Biphasic Calcium Phosphate vs. Hydroxyapatite in Sinus Floor Elevation

Sinus Floor Augmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04331314
• Other study ID #: 27-224 ex 14/15
• Status: Completed
• Phase: N/A
• Start date: February 23, 2015
• Est. completion date: October 28, 2019

Study information

• Verified date: March 2020
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 28, 2019
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Substitutes
• Calcium Metabolism Disorders
• Calcium Phosphates
• Hydroxyapatite
• Rhodophyta
• Sinus Floor Augmentation

Intervention

Device:
• Use of Symbios Bone Graft Material
Patients will receive Symbios Bone Graft Material according to randomization Group.
• Algipore Bone Substitution Material
Patients will receive Algipore Bone Substitution Material according to randomization Group.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Dentsply Sirona Implants

References & Publications (7)

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

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. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant stability	measured with Periotest®	12 months after sinus augmentation
Secondary	Survival rate of the implants	Rate of loss of implants	24 months after sinus augmentation
Secondary	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
Secondary	Bleeding on probing		24 months
Secondary	Crestal bone level after implant	measured by means of single tooth x-rays	12 months after implant placement
Secondary	Complications	Frequency of complications	6 months after sinus augmentation
Secondary	Newly formed bone area in mm²	measured through histomorphological analysis	3 months after sinus augmentation
Secondary	Newly formed bone area in mm²	measured through histomorphological analysis	6 months after sinus augmentation
Secondary	Old bone area in mm²	measured through histomorphological analysis	3 months after sinus augmentation
Secondary	Old bone area in mm²	measured through histomorphological analysis	6 months after sinus augmentation
Secondary	Tissue area in mm²	measured through histomorphological analysis	3 months after sinus augmentation
Secondary	Tissue area in mm²	measured through histomorphological analysis	6 months after sinus augmentation
Secondary	Bone substitute area in mm²	measured through histomorphological analysis	3 months after sinus augmentation
Secondary	Bone substitute area in mm²	measured through histomorphological analysis	6 months after sinus augmentation
Secondary	New bone infiltration area in bone substitute in mm²	measured through histomorphological analysis	3 months after sinus augmentation
Secondary	New bone infiltration area in bone substitute in mm²	measured through histomorphological analysis	6 months after sinus augmentation
Secondary	new bone to bone substitute contact in mm	measured through histomorphological analysis	6 months after sinus augmentation
Secondary	Penetration depth in mm	measured through histomorphological analysis	3 months after sinus augmentation
Secondary	Penetration depth in mm	measured through histomorphological analysis	6 months after sinus augmentation