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NCT Number: NCT06533397

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

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.

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Key information

Conditions

Alveolar Bone Loss Bone Diseases Bone Resorption Edentulism Nos Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University Department of Public Dental Health

Budapest, 1088, Hungary

Location status: Recruiting

Location contact

Márton Kivovics, DMD MSc PhD

CONTACT

[email protected]

003614591500 ext. 60732

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sinus floor elevation (SFE)

Procedure

Patients rinse with 0.2% chlorhexidine solution for one minute before surgery. Under local anesthesia, a mucoperiosteal flap is raised from a midcrestal incision and two relieving incisions. Lateral window osteotomies are carried out using diamond burs. The Schneiderian membrane is carefully elevated and the synthetic bone graft material (Bond Apatite, Augma Biomaterials, Cesarea, Israel) (2-3 cm3) is packed in the defect with light force. The buccal flap is then mobilized to allow tension-free primary closure. The margins are stabilized with single interrupted sutures. Antibiotics (1 g amoxicillin-clavulanate twice a day for 5 days, or in case of side effects or known allergy to penicillin, 300 mg clindamycin 4 times a day for 4 days), anti-inflammatory drugs (50 mg diclofenac 3 times a day for 3 days), and chlorhexidine mouthwash (twice a day for 21 days from the first day after surgery) are prescribed. Suture removal takes place after 10 days.

Other names: sinus lift surgery, maxillary sinus augmentation

preoperative cone beam computed tomography (CBCT)

Diagnostic Test

A CBCT scan is performed before SFE surgery to evaluate the anatomy and pathologies of the maxillary sinus.

postoperative CBCT

Diagnostic Test

A CBCT scan is performed following the 3- or 6-month-long healing period after SFE to evaluate the anatomy and healing of the augmented bone and the maxillary sinus.

Bone core biopsy

Diagnostic Test

At the time of dental implant placement, the first step of the implant bed preparation is performed using a trephine drill to harvest a bone core biopsy sample from the augmented bone. The biopsy sample is harvested from the implant bed, this way the patient is spared of excess surgical burden as this bone would be removed even if no biopsy sample was harvested during dental implant placement. The bone core biopsy samples are subjected to histomorphometric and microCT analysis.

Dental implant placement

Procedure

Following the 3- or 6-month-long healing period following SFE, dental implants are placed non-submerged in the augmented bone under local anesthesia.

Fixed dental prosthesis (FDP) fabrication

Procedure

3 months after dental implant placement, fixed dental prostheses are delivered on the dental implants.

Bone grafting

Device

A synthetic bone graft material (Bond Apatite, Augma Biomaterials, Cesarea, Israel) is used during SFE.

Primary outcomes

  1. Success of the SFE

    Time frame: 3 or 6 months

    The SFE surgery is successful if no inflammatory complications occur in the 3- or 6-month-long healing period and the bone volume is sufficient for dental implant placement.

  2. Success of the dental implants

    Time frame: 5 years

    According to The International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference.

    Success (optimum health)

    • No pain or tenderness upon function
    • 0 mobility
    • less than 2 mm radiographic bone loss from initial surgery
    • No exudates in the patient's history

    II. Satisfactory survival

    • No pain on function
    • 0 mobility
    • 2-4 mm radiographic bone loss
    • No exudates in the patient's history

    III. Compromised survival

    • May have sensitivity on function
    • No mobility
    • Radiographic bone loss of more than 4 mm (less than1/2 of the length of the implant body)
    • Probing depth more than 7 mm
    • May have exudates in the patient's history

    IV. Failure (clinical or absolute failure)

    Any of the following:

    • Pain on function
    • Mobility
    • Radiographic bone loss of more than 1/2 length of the implant
    • Uncontrolled exudate
    • Implant no longer in mouth

  3. Success of the implant borne prostheses

    Time frame: 5 years

    Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.

Secondary outcomes

  1. Hisomorphometry: Percent of residual bone graft particles

    Time frame: 3-6 months

    The percentage of residual bone graft particle-area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%)

  2. Hisomorphometry: Percent of newly formed bone

    Time frame: 3-6 months

    The percentage of newly formed bone-area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%)

  3. Hisomorphometry: Percent of bone marrow

    Time frame: 3-6 months

    The percentage of bone marrow-area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%)

  4. Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples.

    Time frame: 3-6 months

    Relative volume of calcified tissue in the selected volume. Unit: none

  5. Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples.

    Time frame: 3-6 months

    Ratio of the segmented bone surface to the total volume in the region of interest. Unit: 1/mm

  6. Value of the trabecular thickness (Tb.Th.), calculated from the microCT reconstructions of the bone core biopsy samples.

    Time frame: 3-6 months

    Mean thickness of the trabeculae, assessed using direct 3D methods. Unit: mm

  7. Value of the trabecular separation (Tb.Sp.), calculated from the microCT reconstructions of the bone core biopsy samples.

    Time frame: 3-6 months

    Mean distance between the trabeculae, assessed using direct 3D methods. Unit: mm

  8. Value of the trabecular bone pattern factor (Tb.Pf), calculated from the microCT reconstructions of the bone core biopsy samples.

    Time frame: 3-6 months

    Indicator of the relation between convex and concave elements in the trabecular bone structure. Tb.Pf <0 when the trabecular bone is honeycomb-like and increases as the trabecular bone acquires a rod-like structure. Unit: none

  9. Value of the structure model index (SMI), calculated from the microCT reconstructions of the bone core biopsy samples.

    Time frame: 3-6 months

    The estimator of the plate- versus rod-like characteristic of the trabecular bone structure, 0 for perfect plates, 3 for perfect rods, and 4 for perfect spheres. Unit: none

  10. Value of the Total porosity (Po(tot)), calculated from the microCT reconstructions of the bone core biopsy samples.

    Time frame: 3-6 months

    Percent porosity is the volume of pores as a percent of the total volume of interest (VOI). Unit: percent (%)

  11. Value of the Connectivity (Conn.), calculated from the microCT reconstructions of the bone core biopsy samples.

    Time frame: 3-6 months

    One useful and fast algorithm for calculating the Euler connectivity in 3D is the "Conneulor". It measures what might be called "redundant connectivity", the degree to which parts of the object are multiply connected. It is a measure of how many connections in a structure can be severed before the structure falls into two separate pieces. Unit: none.

Study contacts

Contact information is provided by the study sponsor or research team.

Dorottya Pénzes, DMD,MSD,PHD

CONTACT

[email protected]

003614591500 ext. 60759

Márton Kivovics, DMD,MSD,PHD

CONTACT

[email protected]

003614591500 ext. 60732

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2031
First posted
Aug 1, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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