Comparative Results of Six Biomaterials Used in Two-stage Maxillary Sinus

University of Roma La Sapienza

Status: Completed

Conditions: Jaw, Edentulous, Partially; Sinus Floor Augmentation; Atrophy; Bone Substitutes; Bone Regeneration

Treatments: Procedure: Sinus floor augmentation

Study type: Interventional

Funder types: Other

Identifiers

NCT03496688

3447/18.12.2014

Details and patient eligibility

About

Objectives: The aim of the study was to compare histological and histomorphometric results of six bone substitute materials used as graft in two-stage maxillary sinus augmentation model, after 6-month-healing.

Full description

Materials and Methods:

A two-stage sinus augmentation was carried out in six patients using mineralized solvent-dehydrated bone allograft (MCBA), freeze-dried mineralized bone allograft (FDBA), anor-ganic bovine bone (ABB), equine-derived bone (EB); synthetic micromacroporous biphasic calcium-phosphate block consisting of 70% beta-tricalcium phosphate and 30% hydroxyap-atite (HA-β-TCP 30/70), or bioapatite-collagen (BC).

Enrollment: 6 patients

Sex: All

Ages: 33 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: patients healthy, absence of systemic pathologies (ASA class I), non-smokers, good oral hygiene, not pregnant or lactating, absence of painful symptoms and associated inflammatory or osteolytic pathologies, maxillary partial edentulism involving the premolar/molar areas, residual bone height between the sinus floor and alveolar ridge ranging from 2 to 4 mm, as measured on computerized tomography (CT) scan.

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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6 participants in 6 patient groups

bone substitute material MCBA

Active Comparator group

Description:

Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using mineralized sol-vent-dehydrated bone allograft material.

Treatment:

Procedure: Sinus floor augmentation

bone substitute material FDBA

Active Comparator group

Description:

Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using freeze-dried mineralized bone allograft material.

Treatment:

Procedure: Sinus floor augmentation

bone substitute material ABB

Active Comparator group

Description:

Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using anorganic bovine bone material.

Treatment:

Procedure: Sinus floor augmentation

bone substitute material EB

Active Comparator group

Description:

Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using equine-derived bone material.

Treatment:

Procedure: Sinus floor augmentation

bone substitute material HA-β-TCP 30/70

Active Comparator group

Description:

Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using synthetic micromacroporous bi-phasic calcium-phosphate block consisting of 70% beta-tricalcium phosphate and 30% hy-droxyapatite material.

Treatment:

Procedure: Sinus floor augmentation

bone substitute material BC

Active Comparator group

Description:

Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using bioapatite-collagen material.

Treatment:

Procedure: Sinus floor augmentation