Alveolar Ridge Augmentation Following Tooth Extraction Using Bovine Xenograft With Platelet Rich Fibrin Membrane

fourteen patients requiring extraction of one posterior tooth with lost buccal bone (>50%) confirmed preoperatively by Cone-beam computed tomography (CBCT) scans. Extraction sockets were filled with minced PRF clots mixed with the bovine xenograft and covered by PRF membranes to seal the extraction sockets. (CBCT) scans, performed before tooth extraction and after 6 months, were used to assess vertical and horizontal bone changes.

Study Overview

• Status: Completed
• Conditions: Bone Regeneration
• Intervention / Treatment: Procedure: a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Future University in Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients required implant treatment after tooth extraction
• Age group ranged from 20-60 years old.
• Patients could undergo the treatment under local anesthesia.
• Loss of buccal bone (>50%) confirmed by preoperative cone beam computed tomography (CBCT).
• Presence of other socket walls; mesial, distal and lingual walls.
• Tooth needed to be extracted in upper or lower posterior regions

Exclusion Criteria:

• Uncontrolled diabetic diseases.
• Uncontrolled hypertension, or hepatic and renal disorders.
• Any systemic diseases associated with bone metabolism.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket	Procedure: a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket; Extraction sockets were filled with minced PRF clots mixed with the bovine xenograft and covered by PRF membranes to seal the extraction sockets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change in alveolar bone width and height in mm using CBCT scans.	Cone Beam Computed Tomography were taken for each patients before tooth extraction and after 6 months, which were used to assess alveolar ridge changes in width and length in mm.	6 months

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2018
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): March 5, 2023

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: REC-FDBSU/05012023-03/ER

Drug and device information, study documents

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