Health TrialsbyHealthPanel

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

ConditionsAlveolar Bone LossEdentulism Nos
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSemmelweis University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sinus floor elevation (SFE)

    Procedure/Surgery

    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.

  • 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/Surgery

    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/Surgery

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: 3-month healing periodExperimental treatment 7 interventions
Group B: 6-month healing periodExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Success of the SFE

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.

Time frame
3 or 6 months
2

Success of the dental implants

According to The International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Success (optimum health) 1. No pain or tenderness upon function 2. 0 mobility 3. less than 2 mm radiographic bone loss from initial surgery 4. No exudates in the patient's history II. Satisfactory survival 1. No pain on function 2. 0 mobility 3. 2-4 mm radiographic bone loss 4. No exudates in the patient's history III. Compromised survival 1. May have sensitivity on function 2. No mobility 3. Radiographic bone loss of more than 4 mm (less than1/2 of the length of the implant body) 4. Probing depth more than 7 mm 5. May have exudates in the patient's history IV. Failure (clinical or absolute failure) Any of the following: 1. Pain on function 2. Mobility 3. Radiographic bone loss of more than 1/2 length of the implant 4. Uncontrolled exudate 5. Implant no longer in mouth

Time frame
5 years
3

Success of the implant borne prostheses

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

Time frame
5 years

Secondary outcomes

1

Hisomorphometry: Percent of residual bone graft particles

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

Time frame
3-6 months
2

Hisomorphometry: Percent of newly formed bone

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

Time frame
3-6 months
3

Hisomorphometry: Percent of bone marrow

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

Time frame
3-6 months
4

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

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

Time frame
3-6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Semmelweis University

Lead sponsor

Source ClinicalTrials.gov
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