To Compare Ridge Preservation Technique Using Leukocyte Platelet Rich Fibrin (L-PRF) and Freeze-dried Bone Allograft (FDBA) Layered Technique vs L-PRF/FDBA and L-PRF Alone in Influencing Quantity and Quality of New Bone Formation in Grafted Extraction Sockets

August 3, 2023 updated by: Nicolaas C. Geurs, DDS, MS, University of Alabama at Birmingham

Clinical, Radiographic, and Histomorphometric Outcomes Following Ridge Preservation Using Leukocyte Platelet Rich Fibrin (L-PRF) and Freeze-Dried Bone Allograft (FDBA) Layered Technique: A Prospective, Randomized Clinical Trial

This study will evaluate the effect of Leukocyte Platelet Rich Fibrin and freeze-dried bone allograft in a layered technique on the bone quantity and quality following socket grafting in preparation for endosseous implant placement.

Pre (baseline)- and post-grafting (3 months) clinical as well as 2- and 3-dimensional radiographic measurements will be used to evaluate the dimensional ridge changes between sites grafted with L-PRF/FDBA layered technique vs. L-PRF/FDBA and L-PRF alone.

Histological analysis will be performed by a bone biopsy taken at time of surgical re-entry (after 3 months) of grafted sites to place the dental implant and assessed for differences in new bone formation between the three types of graft.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, three-arm randomized trial that will evaluate and compare the bone healing following ridge preservation of extraction sockets using either L-PRF/FDBA layered technique or L-PRF/FDBA or L-PRF alone in a total of 30 patients (10 in each arm).

Qualifying participants and defects will be randomized following a computerized permutation block to receive either technique on day of surgery. Tooth extraction will be performed with a flapless minimally invasive technique, followed by socket grafting with a randomized graft.

The mineralized cortico-cancellous bone allograft that will be used in this study will be obtained from the same donor, lot and tissue bank to account for variation in age, race, gender and related healing potential of different graft sources.

Bone core biopsies will be harvested at time of implant placement 3 months following socket grafting. Bone cores will then undergo histological and histomorphometrical analyses to determine qualitative and quantitative healing differences between three treatment groups.

Clinical measurements are gathered at 2 time points (grating and implant placement) at all defects and will be compared for differences.

Cone beam computed tomography (CBCT) initial scans are conducted immediately following socket grafting and second scans obtained prior to implant placement. Virtual implant planning software will be utilized to assess and compare the 2- and 3-dimensional changes for all defects.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0007
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • English speaking and able to read and understand English informed consent document
  • At least 18 years old.
  • Must be a patient at the UAB School of Dentistry
  • Patient is willing and able to comply with all steps of the study
  • Hopeless single-rooted tooth planned to be replaced with a dental implant and with healthy adjacent teeth not planned for extraction.

Exclusion Criteria:

  • Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
  • Pregnant women
  • Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ridge preservation using L-PRF/ FDBA Layered
Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA layered technique
Procedure: Ridge preservation using L-PRF/FDBA layered technique
Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA layered technique
Experimental: Ridge preservation using L-PRF/ FDBA
Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA
Procedure: Ridge preservation using L-PRF/FDBA
Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA
Experimental: Ridge preservation using L-PRF
Atraumatic tooth extraction following by socket grafting using L-PRF alone
Procedure: Ridge preservation using L-PRF
Atraumatic tooth extraction following by socket grafting using L-PRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurements of clinical dimensional changes at alveolar ridge 3 months after ridge preservation procedure using L-PRF alone, L-PRF/FDBA, and L-PRF/FDBA layered technique
Time Frame: From baseline to 3 months
Compare quantitative clinical alveolar ridge dimensions (in mm) 3 months after ridge preservation between the three groups using an intraoral scan and direct clinical assessment. Clinically we will measure the bone width of the ridge at time of extraction and after three months during the implant placement procedure. The dimensional changes will be calculated by subtracting the follow measurement from the initial measurement.
From baseline to 3 months
Measurements of the radiographic dimensional changes at alveolar ridge 3 months after ridge preservation procedure using L-PRF alone, L-PRF/FDBA, and L-PRF/FDBA layered technique
Time Frame: From baseline to 3 months
Compare quantitative clinical and radiographic alveolar ridge dimensions (in mm) 3 months after ridge preservation between the three groups using a CBCT scan and implant planning software. The bone width at the extraction site will be measured on the CBCT taken directly after the extraction. The same measurement will be taken at the 3 month follow up CBCT. The dimensional changes will be calculated by subtracting the follow measurement from the initial measurement. In addition the two CBCT's will be overplayed and using specialized software we will measure the change in bone width at the various aspects of the site, lingual mesial buccal and distal.
From baseline to 3 months
Quantitative and qualitative assessments of the histology of the bone harvested at the 3 month visit.
Time Frame: From baseline to 3 months
Compare quantitative and qualitative histologic characteristics of new bone between the three groups after 3 months of ridge preservation by quantifying the distribution (in %) of new vital bone, connective tissue, residual graft particles, and artifact at the healed socket site. Using specialized software the distribution of new bone, redial graft and other tissues will be quantitated. The quality of the bone created will analyzed using a descriptive analysis.
From baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

October 27, 2021

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

October 17, 2019

First Submitted That Met QC Criteria

October 17, 2019

First Posted (Actual)

October 21, 2019

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-300004112

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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