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

Sponsor

Ege University (Other)

Overall Status

Completed

CT.gov ID

NCT04709523

Collaborator

(none)

Enrollment

Arms

46.6

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Resorption	Procedure: bovine-derived xenograft with i-PRF Procedure: bovine-derived xenograft alone	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 4, 2017

Actual Primary Completion Date :

Mar 4, 2018

Actual Study Completion Date :

Nov 23, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Augmentation thickness [at immediately and at 6 months]
the change in augmentation thickness at surgical site.

Secondary Outcome Measures

Marginal bone level [at immediately, at 6 months, at 12 months and at 24th months]
the change in marginal bone level around the implants after prosthetic loading

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ege University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gözde Işık, Lecturer, Ege University

ClinicalTrials.gov Identifier:

NCT04709523

Other Study ID Numbers:

Ege Dentistry School

First Posted:

Jan 14, 2021

Last Update Posted:

Feb 23, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gözde Işık, Lecturer, Ege University

Guided bone regeneration

Bovine-derived xenograft

Injectable platelet-rich fibrin

Additional relevant MeSH terms:

Bone Resorption

Study Results

No Results Posted as of Feb 23, 2021