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Bone SubstitutesNCT04331314

Biphasic Calcium Phosphate vs. Hydroxyapatite in Sinus Floor Elevation

A study testing Use of Symbios Bone Graft Material and Algipore Bone Substitution Material in people with Bone Substitutes and Calcium Phosphates, run by Medical University of Graz.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 75 years
What is being tested?
Use of Symbios Bone Graft Material and Algipore Bone Substitution Material
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
23 Feb 2015to 28 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • Patients treated with bisphosphonates
  • Uncontrolled diabetes mellitus
  • Uncontrolled periodontal diseases
  • Smoking
  • Pregnancy

About this study

Official title: 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.

Being tested
Use of Symbios Bone Graft Material, Algipore Bone Substitution Material

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use of Symbios Bone Graft MaterialDevice

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

  • Algipore Bone Substitution MaterialDevice

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

Study groups in NCT04331314
Study groupRoleWhat they receive
SYMBIOS®ExperimentalSinus augmentation with SYMBIOS® Biphasic Bone Graft Material
Receives: Device: Use of Symbios Bone Graft Material
Algipore®Active comparatorSinus augmentation with Algipore® Bone Substitution Material
Receives: Device: Algipore Bone Substitution Material

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implant stability

    measured with Periotest®

    Measured: 12 months after sinus augmentation

Secondary outcomes (18)

  1. Survival rate of the implants

    Rate of loss of implants

    Measured: 24 months after sinus augmentation

  2. Probing on depth

    The measurement of probing depth will be performed with a CPITN probe with 0.5mm ball head

    Measured: 24 months after sinus augmentation

  3. Bleeding on probing

    Measured: 24 months

  4. Crestal bone level after implant

    measured by means of single tooth x-rays

    Measured: 12 months after implant placement

  5. Complications

    Frequency of complications

    Measured: 6 months after sinus augmentation

  6. Newly formed bone area in mm²

    measured through histomorphological analysis

    Measured: 3 months after sinus augmentation

  7. Newly formed bone area in mm²

    measured through histomorphological analysis

    Measured: 6 months after sinus augmentation

  8. Old bone area in mm²

    measured through histomorphological analysis

    Measured: 3 months after sinus augmentation

  9. Old bone area in mm²

    measured through histomorphological analysis

    Measured: 6 months after sinus augmentation

  10. Tissue area in mm²

    measured through histomorphological analysis

    Measured: 3 months after sinus augmentation

  11. Tissue area in mm²

    measured through histomorphological analysis

    Measured: 6 months after sinus augmentation

  12. Bone substitute area in mm²

    measured through histomorphological analysis

    Measured: 3 months after sinus augmentation

  13. Bone substitute area in mm²

    measured through histomorphological analysis

    Measured: 6 months after sinus augmentation

  14. New bone infiltration area in bone substitute in mm²

    measured through histomorphological analysis

    Measured: 3 months after sinus augmentation

  15. New bone infiltration area in bone substitute in mm²

    measured through histomorphological analysis

    Measured: 6 months after sinus augmentation

  16. new bone to bone substitute contact in mm

    measured through histomorphological analysis

    Measured: 6 months after sinus augmentation

  17. Penetration depth in mm

    measured through histomorphological analysis

    Measured: 3 months after sinus augmentation

  18. Penetration depth in mm

    measured through histomorphological analysis

    Measured: 6 months after sinus augmentation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2020
  2. Study start23 Feb 2015
  3. Primary completion20 Mar 2018
  4. Study completion28 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Twenty patients scheduled for lateral-window sinus floor Elevation SFE will be randomized to an HA and a β-TCP/HA Group.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04331314
Sponsor's protocol ID
27-224 ex 14/15
Status last verified
Mar 2020
First submitted
31 Mar 2020
Last updated
2 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 18705811

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

    PubMed 19885448

  • 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.

    PubMed 15015951

  • 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.

    PubMed 16297691

  • 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.

    PubMed 21947545

  • 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.

    PubMed 23714235

  • 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.

    PubMed 30624789

Questions about this trial

What is this clinical trial studying?

A study testing Use of Symbios Bone Graft Material and Algipore Bone Substitution Material in people with Bone Substitutes and Calcium Phosphates, run by Medical University of Graz.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant stability (time frame: 12 months after sinus augmentation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04331314, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.

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