LPRF Block vs. DBBM in Horizontal Bone Reconstruction

NCT07584629 | Completed

• 1 other identifier: S59813-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

split-mouth RCT. 12 patients. horizontal GBR performed. 2 grafts were compared: test was LPRF block, control was 50% autogenous bone and 50% DBBM. 25 months follow-up.

Conditions

Alveolar Bone Resorption

Outcome Measures

Primary Outcomes (1)

• bone volume changes

  bone volume is measured on CBCT scans of the jaw

  at intake, immediately after surgery, 9 months postoperative, 13 months postoperative, 25 months postoperative

Secondary Outcomes (3)

• buccal bone thickness on CBCT scan

  measured at placement of the implant and 1 year later

• Cumulative survival rate of the implants

  measured at the 1 year loading follow-up

• Rates of complications

  from the gbr surgery to 25 months follow-up

Study Arms (2)

LPRF block group

EXPERIMENTAL

LPRF block covered by collagen membrane

Procedure: guided bone regeneration

Compound graft group

EXPERIMENTAL

50% autogenous bone with 50% DBBM covered by collagen membrane.

Procedure: guided bone regeneration

Interventions

guided bone regeneration PROCEDURE

Bone grafting procedure using a particulated bone graft, covered by a resorbable membrane

Also known as: GBR, Implant placement after bone healing

Compound graft group; LPRF block group

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: patient was not aware which side received which grafting material Outcome assessor was not awara which side received which grafting material.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Model Details: split-mouth RCT 2 arm

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: May 13, 2026
• Study Start: July 2, 2018
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)