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Completed

NCT Number: NCT07584629

LPRF Block vs. DBBM in Horizontal Bone Reconstruction

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

12 patients were included in this split-mouth RCT. In test sites a horizontal GBR procedure was performed using a collagen membrane with a graft consisting of 50% autogenous bone and 50% DBBM. In control sites a collagen 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guided bone regeneration

Procedure

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

Other names: GBR, Implant placement after bone healing

Primary outcomes

  1. bone volume changes

    Time frame: at intake, immediately after surgery, 9 months postoperative, 13 months postoperative, 25 months postoperative

    bone volume is measured on CBCT scans of the jaw

Secondary outcomes

  1. buccal bone thickness on CBCT scan

    Time frame: measured at placement of the implant and 1 year later

    thickness of the buccal bone plate of the oral implant

  2. Cumulative survival rate of the implants

    Time frame: measured at the 1 year loading follow-up

    survival of the implants over the follow-up time

  3. Rates of complications

    Time frame: from the gbr surgery to 25 months follow-up

    all possible complications were registered and monitored

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Horizontal 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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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