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

Semmelweis University

Status

Enrolling

Conditions

Edentulism Nos

Alveolar Bone Loss

Treatments

Procedure: dental implant placement

Procedure: Sinus floor elevation (SFE)

Diagnostic Test: preoperative cone beam computed tomography (CBCT)

Device: bone grafting

Procedure: fixed dental prosthesis (FDP) fabrication

Diagnostic Test: bone core biopsy

Diagnostic Test: postoperative CBCT

Study type

Interventional

Funder types

Other

Identifiers

NCT06533397

SEDCD44

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

3-month healing period

Experimental group

Description:

Staged SFE is performed; following a 3-month-long healing period, bone core biopsy samples are harvested from the augmented bone, and dental implants are placed.

Treatment:

Diagnostic Test: postoperative CBCT

Diagnostic Test: bone core biopsy

Procedure: fixed dental prosthesis (FDP) fabrication

Device: bone grafting

Diagnostic Test: preoperative cone beam computed tomography (CBCT)

Procedure: Sinus floor elevation (SFE)

Procedure: dental implant placement

6-month healing period

Experimental group

Description:

Staged SFE is performed; following a 6-month-long healing period, bone core biopsy samples are harvested from the augmented bone, and dental implants are placed.

Treatment:

Diagnostic Test: postoperative CBCT

Diagnostic Test: bone core biopsy

Procedure: fixed dental prosthesis (FDP) fabrication

Device: bone grafting

Diagnostic Test: preoperative cone beam computed tomography (CBCT)

Procedure: Sinus floor elevation (SFE)

Procedure: dental implant placement