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

Alveolar Ridge Augmentation Clinical Trial

— LPRF-GBR  

Official title:

Alveolar Ridge Augmentation Using GBR With L-PRF Bone Block in Early Healing Phase After Dental Extraction: a Consecutive Case Series

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04959513
• Other study ID #: 2020/19OCT/516
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2021
• Est. completion date: October 2022

Study information

• Verified date: July 2021
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Jérôme Lasserre
• Phone: +3227645719
• Email: jerome.lasserre[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Alveolar Ridge Augmentation

Intervention

Procedure:
• LPRF 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

Locations

Country	Name	City	State
Belgium	Clinique Universitaires Saint-Luc	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Geistlich Pharma AG

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	5 to 8 month after guided bone regeneration
Secondary	Need or not of an additional grafting procedure (yes or no)	Analyse of the need for further regeneration before the implant is placed.	5 to 8 month after guided bone regeneration
Secondary	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).	up to 12 months
Secondary	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.	through study completion, an average of 1 year
Secondary	Occurrence of an adverse effect	Analysis of the infection rate after regeneration.	through study completion, an average of 1 year