search
Back to results

Guided Bone Regeneration Using Bovine-derived Xenograft in Combination With or Without Injectable Platelet-rich Fibrin

Primary Purpose

Bone Resorption

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bovine-derived xenograft with i-PRF
bovine-derived xenograft alone
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Resorption focused on measuring Guided bone regeneration, Bovine-derived xenograft, Injectable platelet-rich fibrin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • horizontal deficiency of the alveolar bone in the posterior regions of mandible
  • absence of periodontal disease or previously treated
  • with blood tests showing platelet counts at least 150.000 mm3
  • ability to understand and accept the requirements of the study.

Exclusion Criteria:

  • any disorders or infection at the implantation site or adjacent tissue
  • tooth loss or extraction in the planned implant site within 6 months
  • poor oral hygiene
  • medical conditions that compromised tissue healing (uncontrolled diabetes, etc.)
  • treatments with an interfering medications (bisphosphonates, steroids etc.)
  • smoking habit
  • pregnancy or nursing

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    i-PRF enriched bovine-derived xenograft

    bovine-derived xenograft

    Arm Description

    Patients treated with i-PRF-enriched bovine-derived xenograft + resorbable membrane

    Patients treated with bovine-derived xenograft + resorbable membrane

    Outcomes

    Primary Outcome Measures

    Augmentation thickness
    the change in augmentation thickness at surgical site.

    Secondary Outcome Measures

    Marginal bone level
    the change in marginal bone level around the implants after prosthetic loading

    Full Information

    First Posted
    January 13, 2021
    Last Updated
    February 20, 2021
    Sponsor
    Ege University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04709523
    Brief Title
    Guided Bone Regeneration Using Bovine-derived Xenograft in Combination With or Without Injectable Platelet-rich Fibrin
    Official Title
    Guided Bone Regeneration Using Bovine-derived Xenograft in Combination With or Without Injectable Platelet-rich Fibrin: a Randomized-controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 4, 2017 (Actual)
    Primary Completion Date
    March 4, 2018 (Actual)
    Study Completion Date
    November 23, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ege University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the study was to compare the change in augmentation thickness after guided bone regeneration (GBR) using bovine-derived xenograft in combination with or without injectable platelet-rich fibrin (i-PRF). This randomized-controlled clinical trial was conducted on patients with horizontal bone deficiency in the posterior regions of mandible. After implant placement, GBR procedures were randomly performed using i-PRF enriched bovine-derived xenograft (test group) or bovine derived xenograft alone (control group). Cone-beam computed tomography was taken at the implant sites immediately, and 6 months after surgery for assess the change in augmentation thickness as the primary outcome of the study. The secondary outcomes included marginal bone level and implant survival rate.
    Detailed Description
    The study was conducted on patients who had partially edentulism with horizontal deficiency of the alveolar bone in the posterior regions of mandible. All patients were informed about treatment protocol of the study and also, the risks and benefits associated with participation. Each patient provided written informed consent prior to enrollment. Randomization was performed after the dental implant surgeries and the patients were randomly assigned to one of the study groups: Test group included 22 patients treated with GBR using i-PRF-enriched bovine-derived xenograft + resorbable membrane Control group included 22 patients treated with GBR using bovine-derived xenograft + resorbable membrane All patients underwent two-stage surgical protocol that performed by the same experienced surgeon. Following implant placement, i-PRF-enriched bovine-derived xenograft for the test group and bovine-derived xenograft alone for the control group was carefully positioned with light compression around the implants. Finally, the resorbable membrane was placed to cover the augmented area. As the second stage of surgery, healing caps were placed and the implant-supported fixed prosthesis were completed in approximately one to two months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Resorption
    Keywords
    Guided bone regeneration, Bovine-derived xenograft, Injectable platelet-rich fibrin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    i-PRF enriched bovine-derived xenograft
    Arm Type
    Experimental
    Arm Description
    Patients treated with i-PRF-enriched bovine-derived xenograft + resorbable membrane
    Arm Title
    bovine-derived xenograft
    Arm Type
    Experimental
    Arm Description
    Patients treated with bovine-derived xenograft + resorbable membrane
    Intervention Type
    Procedure
    Intervention Name(s)
    bovine-derived xenograft with i-PRF
    Intervention Description
    Bovine-derived xenograft was mixed with i-PRF and was placed in the augmentation site.
    Intervention Type
    Procedure
    Intervention Name(s)
    bovine-derived xenograft alone
    Intervention Description
    Bovine-derived xenograft was placed in the augmentation site.
    Primary Outcome Measure Information:
    Title
    Augmentation thickness
    Description
    the change in augmentation thickness at surgical site.
    Time Frame
    at immediately and at 6 months
    Secondary Outcome Measure Information:
    Title
    Marginal bone level
    Description
    the change in marginal bone level around the implants after prosthetic loading
    Time Frame
    at immediately, at 6 months, at 12 months and at 24th months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: horizontal deficiency of the alveolar bone in the posterior regions of mandible absence of periodontal disease or previously treated with blood tests showing platelet counts at least 150.000 mm3 ability to understand and accept the requirements of the study. Exclusion Criteria: any disorders or infection at the implantation site or adjacent tissue tooth loss or extraction in the planned implant site within 6 months poor oral hygiene medical conditions that compromised tissue healing (uncontrolled diabetes, etc.) treatments with an interfering medications (bisphosphonates, steroids etc.) smoking habit pregnancy or nursing

    12. IPD Sharing Statement

    Learn more about this trial

    Guided Bone Regeneration Using Bovine-derived Xenograft in Combination With or Without Injectable Platelet-rich Fibrin

    We'll reach out to this number within 24 hrs