Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

Eligibility

Inclusion Criteria:

  • 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.

Exclusion criteria:

.• Patients who had major systemic diseases as classified by the American Society of Anesthesiologists (ASA grades III-IV),

  • psychiatric contraindications,
  • patients on medication interfering with bone metabolism, including steroid therapy and antiresorptive medication,
  • radiation to the head or neck region within the previous five years,
  • localized periapical disease, odontogenic and nonodontogenic cysts, and maxillary sinusitis,
  • evidence of uncontrolled periodontal disease,
  • Alcohol Use Disorder defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5),
  • recreational drug abuse,
  • heavy smoking (>10 cigarettes/day),
  • diseases of the oral mucosa, including blisters and ulcers, i.e.: red and white lesions, pigmented lesions, benign tumors of the oral cavity, and oral cancer. Leukoplakia, Erythroplakia, Precancerous lesions, Oral squamous cell carcinoma and malign tumors of the soft and hard tissues, Oral candidiasis, Oral lichen planus, Psoriasis, Pemphigus, and Pemphigoid.
  • pregnancy or nursing,
  • poor oral hygiene

Study details
    Alveolar Bone Loss
    Edentulism Nos

NCT06533397

Semmelweis University

22 August 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.