Guided Bone Regeneration Using Bovine-derived Xenograft in Combination With or Without Injectable Platelet-rich Fibrin
- Conditions
- Bone Resorption
- Interventions
- Procedure: bovine-derived xenograft aloneProcedure: bovine-derived xenograft with i-PRF
- Registration Number
- NCT04709523
- Lead Sponsor
- Ege University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description bovine-derived xenograft bovine-derived xenograft alone Patients treated with bovine-derived xenograft + resorbable membrane i-PRF enriched bovine-derived xenograft bovine-derived xenograft with i-PRF Patients treated with i-PRF-enriched bovine-derived xenograft + resorbable membrane
- Primary Outcome Measures
Name Time Method Augmentation thickness at immediately and at 6 months the change in augmentation thickness at surgical site.
- Secondary Outcome Measures
Name Time Method 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