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

Guided Bone Regeneration Using Bovine-derived Xenograft in Combination With or Without Injectable Platelet-rich Fibrin: a Randomized-controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Bone Resorption
• Intervention / Treatment: Procedure: bovine-derived xenograft with i-PRF; Procedure: bovine-derived xenograft alone

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: i-PRF enriched bovine-derived xenograft; Patients treated with i-PRF-enriched bovine-derived xenograft + resorbable membrane	Procedure: bovine-derived xenograft with i-PRF; Bovine-derived xenograft was mixed with i-PRF and was placed in the augmentation site.
Experimental: bovine-derived xenograft; Patients treated with bovine-derived xenograft + resorbable membrane	Procedure: bovine-derived xenograft alone; Bovine-derived xenograft was placed in the augmentation site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Augmentation thickness	the change in augmentation thickness at surgical site.	at immediately and at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal bone level	the change in marginal bone level around the implants after prosthetic loading	at immediately, at 6 months, at 12 months and at 24th months

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2017
• Primary Completion (Actual): March 4, 2018
• Study Completion (Actual): November 23, 2020

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 20, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Guided bone regeneration; Bovine-derived xenograft; Injectable platelet-rich fibrin
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: Ege Dentistry School

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No