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Biphasic Calcium Phosphate vs. Hydroxyapatite in Sinus Floor Elevation

Primary Purpose

Bone Substitutes, Calcium Phosphates, Hydroxyapatite

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Use of Symbios Bone Graft Material
Algipore Bone Substitution Material
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Substitutes

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Capability of giving an informed consent
  2. Good health as defined by the subject's medical history
  3. Patients age 20-75 years
  4. Fully edentulous or partially edentulous patients with unilateral or bilateral missing teeth in the maxillary premolar or molar areas with severe alveolar atrophy and a residual alveolar ridge height of maximal 5 mm requiring a two-staged sinus floor elevation and implant placement.

Exclusion Criteria:

  1. Patients without detailed baseline medical data
  2. Patients with medical history of local inflammations in the posterior maxilla
  3. Skeletal immaturity
  4. Patients with osteoporosis in their medical history
  5. Patients with severe illnesses, malignant diseases, radiotherapy or chemotherapy in their medical history
  6. Patients with pathological fractures
  7. Patients treated with bisphosphonates
  8. Uncontrolled diabetes mellitus
  9. Uncontrolled periodontal diseases
  10. Smoking
  11. Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    SYMBIOS®

    Algipore®

    Arm Description

    Sinus augmentation with SYMBIOS® Biphasic Bone Graft Material

    Sinus augmentation with Algipore® Bone Substitution Material

    Outcomes

    Primary Outcome Measures

    Implant stability
    measured with Periotest®

    Secondary Outcome Measures

    Survival rate of the implants
    Rate of loss of implants
    Probing on depth
    The measurement of probing depth will be performed with a CPITN probe with 0.5mm ball head
    Bleeding on probing
    Crestal bone level after implant
    measured by means of single tooth x-rays
    Complications
    Frequency of complications
    Newly formed bone area in mm²
    measured through histomorphological analysis
    Newly formed bone area in mm²
    measured through histomorphological analysis
    Old bone area in mm²
    measured through histomorphological analysis
    Old bone area in mm²
    measured through histomorphological analysis
    Tissue area in mm²
    measured through histomorphological analysis
    Tissue area in mm²
    measured through histomorphological analysis
    Bone substitute area in mm²
    measured through histomorphological analysis
    Bone substitute area in mm²
    measured through histomorphological analysis
    New bone infiltration area in bone substitute in mm²
    measured through histomorphological analysis
    New bone infiltration area in bone substitute in mm²
    measured through histomorphological analysis
    new bone to bone substitute contact in mm
    measured through histomorphological analysis
    Penetration depth in mm
    measured through histomorphological analysis
    Penetration depth in mm
    measured through histomorphological analysis

    Full Information

    First Posted
    March 31, 2020
    Last Updated
    March 31, 2020
    Sponsor
    Medical University of Graz
    Collaborators
    Dentsply Sirona Implants and Consumables
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04331314
    Brief Title
    Biphasic Calcium Phosphate vs. Hydroxyapatite in Sinus Floor Elevation
    Official Title
    Sinus Augmentation Using Symbios Versus Algipore as Bone Graft Material - A Randomized Controlled Clinical Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 23, 2015 (Actual)
    Primary Completion Date
    March 20, 2018 (Actual)
    Study Completion Date
    October 28, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of Graz
    Collaborators
    Dentsply Sirona Implants and Consumables

    4. Oversight

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

    5. Study Description

    Brief Summary
    Twenty patients scheduled for lateral-window sinus floor Elevation (SFE) are randomized into two groups: use of SYMBIOS® Biphasic Bone Graft Material (Group 1) or of Algipore® Bone Substitution Material (Group 2). Biopsies are taken 3 months after SFE and during implant surgery after 6 months. One ground section per biopsy (n=40) is stained, scanned, and histomorphometrically analyzed for new bone, old bone, soft tissue, graft, bone infiltration of graft, bone-to-graft contact, and penetration depth.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Substitutes, Calcium Phosphates, Hydroxyapatite, Rhodophyta, Sinus Floor Augmentation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Twenty patients scheduled for lateral-window sinus floor Elevation SFE will be randomized to an HA and a β-TCP/HA Group.
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SYMBIOS®
    Arm Type
    Experimental
    Arm Description
    Sinus augmentation with SYMBIOS® Biphasic Bone Graft Material
    Arm Title
    Algipore®
    Arm Type
    Active Comparator
    Arm Description
    Sinus augmentation with Algipore® Bone Substitution Material
    Intervention Type
    Device
    Intervention Name(s)
    Use of Symbios Bone Graft Material
    Intervention Description
    Patients will receive Symbios Bone Graft Material according to randomization Group.
    Intervention Type
    Device
    Intervention Name(s)
    Algipore Bone Substitution Material
    Intervention Description
    Patients will receive Algipore Bone Substitution Material according to randomization Group.
    Primary Outcome Measure Information:
    Title
    Implant stability
    Description
    measured with Periotest®
    Time Frame
    12 months after sinus augmentation
    Secondary Outcome Measure Information:
    Title
    Survival rate of the implants
    Description
    Rate of loss of implants
    Time Frame
    24 months after sinus augmentation
    Title
    Probing on depth
    Description
    The measurement of probing depth will be performed with a CPITN probe with 0.5mm ball head
    Time Frame
    24 months after sinus augmentation
    Title
    Bleeding on probing
    Time Frame
    24 months
    Title
    Crestal bone level after implant
    Description
    measured by means of single tooth x-rays
    Time Frame
    12 months after implant placement
    Title
    Complications
    Description
    Frequency of complications
    Time Frame
    6 months after sinus augmentation
    Title
    Newly formed bone area in mm²
    Description
    measured through histomorphological analysis
    Time Frame
    3 months after sinus augmentation
    Title
    Newly formed bone area in mm²
    Description
    measured through histomorphological analysis
    Time Frame
    6 months after sinus augmentation
    Title
    Old bone area in mm²
    Description
    measured through histomorphological analysis
    Time Frame
    3 months after sinus augmentation
    Title
    Old bone area in mm²
    Description
    measured through histomorphological analysis
    Time Frame
    6 months after sinus augmentation
    Title
    Tissue area in mm²
    Description
    measured through histomorphological analysis
    Time Frame
    3 months after sinus augmentation
    Title
    Tissue area in mm²
    Description
    measured through histomorphological analysis
    Time Frame
    6 months after sinus augmentation
    Title
    Bone substitute area in mm²
    Description
    measured through histomorphological analysis
    Time Frame
    3 months after sinus augmentation
    Title
    Bone substitute area in mm²
    Description
    measured through histomorphological analysis
    Time Frame
    6 months after sinus augmentation
    Title
    New bone infiltration area in bone substitute in mm²
    Description
    measured through histomorphological analysis
    Time Frame
    3 months after sinus augmentation
    Title
    New bone infiltration area in bone substitute in mm²
    Description
    measured through histomorphological analysis
    Time Frame
    6 months after sinus augmentation
    Title
    new bone to bone substitute contact in mm
    Description
    measured through histomorphological analysis
    Time Frame
    6 months after sinus augmentation
    Title
    Penetration depth in mm
    Description
    measured through histomorphological analysis
    Time Frame
    3 months after sinus augmentation
    Title
    Penetration depth in mm
    Description
    measured through histomorphological analysis
    Time Frame
    6 months after sinus augmentation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Capability of giving an informed consent Good health as defined by the subject's medical history Patients age 20-75 years Fully edentulous or partially edentulous patients with unilateral or bilateral missing teeth in the maxillary premolar or molar areas with severe alveolar atrophy and a residual alveolar ridge height of maximal 5 mm requiring a two-staged sinus floor elevation and implant placement. Exclusion Criteria: Patients without detailed baseline medical data Patients with medical history of local inflammations in the posterior maxilla Skeletal immaturity Patients with osteoporosis in their medical history Patients with severe illnesses, malignant diseases, radiotherapy or chemotherapy in their medical history Patients with pathological fractures Patients treated with bisphosphonates Uncontrolled diabetes mellitus Uncontrolled periodontal diseases Smoking Pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Walther Wegscheider, Prof. DDr.
    Organizational Affiliation
    Head of Department
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    18705811
    Citation
    Cordaro L, Bosshardt DD, Palattella P, Rao W, Serino G, Chiapasco M. Maxillary sinus grafting with Bio-Oss or Straumann Bone Ceramic: histomorphometric results from a randomized controlled multicenter clinical trial. Clin Oral Implants Res. 2008 Aug;19(8):796-803. doi: 10.1111/j.1600-0501.2008.01565.x.
    Results Reference
    background
    PubMed Identifier
    19885448
    Citation
    Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.
    Results Reference
    background
    PubMed Identifier
    15015951
    Citation
    Schopper C, Moser D, Sabbas A, Lagogiannis G, Spassova E, Konig F, Donath K, Ewers R. The fluorohydroxyapatite (FHA) FRIOS Algipore is a suitable biomaterial for the reconstruction of severely atrophic human maxillae. Clin Oral Implants Res. 2003 Dec;14(6):743-9. doi: 10.1046/j..2003.00959.x.
    Results Reference
    background
    PubMed Identifier
    16297691
    Citation
    Ewers R. Maxilla sinus grafting with marine algae derived bone forming material: a clinical report of long-term results. J Oral Maxillofac Surg. 2005 Dec;63(12):1712-23. doi: 10.1016/j.joms.2005.08.020.
    Results Reference
    background
    PubMed Identifier
    21947545
    Citation
    Scarano A, Degidi M, Perrotti V, Piattelli A, Iezzi G. Sinus augmentation with phycogene hydroxyapatite: histological and histomorphometrical results after 6 months in humans. A case series. Oral Maxillofac Surg. 2012 Mar;16(1):41-5. doi: 10.1007/s10006-011-0296-3. Epub 2011 Sep 24.
    Results Reference
    background
    PubMed Identifier
    23714235
    Citation
    Kuhl S, Payer M, Kirmeier R, Wildburger A, Acham S, Jakse N. The influence of particulated autogenous bone on the early volume stability of maxillary sinus grafts with biphasic calcium phosphate: a randomized clinical trial. Clin Implant Dent Relat Res. 2015 Feb;17(1):173-8. doi: 10.1111/cid.12086. Epub 2013 May 28.
    Results Reference
    background
    PubMed Identifier
    30624789
    Citation
    Raghoebar GM, Onclin P, Boven GC, Vissink A, Meijer HJA. Long-term effectiveness of maxillary sinus floor augmentation: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:307-318. doi: 10.1111/jcpe.13055.
    Results Reference
    background

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    Biphasic Calcium Phosphate vs. Hydroxyapatite in Sinus Floor Elevation

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