Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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

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

Run by Semmelweis University · NCT06533397 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorSemmelweis University
Academic / other
Drugs / interventionsradiation
Locations1 site (Budapest, Budapest)
StatusRecruiting
StartedAugust 24, 2024
Main results expectedSeptember 2027
Study endsSeptember 2031
Registry record updatedOctober 28, 2026
Trial IDNCT06533397 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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
  • Email: kivovics.marton@semmelweis.hu
  • Phone: 003614591500

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.