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Clinical Trials/NCT03496688
NCT03496688
Completed
Not Applicable

Comparative Histological and Histomorphometric Results of Six Biomaterials Used in Two-stage Maxillary Sinus Augmentation Model After 6-month-healing

University of Roma La Sapienza0 sites6 target enrollmentJanuary 12, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrophy
Sponsor
University of Roma La Sapienza
Enrollment
6
Primary Endpoint
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.
Status
Completed
Last Updated
8 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 12, 2015
End Date
September 11, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Roma La Sapienza
Responsible Party
Principal Investigator
Principal Investigator

Maria Paola Cristalli

DDS PhD, Clinical Professor

University of Roma La Sapienza

Eligibility 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

  • Not provided

Outcomes

Primary Outcomes

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.

Time Frame: 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.

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