Status:

RECRUITING

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

Lead Sponsor:

Semmelweis University

Conditions:

Alveolar Bone Loss

Edentulism Nos

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 24 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 1 2031

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT06533397

    Start Date

    August 24 2024

    End Date

    September 1 2031

    Last Update

    November 29 2024

    Active Locations (1)

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    1

    Semmelweis University Department of Public Dental Health

    Budapest, Budapest, Hungary, 1088