Biphasic Calcium Phosphate vs. Hydroxyapatite in Sinus Floor Elevation
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SYMBIOS® Sinus augmentation with SYMBIOS® Biphasic Bone Graft Material |
Device: Use of Symbios Bone Graft Material
Patients will receive Symbios Bone Graft Material according to randomization Group.
|
| Active Comparator: Algipore® Sinus augmentation with Algipore® Bone Substitution Material |
Device: Algipore Bone Substitution Material
Patients will receive Algipore Bone Substitution Material according to randomization Group.
|
Outcome Measures
Primary Outcome Measures
- Implant stability [12 months after sinus augmentation]
measured with Periotest®
Secondary Outcome Measures
- Survival rate of the implants [24 months after sinus augmentation]
Rate of loss of implants
- Probing on depth [24 months after sinus augmentation]
The measurement of probing depth will be performed with a CPITN probe with 0.5mm ball head
- Bleeding on probing [24 months]
- Crestal bone level after implant [12 months after implant placement]
measured by means of single tooth x-rays
- Complications [6 months after sinus augmentation]
Frequency of complications
- Newly formed bone area in mm² [3 months after sinus augmentation]
measured through histomorphological analysis
- Newly formed bone area in mm² [6 months after sinus augmentation]
measured through histomorphological analysis
- Old bone area in mm² [3 months after sinus augmentation]
measured through histomorphological analysis
- Old bone area in mm² [6 months after sinus augmentation]
measured through histomorphological analysis
- Tissue area in mm² [3 months after sinus augmentation]
measured through histomorphological analysis
- Tissue area in mm² [6 months after sinus augmentation]
measured through histomorphological analysis
- Bone substitute area in mm² [3 months after sinus augmentation]
measured through histomorphological analysis
- Bone substitute area in mm² [6 months after sinus augmentation]
measured through histomorphological analysis
- New bone infiltration area in bone substitute in mm² [3 months after sinus augmentation]
measured through histomorphological analysis
- New bone infiltration area in bone substitute in mm² [6 months after sinus augmentation]
measured through histomorphological analysis
- new bone to bone substitute contact in mm [6 months after sinus augmentation]
measured through histomorphological analysis
- Penetration depth in mm [3 months after sinus augmentation]
measured through histomorphological analysis
- Penetration depth in mm [6 months after sinus augmentation]
measured through histomorphological analysis
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medical University of Graz
- Dentsply Sirona Implants
Investigators
- Study Chair: Walther Wegscheider, Prof. DDr., Head of Department
Study Documents (Full-Text)
None provided.More Information
Publications
- Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59. Review.
- 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.
- 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.
- Kühl 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.
- 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.
- 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.
- Schopper C, Moser D, Sabbas A, Lagogiannis G, Spassova E, König 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.
- 27-224 ex 14/15