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NCT03496688 Clinical Trial

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

Jaw, Edentulous, Partially Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03496688
Other study ID # 3447/18.12.2014
Secondary ID
Status Completed
Phase N/A
First received March 29, 2018
Last updated April 5, 2018
Start date January 12, 2015
Est. completion date September 11, 2017

Study information
Verified date April 2018
Source University of Roma La Sapienza
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date September 11, 2017
Est. primary completion date January 4, 2016
Accepts healthy volunteers No
Gender All
Age group 33 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Sinus floor augmentation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Roma La Sapienza

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 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. 6 month-healing after surgery
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