Biphasic Calcium Phosphate vs. Hydroxyapatite in Sinus Floor Elevation

NCT04331314 | Completed

• 1 other identifier: 27-224 ex 14/15
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bone Substitutes; Calcium Phosphates; Hydroxyapatite; Rhodophyta; Sinus Floor Augmentation

Outcome Measures

Primary Outcomes (1)

• Implant stability

  measured with Periotest®

  12 months after sinus augmentation

Secondary Outcomes (18)

• Survival rate of the implants

  24 months after sinus augmentation

• Probing on depth

  24 months after sinus augmentation

• Bleeding on probing

  24 months

• Crestal bone level after implant

  12 months after implant placement

• Complications

  6 months after sinus augmentation

Study Arms (2)

SYMBIOS®

EXPERIMENTAL

Sinus augmentation with SYMBIOS® Biphasic Bone Graft Material

Device: Use of Symbios Bone Graft Material

Algipore®

ACTIVE COMPARATOR

Sinus augmentation with Algipore® Bone Substitution Material

Device: Algipore Bone Substitution Material

Interventions

Use of Symbios Bone Graft Material DEVICE

Patients will receive Symbios Bone Graft Material according to randomization Group.

SYMBIOS®

Algipore Bone Substitution Material DEVICE

Patients will receive Algipore Bone Substitution Material according to randomization Group.

Algipore®

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• Dentsply Sirona Implants and Consumables: collaborator

Related Publications (7)

• 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.

  PMID: 18705811 BACKGROUND

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

  PMID: 19885448 BACKGROUND

• 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.

  PMID: 15015951 BACKGROUND

• 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.

  PMID: 16297691 BACKGROUND

• 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.

  PMID: 21947545 BACKGROUND

• 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.

  PMID: 23714235 BACKGROUND

• 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.

  PMID: 30624789 BACKGROUND

Study Officials

• Walther Wegscheider, Prof. DDr.

  Head of Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Twenty patients scheduled for lateral-window sinus floor Elevation SFE will be randomized to an HA and a β-TCP/HA Group.

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 2, 2020
• Study Start: February 23, 2015
• Primary Completion: March 20, 2018
• Study Completion: October 28, 2019
• Last Updated: April 2, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share