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

Primary Purpose

Ridge Preservation, Post Extraction Alveolar Bone Resorption

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Socket preservation
Sponsored by
Saint-Joseph University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ridge Preservation

Eligibility Criteria

18 Years - 62 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients will require single tooth extraction and subsequent implant rehabilitation. Patients over 18 years of age. Patients willing to comply with the study requirements (signed consent form) Good oral hygiene and no signs of active periodontal infection No compromising medical status < 10 cigarettes smoking per day Exclusion Criteria: acute myocardial infarction within the last two months; Uncontrolled coagulation disorders; uncontrolled diabetes (HBA1c> 7.5); radiation therapy to the head \ neck region in the last 24 months; immunocompromised patients, HIV positive or receiving chemotherapy in the last five years; past or present treatment with intravenous bisphosphonates; psychological or psychiatric problems; abuse of alcohol or drugs;

Sites / Locations

  • Saint Joseph University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Bovine Bone

Platelet Rich Fibrin

Bovine Bone + PRF

Control

Arm Description

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
May 11, 2023
Last Updated
May 25, 2023
Sponsor
Saint-Joseph University
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1. Study Identification

Unique Protocol Identification Number
NCT05889377
Brief Title
Socket Preservation Technique Using Bovine Bone, Platelet Rich Fibrin Or A Combination Of Both: A Clinical, Radiographic And Histological Assesment At 4 Months
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
December 20, 2024 (Anticipated)
Study Completion Date
December 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint-Joseph University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ridge Preservation, Post Extraction Alveolar Bone Resorption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bovine Bone
Arm Type
Experimental
Arm Title
Platelet Rich Fibrin
Arm Type
Experimental
Arm Title
Bovine Bone + PRF
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Socket preservation
Intervention Description
Socket preservation will be done after tooth extraction. For each group we will use a bone substitute.
Primary Outcome Measure Information:
Title
Hard tissue change by measuring bone profil retraction between 0,4 and 12 months using 3D slicer software
Description
Comparison of the bone profile change by CBCT dicom files superimposition at different time frame
Time Frame
4 and 12 months
Title
Soft tissue change by measuring gingival retraction between 0,4 and 12 months using 3D slicer sftware
Description
Comparison of the soft tissue profile change by STL files superimposition at different time frame
Time Frame
4 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients will require single tooth extraction and subsequent implant rehabilitation. Patients over 18 years of age. Patients willing to comply with the study requirements (signed consent form) Good oral hygiene and no signs of active periodontal infection No compromising medical status < 10 cigarettes smoking per day Exclusion Criteria: acute myocardial infarction within the last two months; Uncontrolled coagulation disorders; uncontrolled diabetes (HBA1c> 7.5); radiation therapy to the head \ neck region in the last 24 months; immunocompromised patients, HIV positive or receiving chemotherapy in the last five years; past or present treatment with intravenous bisphosphonates; psychological or psychiatric problems; abuse of alcohol or drugs;
Facility Information:
Facility Name
Saint Joseph University
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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