Sinus Augmentation With Allograft-Bone Substitute in Severe Maxillary Atrophy

NCT07186166 | Completed

• 1 other identifier: CTUMP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Histological outcomes

  Histomorphometric evaluation of core biopsies obtained 6 months after maxillary sinus augmentation to quantify the percentage of newly formed bone, residual graft material, and connective tissue. Data will be summarized as mean ± SD and compared between groups.

  Baseline (T0), After 6 months (T6)

Study Arms (1)

Lateral Window Sinus Floor Augmentation with 30% HA + 70% β-TCP Graft

EXPERIMENTAL

A prospective single-arm clinical trial was conducted on 60 posterior maxillary edentulous sites in 42 patients with residual bone height \< 4 mm. All sites underwent LWSFA, followed by grafting with a 1:1 ratio of 30% HA and 70% β-TCP. At 6 months post-operation, core biopsies were collected during implant placement for histologic evaluation of the grafted sites.

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

Interventions

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

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.

Lateral Window Sinus Floor Augmentation with 30% HA + 70% β-TCP Graft

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a residual bone height ≤4 mm
• minimum prosthetic space of 5 mm

You may not qualify if:

• Patients with acute or chronic maxillary sinusitis, bleeding disorders, diabetes mellitus, bone metabolic diseases, periodontal disease, or malignancies were excluded.
• taking medications that could affect bone metabolism or hemostasis
• Smokers and pregnant women were also excluded from the study.

Sponsors & Collaborators

• Can Tho University of Medicine and Pharmacy: lead

Study Sites (1)

Can Tho University of Medicine and Pharmacy

Can Tho, 90000, Vietnam

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 22, 2025
• Study Start: January 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)