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

Not Applicable

Completed

• Conditions: Bone Substitutes; Bone Regeneration; Atrophy; Jaw, Edentulous, Partially; Sinus Floor Augmentation
• Interventions: Procedure: Sinus floor augmentation

• Registration Number: NCT03496688
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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.

Detailed 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).

Study Timeline

• Study Start: 2015-01-12
• Primary Completion: 2016-01-04
• Study Completion: 2017-09-11
• Study First Submitted: 2018-03-29
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-05
• Last Update Submitted: 2018-04-05
• Study First Posted: 2018-04-12
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bone substitute material EB	Sinus floor augmentation	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.
bone substitute material ABB	Sinus floor augmentation	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.
bone substitute material BC	Sinus floor augmentation	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.
bone substitute material MCBA	Sinus floor augmentation	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.
bone substitute material HA-β-TCP 30/70	Sinus floor augmentation	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.
bone substitute material FDBA	Sinus floor augmentation	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.

Primary Outcome Measures

Name	Time	Method
to perform biopsies from each six augmented site using to compare, histologically and histomorphometrically, the percentages of newly formed bone, residual grafted material, and marrow spaces.	6 month-healing after surgery	After 6 months clinical and radiographic examinations were undertaken and each patient was reappointed for biopsy at the time of implant placement in the same location. Under local anesthesia, a full thickness flap was raised, a biopsy was performed using a 3.5 mm tre-phine bur under sterile saline solution irrigation, guided by the radiographic/surgical template in the selected implant site. A total of six bone samples was retrieved from the occlusal aspect to the alveolar crest, one from each augmented site to compare histologically and histomorphometrically the different materials.