Clinical trial NCT06533397: The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Official title: The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alveolar Bone Loss
Edentulism Nos
Keywords: bone graft material
biphasic calcium sulfate
sinus floor elevation
sinus lift
maxillary sinus augmentation
microcomputed tomography
cone beam computed tomography
histology
histomorphometry
dental implant
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Success of the SFE
timeFrame: 3 or 6 months
measure: Success of the dental implants
timeFrame: 5 years
measure: Success of the implant borne prostheses
timeFrame: 5 years
Secondary outcomes:
measure: Hisomorphometry: Percent of residual bone graft particles
timeFrame: 3-6 months
measure: Hisomorphometry: Percent of newly formed bone
timeFrame: 3-6 months
measure: Hisomorphometry: Percent of bone marrow
timeFrame: 3-6 months
measure: Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples.
timeFrame: 3-6 months
measure: Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples.
timeFrame: 3-6 months
measure: Value of the trabecular thickness (Tb.Th.), calculated from the microCT reconstructions of the bone core biopsy samples.
timeFrame: 3-6 months
measure: Value of the trabecular separation (Tb.Sp.), calculated from the microCT reconstructions of the bone core biopsy samples.
timeFrame: 3-6 months
measure: Value of the trabecular bone pattern factor (Tb.Pf), calculated from the microCT reconstructions of the bone core biopsy samples.
timeFrame: 3-6 months
measure: Value of the structure model index (SMI), calculated from the microCT reconstructions of the bone core biopsy samples.
timeFrame: 3-6 months
measure: Value of the Total porosity (Po(tot)), calculated from the microCT reconstructions of the bone core biopsy samples.
timeFrame: 3-6 months
measure: Value of the Connectivity (Conn.), calculated from the microCT reconstructions of the bone core biopsy samples.
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Department of Public Dental Health
Study officials:
affiliation: Department of Public Dental Health, Semmelweis University
name: Márton Kivovics, DMD,MSD,PHD
role: PRINCIPAL_INVESTIGATOR
References: