Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06533397

The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation

Led by Semmelweis University · Updated on 2026-04-24

40

Participants Needed

1

Research Sites

366 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Pneumatization of the maxillary sinus may lead to insufficient bone volume for dental implant placement in the edentulous posterior maxilla. Sinus floor elevation (SFE) surgery with the lateral window technique is a safe and predictable surgical intervention to restore bone height in the maxillary premolar and molar areas. According to the literature, several bone graft materials may be successfully applied for SFE surgery. There is a lack of evidence regarding the application of biphasic calcium sulfate (BCS) for SFE. The healing period following staged SFE is 2-9 months. The aim of this study is: * to evaluate the success of SFE surgery using BCS as graft material, * to compare the microarchitecture of the augmented bone depending on the healing period, * to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.

CONDITIONS

Official Title

The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over the age of 18 years
  • Patients who need dental implant-borne prostheses
  • Patients with insufficient bone height in the posterior maxilla due to sinus pneumatization
Not Eligible

You will not qualify if you...

  • Patients with major systemic diseases classified as ASA grades III-IV
  • Patients with psychiatric contraindications
  • Patients on medications affecting bone metabolism, including steroids and antiresorptives
  • Patients who had radiation to the head or neck region within the last five years
  • Patients with localized periapical disease, cysts, or maxillary sinusitis
  • Patients with uncontrolled periodontal disease
  • Patients with Alcohol Use Disorder as defined by DSM-5
  • Patients with recreational drug abuse
  • Heavy smokers (more than 10 cigarettes per day)
  • Patients with diseases of the oral mucosa including blisters, ulcers, precancerous or cancerous lesions, and other specified conditions
  • Pregnant or nursing patients
  • Patients with poor oral hygiene

AI-Screening

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Trial Site Locations

Total: 1 location

1

Semmelweis University Department of Public Dental Health

Budapest, Budapest, Hungary, 1088

Actively Recruiting

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Research Team

M

Márton Kivovics, DMD,MSD,PHD

CONTACT

D

Dorottya Pénzes, DMD,MSD,PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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