Clinical trial NCT04331314: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bone Substitutes
Calcium Phosphates
Hydroxyapatite
Rhodophyta
Sinus Floor Augmentation
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Dentsply Sirona Implants and Consumables
First posted: 2020-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Twenty patients scheduled for lateral-window sinus floor Elevation SFE will be randomized to an HA and a β-TCP/HA Group.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Implant stability
timeFrame: 12 months after sinus augmentation
Secondary outcomes:
measure: Survival rate of the implants
timeFrame: 24 months after sinus augmentation
measure: Probing on depth
timeFrame: 24 months after sinus augmentation
measure: Bleeding on probing
timeFrame: 24 months
measure: Crestal bone level after implant
timeFrame: 12 months after implant placement
measure: Complications
timeFrame: 6 months after sinus augmentation
measure: Newly formed bone area in mm²
timeFrame: 3 months after sinus augmentation
measure: Newly formed bone area in mm²
timeFrame: 6 months after sinus augmentation
measure: Old bone area in mm²
timeFrame: 3 months after sinus augmentation
measure: Old bone area in mm²
timeFrame: 6 months after sinus augmentation
measure: Tissue area in mm²
timeFrame: 3 months after sinus augmentation
measure: Tissue area in mm²
timeFrame: 6 months after sinus augmentation
measure: Bone substitute area in mm²
timeFrame: 3 months after sinus augmentation
measure: Bone substitute area in mm²
timeFrame: 6 months after sinus augmentation
measure: New bone infiltration area in bone substitute in mm²
timeFrame: 3 months after sinus augmentation
measure: New bone infiltration area in bone substitute in mm²
timeFrame: 6 months after sinus augmentation
measure: new bone to bone substitute contact in mm
timeFrame: 6 months after sinus augmentation
measure: Penetration depth in mm
timeFrame: 3 months after sinus augmentation
measure: Penetration depth in mm
timeFrame: 6 months after sinus augmentation
Other outcomes:
Locations:
Study officials:
affiliation: Head of Department
name: Walther Wegscheider, Prof. DDr.
role: STUDY_CHAIR
References:
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.
citation: Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.
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.
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.
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.
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.
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.