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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ridge Preservation; Post Extraction Alveolar Bone Resorption
• Intervention / Treatment: Procedure: Socket preservation

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Saint Joseph University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Bovine Bone	Procedure: Socket preservation; Socket preservation will be done after tooth extraction. For each group we will use a bone substitute.
Experimental: Platelet Rich Fibrin	Procedure: Socket preservation; Socket preservation will be done after tooth extraction. For each group we will use a bone substitute.
Experimental: Bovine Bone + PRF	Procedure: Socket preservation; Socket preservation will be done after tooth extraction. For each group we will use a bone substitute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Saint-Joseph University

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: XFMD218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No