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

Launched by SEMMELWEIS UNIVERSITY · Jul 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new material called biphasic calcium sulfate (BCS) used in a surgery known as sinus floor elevation (SFE). This surgery is often necessary for patients who have lost some bone in their upper jaw, typically due to changes in the maxillary sinus. The goal of the study is to see how well BCS works as a bone graft during this procedure, how the bone heals over time, and how successful dental implants placed in this new bone are.

To participate in this trial, you should be at least 18 years old and need dental implants due to insufficient bone height in the back part of your upper jaw. However, certain health issues could exclude you, such as serious systemic diseases, recent radiation treatment to the head or neck, or any uncontrolled dental diseases. If you join the trial, expect to undergo the SFE surgery, and over the next 2 to 9 months, your healing will be monitored. This study is currently recruiting participants of all genders in the age range of 65 to 74 years.

Gender

ALL

Eligibility criteria

• 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