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
About this trial
This is an interventional treatment trial for Bone Substitutes
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
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
NCT ID
NCT04331314
First Posted
March 31, 2020
Last Updated
March 31, 2020
Sponsor
Medical University of Graz
Collaborators
Dentsply Sirona Implants and Consumables
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
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Biphasic Calcium Phosphate vs. Hydroxyapatite in Sinus Floor Elevation
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