Socket Preservation Technique Using Bovine Bone, Platelet Rich Fibrin Or A Combination Of Both: A Clinical, Radiographic And Histological Assesment At 4 Months

Ridge Preservation Clinical Trial

Official title:

Socket Preservation Technique Using Bovine Bone, Platelet Rich Fibrin Or A Combination Of Both: A Clinical, Radiographic And Histological Assesment At 4 Months

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05889377
• Other study ID #: XFMD218
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 3, 2021
• Est. completion date: December 20, 2024

Study information

• Verified date: May 2023
• Source: Saint-Joseph University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post extraction alveolar bone resorption is one of the main challenges that face oral implantologists in their daily surgical practice (1). To palliate to post-extraction resorption, advanced bone grafting and regeneration techniques have been described (2). However, these procedures, although well documented and validated, still have relatively high complication rates and patient morbidity, in addition to the elevated cost and duration of treatment (3). Socket preservation is a very useful technique in order to counter post extraction resorption issues, therefore eliminating the need for future complicated and delicate regeneration procedures (4). Many biomaterials were proposed for socket preservation such as allografts and bovine hydroxyapatite (5). Recently autologous platelet concentrates such as Platelet Rich Fibrin PRF were described as a potential socket filler material (6).

In the proposed protocol, fresh extraction sockets will be either grafted by a bovine bone substitute, a PRF plug or a mixture of both. Sockets will then be clinically and radiographically monitored over time to assess three-dimensional soft and hard tissue stability. Bone quality will be histologically examined at 6 months implant placement. A no graft group will serve as control.

The results of this study may be of major importance since they could give an objective idea of the most efficient socket preservation technique, thus offering simple and secure oral rehabilitation solutions for both patient and practitioner.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 62 Years

Eligibility

Inclusion Criteria:

1. Patients will require single tooth extraction and subsequent implant rehabilitation.

2. Patients over 18 years of age.

3. Patients willing to comply with the study requirements (signed consent form)

4. Good oral hygiene and no signs of active periodontal infection

5. No compromising medical status

6. < 10 cigarettes smoking per day

Exclusion Criteria:

1. acute myocardial infarction within the last two months;

2. Uncontrolled coagulation disorders;

3. uncontrolled diabetes (HBA1c> 7.5);

4. radiation therapy to the head \ neck region in the last 24 months;

5. immunocompromised patients, HIV positive or receiving chemotherapy in the last five years;

6. past or present treatment with intravenous bisphosphonates;

7. psychological or psychiatric problems;

8. abuse of alcohol or drugs;

Related Conditions & MeSH terms

• Bone Resorption
• Ridge Preservation

Intervention

Procedure:
• Socket preservation
Socket preservation will be done after tooth extraction. For each group we will use a bone substitute.

Locations

Country	Name	City	State
Lebanon	Saint Joseph University	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hard tissue change by measuring bone profil retraction between 0,4 and 12 months using 3D slicer software	Comparison of the bone profile change by CBCT dicom files superimposition at different time frame	4 and 12 months
Primary	Soft tissue change by measuring gingival retraction between 0,4 and 12 months using 3D slicer sftware	Comparison of the soft tissue profile change by STL files superimposition at different time frame	4 and 12 months