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Comparison of Phicogenic vs. Xenogeneic Biomaterial for Maxillary Sinus Floor Elevation

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ClinicalTrials.gov Identifier: NCT03682315
Recruitment Status : Completed
First Posted : September 24, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Pablo Galindo-Moreno, Universidad de Granada

Brief Summary:

The study aims to evaluate the clinical and radiological behavior, the histological and morphometrical components, the expression of proteins related to bone formation, and the analysis of markers of reparative mesenchymal stromal cells, after using a biphasic phicogenic biomaterial in comparison with anorganic bovine bone.

A randomized split-mouth clinical study is designed to include patients in need of two-stage bilateral maxillary sinus floor elevation. Patients are assigned to receive a mix of autogenous bone and a biphasic phycogenic biomaterial in one maxillary sinus and a mix of autogenous bone and xenograft bovine hydroxyapatite in the other maxillary sinus. Cone-beam computerized tomography (CBCT) scans are performed before sinus floor elevation and 6 months after the procedure to assess the bone gain. Bone core biopsies are obtained at the site of implant placement 6 months after the floor elevation. Histological sections are subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.


Condition or disease Intervention/treatment Phase
Sinus Floor Augmentation Device: Biphasic phycogenic biomaterial Device: Xenograft bovine hydroxyapatite Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Algae-derived Hydroxyapatite Behaviour as Bone Biomaterial in Comparison to Anorganic Bovine Bone. A Randomised Split-mouth Human Study.
Actual Study Start Date : September 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Durapatite

Arm Intervention/treatment
Active Comparator: Biphasic phycogenic biomaterial
Biphasic phycogenic biomaterial and Autogenous cortical bone
Device: Biphasic phycogenic biomaterial
Maxillary sinus floor elevation and bone grafting with the use of biphasic phycogenic biomaterial combined with autogenous cortical bone

Experimental: Xenograft bovine hydroxyapatite
Xenograft bovine hydroxyapatite and Autogenous cortical bone
Device: Xenograft bovine hydroxyapatite
Maxillary sinus floor elevation and bone grafting with the use of xenograft bovine hydroxyapatite combined with autogenous cortical bone




Primary Outcome Measures :
  1. Sinus floor height change [ Time Frame: From surgery to 6 months ]
    CBCT scans are performed before the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change from the crestal bone to the floor of the maxillary sinus


Secondary Outcome Measures :
  1. Area of new mineralized tissue [ Time Frame: 6 months ]
    Histomorphometric quantification of new mineralized tissue in a bone biopsy collected 6 months after the grafting procedure

  2. Area of non-mineralized tissue [ Time Frame: 6 months ]
    Histomorphometric quantification of non-mineralized tissue in a bone biopsy collected 6 months after the grafting procedure

  3. Area of remaining graft particles [ Time Frame: 6 months ]
    Histomorphometric quantification of remaining graft particles in a bone biopsy collected 6 months after the grafting procedure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Partially edentulous patients.
  • Kennedy class I in the upper jaw.
  • Less than 5 mm of residual crestal bone to the maxillary sinus.
  • Need for the replacement of teeth with dental implants.

Exclusion Criteria:

  • Sinus pathology (sinusitis, mucocele, cysts).
  • Smokers.
  • Previous long-term (>3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682315


Locations
Spain
Facultad de Odontología
Granada, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
Investigators
Principal Investigator: Pablo Galindo-Moreno, DDS, PhD, MS Universidad de Granada

Publications:
Responsible Party: Pablo Galindo-Moreno, Full Professor of Oral Surgery and Implant Dentistry, Universidad de Granada
ClinicalTrials.gov Identifier: NCT03682315     History of Changes
Other Study ID Numbers: 307CEIH2017
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pablo Galindo-Moreno, Universidad de Granada:
Maxillary sinus augmentation
Sinus lift
Biomaterial
Anorganic bovine bone
Phicogenic biomaterial
Implant Dentistry