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
Verified date | April 2018 |
Source | University of Roma La Sapienza |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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: |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
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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