Using a special bone graft for sinus floor elevation in dental procedures

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

This study is testing a special bone graft to see if it helps people with not enough bone in their upper jaw get better results from dental implants after sinus surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Semmelweis University (other)
• Drugs / interventions: radiation
• Locations: 1 site (Budapest, Budapest)
• Trial ID: NCT06533397 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of biphasic calcium sulfate (BCS) as a graft material in sinus floor elevation (SFE) surgery, which is performed to restore bone height in the maxillary region for dental implants. The research aims to assess the success of SFE using BCS, analyze the microarchitecture of the augmented bone over different healing periods, and evaluate the outcomes of dental implants placed in the augmented bone. Patients will undergo preoperative and postoperative imaging to monitor the results. The study focuses on individuals with insufficient bone height due to sinus pneumatization.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 who require dental implants and have insufficient bone height in the posterior maxilla due to sinus issues.

Not a fit: Patients with major systemic diseases, psychiatric contraindications, or those on medications affecting bone metabolism may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve dental implant success rates for patients with insufficient bone volume in the maxilla.

How similar studies have performed: While there is limited evidence on the use of biphasic calcium sulfate for SFE, other studies have shown success with various bone graft materials in similar procedures.

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

Where this trial is running

Budapest, Budapest

• Semmelweis University Department of Public Dental Health — Budapest, Budapest, Hungary (RECRUITING)

Study contacts

• Principal investigator: Márton Kivovics, DMD,MSD,PHD — Department of Public Dental Health, Semmelweis University
• Study coordinator: Márton Kivovics, DMD,MSD,PHD

Conditions: Alveolar Bone Loss, Edentulism Nos, bone graft material, biphasic calcium sulfate, sinus floor elevation, sinus lift, maxillary sinus augmentation, microcomputed tomography