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Completed

NCT Number: NCT06317090

Vertical GBR LPRF Block vs. Autogenous Bone With DBBM

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.

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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

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.

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

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

Other names: GBR

Primary outcomes

  1. bone volume as measured on CBCT scans

    Time frame: CBCT scans at intake, with follow-up until 25 months post-operative

    CBCT scans taken and software used for measurement

Secondary outcomes

  1. Buccal bone thickness around the implants

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

    Bone thickness measured on CBCT scans

  2. Buccal bone thickness around the implants

    Time frame: CBCT scans at 1 year after loading of the implant

    Bone thickness measured on CBCT scans

  3. Cumulative survival rate of the implants

    Time frame: 16 months of follow-up

    Implants followed for 1 year after loading and survival recorded

  4. rates and types of complications

    Time frame: 25 months

    All complications recorded during 25 months follow-up

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Mar 19, 2024
Registry last updated
Mar 19, 2024

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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