Skip to main content
OpenTrials
Completed

NCT Number: NCT04331314

Biphasic Calcium Phosphate vs. Hydroxyapatite in Sinus Floor Elevation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bone Substitutes Calcium Phosphates Hydroxyapatite Rhodophyta Sinus Floor Augmentation

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Use of Symbios Bone Graft Material

Device

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

Algipore Bone Substitution Material

Device

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

Primary outcomes

  1. Implant stability

    Time frame: 12 months after sinus augmentation

    measured with Periotest®

Secondary outcomes

  1. Survival rate of the implants

    Time frame: 24 months after sinus augmentation

    Rate of loss of implants

  2. Probing on depth

    Time frame: 24 months after sinus augmentation

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

  3. Bleeding on probing

    Time frame: 24 months

  4. Crestal bone level after implant

    Time frame: 12 months after implant placement

    measured by means of single tooth x-rays

  5. Complications

    Time frame: 6 months after sinus augmentation

    Frequency of complications

  6. Newly formed bone area in mm²

    Time frame: 3 months after sinus augmentation

    measured through histomorphological analysis

  7. Newly formed bone area in mm²

    Time frame: 6 months after sinus augmentation

    measured through histomorphological analysis

  8. Old bone area in mm²

    Time frame: 3 months after sinus augmentation

    measured through histomorphological analysis

  9. Old bone area in mm²

    Time frame: 6 months after sinus augmentation

    measured through histomorphological analysis

  10. Tissue area in mm²

    Time frame: 3 months after sinus augmentation

    measured through histomorphological analysis

  11. Tissue area in mm²

    Time frame: 6 months after sinus augmentation

    measured through histomorphological analysis

  12. Bone substitute area in mm²

    Time frame: 3 months after sinus augmentation

    measured through histomorphological analysis

  13. Bone substitute area in mm²

    Time frame: 6 months after sinus augmentation

    measured through histomorphological analysis

  14. New bone infiltration area in bone substitute in mm²

    Time frame: 3 months after sinus augmentation

    measured through histomorphological analysis

  15. New bone infiltration area in bone substitute in mm²

    Time frame: 6 months after sinus augmentation

    measured through histomorphological analysis

  16. new bone to bone substitute contact in mm

    Time frame: 6 months after sinus augmentation

    measured through histomorphological analysis

  17. Penetration depth in mm

    Time frame: 3 months after sinus augmentation

    measured through histomorphological analysis

  18. Penetration depth in mm

    Time frame: 6 months after sinus augmentation

    measured through histomorphological analysis

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Dentsply Sirona Implants and Consumables

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Apr 2, 2020
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.