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

Last updated: November 26, 2024
Sponsor: Semmelweis University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

bone grafting

postoperative CBCT

Sinus floor elevation (SFE)

Clinical Study ID

NCT06533397
SEDCD44
  • Ages > 18
  • All Genders

Study 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 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 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 sinuspneumatization.

Exclusion

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 therapyand antiresorptive medication,

  • radiation to the head or neck region within the previous five years,

  • localized periapical disease, odontogenic and nonodontogenic cysts, and maxillarysinusitis,

  • evidence of uncontrolled periodontal disease,

  • Alcohol Use Disorder defined by the Diagnostic and Statistical Manual of MentalDisorders, 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 whitelesions, pigmented lesions, benign tumors of the oral cavity, and oral cancer.Leukoplakia, Erythroplakia, Precancerous lesions, Oral squamous cell carcinoma andmalign tumors of the soft and hard tissues, Oral candidiasis, Oral lichen planus,Psoriasis, Pemphigus, and Pemphigoid.

  • pregnancy or nursing,

  • poor oral hygiene

Study Design

Total Participants: 40
Treatment Group(s): 7
Primary Treatment: bone grafting
Phase:
Study Start date:
August 24, 2024
Estimated Completion Date:
September 30, 2031

Connect with a study center

  • Semmelweis University Department of Public Dental Health

    Budapest, 1088
    Hungary

    Active - Recruiting

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