Vertical GBR LPRF Block vs. Autogenous Bone With DBBM

Vertical Guided Bone Regeneration: LPRF Block vs a Mixture of Autogenous Bone With Deproteinized Bovine Bone Mineral. A Split-mouth RCT Study With 25 Months Follow-up

split-mouth RCT, 25 months follow up. GBR protocol with LPRF as grafting material in the test group and autogenous bone with DBBM as grafting material in the control group.

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Resorption
• Intervention / Treatment: Procedure: guided bone regeneration

Detailed Description

6 patients were included in this split-mouth RCT. In control sites a horizontal GBR procedure was performed using a titanium reinforced dPTFE membrane with a graft consisting of 50% autogenous bone and 50% DBBM. In test sites a titanium reinforced dPTFE membrane was used, with a graft consisting of an LPRF block. This was left to heal for 9 months. Subsequently an implant was placed. At time of implant placement a bone biopsy was taken. After 4 months of osseointegration the abutment connection was performed. 1 year after loading of the implants a final check was done. CBCT scans were taken at intake, immediately after reconstruction, 9 months after reconstruction, before implant placement and 1 year after loading of the implants.

Primary outcome measure is the bone volume as measured on the CBCT scans. Secondary outcome measures are bone quality in the biopsy, buccal bone thickness around the oral implant, number and type of complications, cumulative survival rates of the implants 1 year after loading.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Males or females, with ASA I or II, between 18 and 80 years old
• 2 implant sites requiring vertical bone augmentation prior to implant placement
• Both sites in the same jaw
• Good general health as documented by self-assessment

Exclusion Criteria:

• Any systemic medical condition that could interfere with the surgical procedure, planned treatment or healing of the patient
• Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.
• Current pregnancy or breast feeding/ lactating at the time of recruitment.
• Radiotherapy or Chemotherapy in head and neck area.
• Intravenous and oral bisphosphonate therapy.
• Smoking
• Unwillingness to return for the follow-up examination.
• Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unrealistic expectations
• Presence of osseous pathologies, that might interfere with normal wound healing
• Presence of oral lesions (such as ulceration, malignancy)
• Local inflammation, including untreated periodontitis
• Patients with inadequate oral hygiene or unmotivated for adequate home care

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; LPRF block as a grafting material	Procedure: guided bone regeneration; a non-resorbable membrane was used as a space maintainer, filled with a particulated bone graft.; Other Names: GBR
Experimental: Control; 50% autogenous bone, 50% DBBM as a grafting material	Procedure: guided bone regeneration; a non-resorbable membrane was used as a space maintainer, filled with a particulated bone graft.; Other Names: GBR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone volume as measured on CBCT scans	CBCT scans taken and software used for measurement	CBCT scans at intake, with follow-up until 25 months post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Buccal bone thickness around the implants	Bone thickness measured on CBCT scans	CBCT scans at placement of the implant and 1 year after loading of the implant
Buccal bone thickness around the implants	Bone thickness measured on CBCT scans	CBCT scans at 1 year after loading of the implant
Cumulative survival rate of the implants	Implants followed for 1 year after loading and survival recorded	16 months of follow-up
rates and types of complications	All complications recorded during 25 months follow-up	25 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2018
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: S59813-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: all info available on request

Drug and device information, study documents

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