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

Primary Purpose

Atrophy, Jaw, Edentulous, Partially, Sinus Floor Augmentation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sinus floor augmentation
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophy focused on measuring Sinus floor augmentation, Bone regeneration, Histology, Biocompatible materials, Bone transplantation

Eligibility Criteria

33 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    bone substitute material MCBA

    bone substitute material FDBA

    bone substitute material ABB

    bone substitute material EB

    bone substitute material HA-β-TCP 30/70

    bone substitute material BC

    Arm Description

    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.

    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.

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 29, 2018
    Last Updated
    April 5, 2018
    Sponsor
    University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03496688
    Brief Title
    Comparative Results of Six Biomaterials Used in Two-stage Maxillary Sinus
    Official Title
    Comparative Histological and Histomorphometric Results of Six Biomaterials Used in Two-stage Maxillary Sinus Augmentation Model After 6-month-healing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 12, 2015 (Actual)
    Primary Completion Date
    January 4, 2016 (Actual)
    Study Completion Date
    September 11, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Roma La Sapienza

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrophy, Jaw, Edentulous, Partially, Sinus Floor Augmentation, Bone Substitutes, Bone Regeneration
    Keywords
    Sinus floor augmentation, Bone regeneration, Histology, Biocompatible materials, Bone transplantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A randomized,controlled, double-blind clinical trial
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    Participant, Investigator, Outcome Assessor
    Allocation
    Randomized
    Enrollment
    6 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    bone substitute material MCBA
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    bone substitute material FDBA
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    bone substitute material ABB
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    bone substitute material EB
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    bone substitute material HA-β-TCP 30/70
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    bone substitute material BC
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Sinus floor augmentation
    Primary Outcome Measure Information:
    Title
    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.
    Description
    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.
    Time Frame
    6 month-healing after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    33 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria Paola Cristalli, DDS
    Organizational Affiliation
    University of Roma La Sapienza
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30050947
    Citation
    La Monaca G, Iezzi G, Cristalli MP, Pranno N, Sfasciotti GL, Vozza I. Comparative Histological and Histomorphometric Results of Six Biomaterials Used in Two-Stage Maxillary Sinus Augmentation Model after 6-Month Healing. Biomed Res Int. 2018 Jun 27;2018:9430989. doi: 10.1155/2018/9430989. eCollection 2018.
    Results Reference
    derived

    Learn more about this trial

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

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