Vertical GBR LPRF Block vs. Autogenous Bone With DBBM

Alveolar Bone Resorption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06317090
• Other study ID #: S59813-2
• Status: Completed
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Resorption
• Bone Resorption

Intervention

Procedure:
• guided bone regeneration
a non-resorbable membrane was used as a space maintainer, filled with a particulated bone graft.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

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