Bovine-derived Xenograft With or Without L-PRF for Alveolar Ridge Preservation After Tooth Extraction: a Randomized Controlled Trial

Bovine-derived Xenograft (Bio-Oss Collagen) With or Without Leukocyte-platelet Rich Fibrin (L-PRF) for Alveolar Ridge Preservation After Tooth Extraction: a Randomized Controlled Trial

The study is prospective randomized clinical trial that aims to evaluate the adjunctive use of L-PRF in promoting the desired vascularization and bone fill in small and large defects following tooth extraction and report on the long-term implant and patient outcomes

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Implants; Bone Regeneration; Tooth Extraction
• Intervention / Treatment: Procedure: Alveolar ridge preservation using sticky bone

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Aged 18 or over.
• Require extraction of anterior or posterior single tooth due to caries, endodontic and prosthetic complications.
• The tooth that requires extraction is bordered by two teeth.
• Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline).
• Good compliance and commitment to attend follow-up review appointments.
• Willing to provide informed consent.

Exclusion Criteria:

• Localised / generalised periodontitis.
• Presence of acute periapical lesion.
• Bone metabolic disease and/or taking medications that affect bone metabolism.
• Long term use of non-steroidal anti-inflammatory medications.
• History of malignancy, radiotherapy or chemotherapy.
• Pregnant or lactating women.
• Severe bruxism or parafunctional habits.
• Large occlusal discrepancies.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group (C); Xenograft + resorbable collagen membrane	Procedure: Alveolar ridge preservation using sticky bone; In the test group the xenograft will be mixed in with the L-PRF then placed into the socket.
Experimental: Test group (T); Xenograft combined with L-PRF + resorbable collagen membrane	Procedure: Alveolar ridge preservation using sticky bone; In the test group the xenograft will be mixed in with the L-PRF then placed into the socket.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival / success rate will be assessed clinically after one year of implant restoration and annually up to three years.		2 years
Patient postoperative experience will be assessed using visual analogue scale during the first week following tooth extraction and ridge preservation.	Reporting a score will be done using the pain visual analogue scale. Minimum value is 0 which is no pain and maximum value is 10 which is the worst pain ever experienced.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in width and height of alveolar ridge will be assessed at the time of tooth extraction and ridge preservation, six months (prior to implant placement) and annually up to two years using cone beam computed tomography (CBCT).	2 years
Need for additional bone augmentation will only be assessed at the time of implant placement by recording the use of bone graft (if required) in the clinical notes.	2 years
Changes in peri-implant marginal bone level will be assessed at implant placement (baseline) and after one year of implant restoration and annually up to two years using standardized peri-apical radiograph.	2 years
Soft tissue levels (midbuccal marginal tissue level changes, interproximal papilla level changes and changes in width of keratinised tissue) will be assessed at implant placement (baseline), at 1 year and at 2 years	2 years
Biological complications (i.e. peri-implant diseases) will be assessed clinically using periodontal probe after one year of implant restoration and annually up to two years.	2 years

Collaborators and Investigators

• Sponsor: Mohammed Bin Rashid University of Medicine and Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2024
• Primary Completion (Estimated): December 9, 2025
• Study Completion (Estimated): December 9, 2025

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MBRU-PRF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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