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

Sponsor
Saint-Joseph University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05889377
Collaborator
(none)
80
1
4
37.6
2.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Socket preservation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 3, 2021
Anticipated Primary Completion Date :
Dec 20, 2024
Anticipated Study Completion Date :
Dec 20, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. Hard tissue change by measuring bone profil retraction between 0,4 and 12 months using 3D slicer software [4 and 12 months]

    Comparison of the bone profile change by CBCT dicom files superimposition at different time frame

  2. Soft tissue change by measuring gingival retraction between 0,4 and 12 months using 3D slicer sftware [4 and 12 months]

    Comparison of the soft tissue profile change by STL files superimposition at different time frame

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 62 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Saint Joseph University Beirut Lebanon

Sponsors and Collaborators

  • Saint-Joseph University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christian Makari, Professor, Saint-Joseph University
ClinicalTrials.gov Identifier:
NCT05889377
Other Study ID Numbers:
  • XFMD218
First Posted:
Jun 5, 2023
Last Update Posted:
Jun 5, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 5, 2023