Vertical GBR LPRF Block vs. Autogenous Bone With DBBM

NCT06317090 | Completed

• 1 other identifier: S59813-2
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alveolar Bone Resorption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Buccal bone thickness around the implants

  CBCT scans at placement of the implant and 1 year after loading of the implant

• Buccal bone thickness around the implants

  CBCT scans at 1 year after loading of the implant

• Cumulative survival rate of the implants

  16 months of follow-up

• rates and types of complications

  25 months

Study Arms (2)

Test

EXPERIMENTAL

LPRF block as a grafting material

Procedure: guided bone regeneration

Control

EXPERIMENTAL

50% autogenous bone, 50% DBBM as a grafting material

Procedure: guided bone regeneration

Interventions

guided bone regeneration PROCEDURE

a non-resorbable membrane was used as a space maintainer, filled with a particulated bone graft.

Also known as: GBR

Control; Test

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: neither the patient, nor the outcome assessor was aware at which side which grafting material was used
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Model Details: split-mouth 2 arm RCT

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: March 19, 2024
• Study Start: July 2, 2018
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)