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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-12

Study Completion Date

2017-09-11

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Atrophy Jaw, Edentulous, Partially Sinus Floor Augmentation Bone Substitutes Bone Regeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized,controlled, double-blind clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participant, Investigator, Outcome Assessor

Study Groups

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bone substitute material MCBA

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.

Group Type ACTIVE_COMPARATOR

Sinus floor augmentation

Intervention Type PROCEDURE

bone substitute material FDBA

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.

Group Type ACTIVE_COMPARATOR

Sinus floor augmentation

Intervention Type PROCEDURE

bone substitute material ABB

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.

Group Type ACTIVE_COMPARATOR

Sinus floor augmentation

Intervention Type PROCEDURE

bone substitute material EB

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.

Group Type ACTIVE_COMPARATOR

Sinus floor augmentation

Intervention Type PROCEDURE

bone substitute material HA-β-TCP 30/70

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.

Group Type ACTIVE_COMPARATOR

Sinus floor augmentation

Intervention Type PROCEDURE

bone substitute material BC

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.

Group Type ACTIVE_COMPARATOR