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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

63mo left

Started Aug 2024

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7 years study duration

Study Progress26%

Aug 2024Sep 2031

First Submitted

Initial submission to the registry

July 24, 2024

Completed

8 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed

23 days until next milestone

Study Start

First participant enrolled

August 24, 2024

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected

5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2031

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

July 24, 2024

Last Update Submit

April 21, 2026

Conditions

Alveolar Bone Loss Edentulism Nos

Keywords

bone graft materialbiphasic calcium sulfatesinus floor elevationsinus liftmaxillary sinus augmentationmicrocomputed tomographycone beam computed tomographyhistologyhistomorphometrydental implant

Outcome Measures

Primary Outcomes (3)

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.
3 or 6 months
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
5 years
Success of the implant borne prostheses
Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.
5 years

Secondary Outcomes (11)

Hisomorphometry: Percent of residual bone graft particles
3-6 months
Hisomorphometry: Percent of newly formed bone
3-6 months
Hisomorphometry: Percent of bone marrow
3-6 months
Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples.
3-6 months
Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples.
3-6 months
+6 more secondary outcomes

Study Arms (2)

3-month healing period

EXPERIMENTAL

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.

Procedure: Sinus floor elevation (SFE)Diagnostic Test: preoperative cone beam computed tomography (CBCT)Diagnostic Test: postoperative CBCTDiagnostic Test: bone core biopsyProcedure: dental implant placementProcedure: fixed dental prosthesis (FDP) fabricationDevice: bone grafting

6-month healing period

EXPERIMENTAL

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.

Interventions

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.

Also known as: sinus lift surgery, maxillary sinus augmentation