Biphasic Calcium Phosphate vs. Hydroxyapatite in Sinus Floor Elevation

Sinus Augmentation Using Symbios Versus Algipore as Bone Graft Material - A Randomized Controlled Clinical Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Sinus Floor Augmentation; Bone Substitutes; Hydroxyapatite; Calcium Phosphates; Rhodophyta
• Intervention / Treatment: Device: Use of Symbios Bone Graft Material; Device: Algipore Bone Substitution Material

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability	measured with Periotest®	12 months after sinus augmentation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate of the implants	Rate of loss of implants	24 months after sinus augmentation
Probing on depth	The measurement of probing depth will be performed with a CPITN probe with 0.5mm ball head	24 months after sinus augmentation
Bleeding on probing		24 months
Crestal bone level after implant	measured by means of single tooth x-rays	12 months after implant placement
Complications	Frequency of complications	6 months after sinus augmentation
Newly formed bone area in mm²	measured through histomorphological analysis	3 months after sinus augmentation
Newly formed bone area in mm²	measured through histomorphological analysis	6 months after sinus augmentation
Old bone area in mm²	measured through histomorphological analysis	3 months after sinus augmentation
Old bone area in mm²	measured through histomorphological analysis	6 months after sinus augmentation
Tissue area in mm²	measured through histomorphological analysis	3 months after sinus augmentation
Tissue area in mm²	measured through histomorphological analysis	6 months after sinus augmentation
Bone substitute area in mm²	measured through histomorphological analysis	3 months after sinus augmentation
Bone substitute area in mm²	measured through histomorphological analysis	6 months after sinus augmentation
New bone infiltration area in bone substitute in mm²	measured through histomorphological analysis	3 months after sinus augmentation
New bone infiltration area in bone substitute in mm²	measured through histomorphological analysis	6 months after sinus augmentation
new bone to bone substitute contact in mm	measured through histomorphological analysis	6 months after sinus augmentation
Penetration depth in mm	measured through histomorphological analysis	3 months after sinus augmentation
Penetration depth in mm	measured through histomorphological analysis	6 months after sinus augmentation

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: Dentsply Sirona Implants
• Investigators: Study Chair: Walther Wegscheider, Prof. DDr., head of department

Publications and helpful links

General Publications

• 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.
• Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 23, 2015
• Primary Completion (ACTUAL): March 20, 2018
• Study Completion (ACTUAL): October 28, 2019

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (ACTUAL): April 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders
• Other Study ID Numbers: 27-224 ex 14/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No