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

NCT04959513 | Unknown DMC

• 1 other identifier: 2020/19OCT/516
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alveolar Ridge Augmentation

Outcome Measures

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.

  5 to 8 month after guided bone regeneration

Secondary Outcomes (5)

• Volumetric changes of the soft tissue in millimeters

  5 to 8 month after guided bone regeneration

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

  5 to 8 month after guided bone regeneration

• Analysis of the implant's osseointegration (ISQ)

  up to 12 months

• Patient reported outcomes mesures (VAS Scale)

  through study completion, an average of 1 year

• Occurrence of an adverse effect

  through study completion, an average of 1 year

Study Arms (1)

GBR with L-PRF bone block

EXPERIMENTAL

Guided bone regeneration using Leukocyte and platelet-rich fibrin

Procedure: LPRF bone block

Interventions

LPRF bone block PROCEDURE

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

GBR with L-PRF bone block

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead
• Geistlich Pharma AG: collaborator

Study Sites (1)

Clinique Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Study Officials

• Jérôme Lasserre

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jérôme Lasserre

CONTACT

+3227645719; jerome.lasserre@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 13, 2021
• Study Start: January 22, 2021
• Primary Completion: April 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)