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Sinus Augmentation With Allograft-Bone Substitute in Severe Maxillary Atrophy

NCT07186166 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-22

No results posted yet for this study

Summary

This study was conducted in two phases. In Phase 1, lateral window sinus floor augmentation was performed using a mixture of hydroxyapatite (30%) and β-tricalcium phosphate (70%) combined with autologous platelet-rich fibrin (PRF). Standard surgical protocols were followed, including prophylactic antibiotics, local anesthesia, and careful elevation of the Schneiderian membrane prior to graft placement.

In Phase 2, after six months of healing, core bone biopsies were harvested with a trephine drill at the planned implant site for histological analysis. Specimens were processed using standardized laboratory protocols and evaluated with light microscopy and digital imaging. Quantitative histomorphometric analysis was performed using ImageJ software to determine the area fractions of newly formed bone and residual graft material. Following biopsy retrieval, dental implants were placed and primary stability was measured with the Implant Stability Quotient (ISQ).

Conditions

  • Implant Site Reaction

Interventions

COMBINATION_PRODUCT

30% HA+70% β-TCP (Osteon II, Dentium, Korea)

A prospective analysis was performed on a single-arm clinical trial involving 60 posterior maxillary edentulous sites in 42 patients with a residual bone height of \<4 mm. All sites were treated with lateral window sinus floor augmentation (LWSFA), followed by grafting using a 1:1 ratio of 30% HA with 70% β-TCP (Osteon II, Dentium, Korea). At 6 months postoperatively, core biopsies were harvested during implant placement to assess the histological outcomes of the grafted sites.

Sponsors & Collaborators

  • Can Tho University of Medicine and Pharmacy

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-02-01
Completion
2024-02-01

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07186166 on ClinicalTrials.gov