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Status unknownNCT04959513LPRF-GBRUpdated Jul 13, 2021

GBR With L-PRF Bone Block in Early Healing Phase After Extraction

An interventional study of LPRF bone block in Alveolar Ridge Augmentation, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-13.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2021, registered Jun 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

When the practitioners have to place an implant, it is necessary to have a sufficient amount of bone. This study propose to manage clinical situations by an approach using guided bone regeneration using an L-PRF bone block (composite graft composed of a xenograft, a membrane from the patient's blood and a collagenous membrane) after a short healing period of 6 to 8 weeks after tooth extraction. Alveolar ridge changes will be evaluated regarding soft and hard tissues up to 6 months.

Read the detailed description

When the practitioners have to place an implant, it is necessary to have a sufficient amount of bone. After a tooth extraction, a bone remodeling process leads to a resorption of the various sockets components. The spontaneous healing of an extraction may result in an unsuitable site for the implant placement. It is therefore sometimes necessary to perform an alveolar ridge preservation (ARP) at the time of extraction at the future implant site to compensate for this natural resorption. However, some clinical situations don't allow ARP (infection, significant bone loss, etc.) at the time of extraction. In these situations where alveolar preservation is not indicated and bone augmentation is required to recover or preserve correct bone anatomy for implant placement, other techniques must be used. Thus, in this study, the investigators propose to manage these clinical situations by an approach using guided bone regeneration using an L-PRF bone block (composite graft composed of a xenograft, a membrane from the patient's blood and a collagenous membrane) after a short healing period of 6 to 8 weeks after tooth extraction. This early approach allows soft tissue healing (easier primary closure to cover the graft), take advantage of the residual bone architecture of the socket (only at the beginning of its resorption) and allows infection resorption at the extraction site.

The outcomes are the volumetric changes of the soft and hard tissue. To evaluate this volumetric changes, 3 CBCTs and 3 digital impressions will be made at 3 different times: before extraction, before guided bone regeneration and before implant placement (5 to 8 months after regeneration).

Patients will be recruited at Cliniques Universitaires Saint-Luc, participation will be voluntary without any obligation. To be included in the experiment, patients will have to have at least one tooth from the antero-superior sector that must be extracted with the need for pre-implant bone regeneration. This need for guided bone regeneration will be based on a three-dimensional radiological examination.

The chronology of the experiment is :

  1. First consultation to make the diagnosis, explain the experiment and sign the informed consent.
  2. 1st CBCT (Cone Beam Computed Tomography) and 1st digital impression.
  3. Surgery: extraction of tooth(s).
  4. 2nd CBCT, digital impression and control of the healing of the extraction site 10 to 15 days after extraction.
  5. Surgery: Guided bone regeneration 6 to 8 weeks after extraction.
  6. Control of the healing of the site 10 to 14 days after regeneration.
  7. 3rd CBCT, 3rd digital impression 5 to 8 months after regeneration.
  8. Surgery: Implant placement. The data analysis will be done clinically with control visits after the different surgeries and volumetrically with CBCTs and optical impressions. The impressions and the radiographic images will be analysed used dedicated application (MeVisLab for the CBCTs and Gom Inspect for the impressions).
02

Conditions studied

  • Alveolar Ridge Augmentation
03

In context

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • To be over 18 years old.
  • Be in good general health.
  • Have at least one monoradicular tooth (premolar, canine or incisor) that must be extracted with the need for bone regeneration and one or more implants afterwards.
  • Have a DPSI (Dutch Periodontal Screening Index) ≤ 2.

Exclusion criteria

Exclusion Criteria:

  • Being a smoker.
  • Have "active" periodontal problems, have a DPSI > 2.
  • Have a contraindication to the insertion of an implant and/or oral surgery.
  • Have an active inflammatory and/or autoimmune disease of the oral cavity.
  • Treatment with immunosuppressants, corticosteroids or biphosphonates.
  • Have a history of cancer, radiotherapy or chemotherapy for cancer within the last 5 years.
  • Have insulin-dependent diabetes.
  • Have a blood disorder.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    GBR with L-PRF bone block

    Guided bone regeneration using Leukocyte and platelet-rich fibrin

    Procedure: LPRF bone block

Interventions

  • ProcedureLPRF bone block

    Guided bone regeneration using an L-PRF bone block (composite graft composed of a xenograft, a membrane from the patient's blood and a collagenous membrane) after a short healing period of 6 to 8 weeks after tooth extraction

06

What researchers measure

Primary outcomes

  1. Gain in ridge width in millimeters

    Volumetric analysis of hard tissue using CBCT. They will be performed before extraction (T0), before guided bone regeneration (T1) and 6 months after regeneration before implant placement (T2). The CBCT done at T0 will be used as a reference for comparison with the CBCT T1 and T2. A high-resolution scanning protocol will be used with fixed exposure parameters and the CBCT will be adjusted to the target area to allow a significant reduction in irradiation dose. The DICOMs (Digital Imaging and Communication in Medicine) will be analysed using a dedicated application. The images taken at different times will be superimposed with an automatic algorithm and compared by 2D and 3D volumetric measurements.

    Time frame: 5 to 8 month after guided bone regeneration

Secondary outcomes

  1. Volumetric changes of the soft tissue in millimeters

    Volumetric analysis of soft tissue using digital impressions. They will be made before extraction (T0), before guided bone regeneration (T1) and 6 months after regeneration before implant placement (T2). The impressions taken at the different times will be compared in analysis software. Oral-lingual or oral-palatal measurements will be taken in the center of the edentulous site at 1mm, 3mm and 5mm from the gingiva.

    Time frame: 5 to 8 month after guided bone regeneration

  2. Need or not of an additional grafting procedure (yes or no)

    Analyse of the need for further regeneration before the implant is placed.

    Time frame: 5 to 8 month after guided bone regeneration

  3. Analysis of the implant's osseointegration (ISQ)

    An analysis of the osseointegration of the implant using a dedicated device (Osstell IDx, Osstell AB, Göteborg, Sweden).

    Time frame: up to 12 months

  4. Patient reported outcomes mesures (VAS Scale)

    Analysis of the patient's feeling thanks to a "Visual Analog Scale" scale carried out 1 week after the regeneration surgery.

    Time frame: through study completion, an average of 1 year

  5. Occurrence of an adverse effect

    Analysis of the infection rate after regeneration.

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • Clinique Universitaires Saint-Luc
    Brussels, 1200, Belgium
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04959513
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators
Geistlich Pharma AG
Responsible party
Lasserre (Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain) — Principal investigator
First posted
Jul 13, 2021
Start date
Jan 22, 2021
Primary completion
Apr 2022 (estimated)
Completion
Oct 2022 (estimated)
Last update
Jul 13, 2021

Study contacts

Jérôme Lasserre
Contact
jerome.lasserre@uclouvain.be
+3227645719
Jérôme Lasserre
principal investigator · Cliniques universitaires Saint-Luc

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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