
  • Active sinus pathology or chronic sinusitis.
  • Previous sinus augmentation surgery.
  • Pregnancy or lactation.
  • Bisphosphonate therapy.
  • Immunocompromised patients.
  • History of head and neck radiotherapy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Lateral sinus floor elevation using: DBBM xenograft (Bio-Oss®)

Following local anesthesia, a full-thickness mucoperiosteal flap will be elevated.

A lateral bony window will be created using piezoelectric surgery to minimize the risk of Schneiderian membrane perforation (4).

The sinus membrane will be carefully elevated and the resulting compartment will be grafted using deproteinized bovine bone mineral (DBBM).

A resorbable collagen membrane will be placed over the lateral window before flap closure.

Eksperimentel: Lateral sinus floor elevation using DBBM xenograft (Bio-Oss®) and L-PRF

The same surgical protocol will be followed. Immediately before surgery, venous blood will be collected and centrifuged according to the Choukroun L-PRF protocol (5).

The obtained L-PRF membranes will be fragmented and mixed with DBBM particles to create an L-PRF block.

The graft mixture will be placed beneath the elevated sinus membrane. Additional L-PRF membranes will be used to cover the lateral window before flap closure.

This protocol follows previously published clinical methodologies evaluating L-PRF-enhanced sinus augmentation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Vertical Bone Gain
Tidsramme: 6 months
mm in CBCT
6 months
Histomorphometric Bone Formation (%)
Tidsramme: 6 months

At six months, during implant placement, a trephine bur will be used to harvest a bone core biopsy from the grafted area.

Specimens will be fixed, decalcified, sectioned, stained, and analyzed histomorphometrically.

The following parameters will be quantified:

  • Percentage of newly formed bone.
  • Percentage of residual graft particles.
  • Percentage of connective tissue. Histomorphometric analysis remains the gold standard for evaluating bone regeneration following sinus augmentation
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative pain and Morbidity VAS score 0-10
Tidsramme: Days 1, 3, and 7 postoperatively
VAS score 0-10
Days 1, 3, and 7 postoperatively
Surgical Complications
Tidsramme: baseline
  • Schneiderian membrane perforation.
  • Infection.
  • Graft exposure.
  • Sinusitis.
  • Wound dehiscence.
baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2026

Primær færdiggørelse (Anslået)

1. januar 2027

Studieafslutning (Anslået)

1. februar 2027

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier

24. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • Sinus-L-PRF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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