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
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
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
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
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