Changes of Soft and Hard Tissues After Alveolar Ridge Preservation: Freeze-dried Bone Allograft vs. L-PRF Clot

April 28, 2020 updated by: Dr. Jonathan Bouwer, University of Manitoba

Dimensional Changes of Soft and Hard Tissues Following Alveolar Ridge Preservation: Freeze-dried Bone Allograft vs. L-PRF Clot Covered With d-PTFE Membrane: A Randomized Clinical Trial

A Clinical Trial to study the effectiveness between two, tooth socket grafting materials namely, Freeze Dried Bone Allograft (human derived bone particles) and Leukocytic-Platelet Rich Fibrin (the patient's own centrifuged blood).

The purpose of this study is to compare the effects (good and bad) of Bone Allograft to Platelet Rich Fibrin to see which material would be the most effective in maintaining the volume of the gum and bone of the jaw during the healing phase as well as minimizing the amount of pain and/or swelling following tooth extraction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective,randomized clinical trial will be conducted to determine whether L-PRF, compared to freeze dried bone allograft, will result in comparable volumetric shrinkage of the alveolar ridge and overlying keratinized tissue, following extraction of teeth and socket grafting.

This trial aims at obtaining information to determine which material would provide a superior clinical result, as well as reporting on patient related outcomes. The participants will be randomly assigned to two groups. The surgical procedure will be performed by one of five calibrated periodontal residents.

Patients will be followed for 2 weeks post-operatively by the same resident, to monitor the healing process and to assess for any complications.

Randomization will be achieved using a computerized randomization scheme and will be assigned to one of two groups and allocated by means of a sealed envelope opened on the day of surgery communicated to the surgeon during the surgery by a supervising faculty member. Participants will be block-randomized for each of the 5 operators for balance.

Anesthesia will be achieved and soft tissue measurements will be obtained using a periodontal probe. An atraumatic extraction technique will be performed to allow for minimal disturbance of the soft and hard tissue architecture.

The extraction socket walls are then assessed and any defects in socket measured with a periodontal probe. Group A: Full thickness mucoperiosteal pouch is created up to ~3mm apical of the bony crest of the socket with a periosteal elevator. The socket is incrementally filled with mineralized cortical freeze-dried bone allograft and condensed. Group B: Socket is pouched as in group A followed by venipuncture of the antecubital vein with 21G needle and collection of 4-6 vials (10ml each) of venous blood without any additive or anticoagulant. The vials are centrifuged for 12 minutes at 2700 rpm to form L-PRF clots. The socket is incrementally filled with the clots and condensed.

Following socket fill, both groups will have the grafts covered by dense polytetrafluoroethylene membrane. The membrane is trimmed and adapted with the borders tucked 2-3mm underneath the gingival tissues. Tissues, graft and membrane are stabilized with 5/0 PTFE sutures.

The patients will also receive a pain VAS questionnaire evaluating the post-operative pain 1 and 7 days following surgery. A CBCT with the radiographic stent will be taken within 72 hours of the surgery.

7 days post-op: Sutures will be removed if deemed suitable. The VAS questionnaire will be collected.

6 weeks post op: d-PTFE membrane will be retrieved and discarded using tissue forceps. Alginate impressions will be taken for a surgical guide.

11 weeks post op: Second CBCT will be taken with radiographic surgical stent. Images obtained will be used to analyze and compare the ridge dimensions to those obtained at baseline as well as for surgical implant planning.

12 weeks post op: Soft tissue measurement with periodontal probe and floss spanned over edentulous site from buccal to lingual mucogingival junction. Implant placement will be done per standard procedure. A 2.5mm diameter trephine drill will be used to harvest a bone core for histologic analysis. The bone core will be immediately submerged in a solution of 10% neutral buffered formalin. Osteotomies and implant placement will be done following the manufacturer's protocol. Depending on the buccal bone and soft tissue thickness, ancillary soft tissue augmentation, bone augmentation or combination of these procedures may be indicated. The patient will be followed up and referred to the restorative dentist as per standard procedure. Photographs will be taken at every visit.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2
  • Phase 3

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

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0W2
        • Graduate Periodontic Clinic - University of Manitoba

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

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with molars or premolars indicated for extraction.
  • Patients that present with a post extraction class I and II socket (<30% bone loss on the buccal or lingual plate, measured from the most coronal aspect of intact bone to the most apical aspect of the defect divided by the measurement from the most apical aspect of the defect to the apex of the socket x 100).
  • Patients presenting with the need for single extractions.
  • Patients with general good health that does not have a condition contra-indicating routine dental treatment, extraction and implant placement.
  • Patients that are compliant with the research protocol and methods.
  • Patients that have read, understood and signed an informed consent form.

Exclusion Criteria:

  • Extraction and ridge preservation indicated for teeth other than premolars and molars.
  • Patients that present with a post extraction class III socket (>30% bone loss on the buccal or lingual plate, measured from the most coronal aspect of intact bone to the most apical aspect of the defect divided by the measurement from the most apical aspect of the defect to the apex of the socket x 100)
  • Patients deemed eligible for immediate implant placement following extraction and intra-operative assessment by the attending supervisor.
  • Patients that present with an oral-antral communication, post extraction.
  • Patients that presents with the need for multiple, side by side extractions.
  • Patients with coagulation disorders, on corticosteroids, uncontrolled diabetes mellitus, or any systemic disease where periodontal surgery is contraindicated and healing may be compromised.
  • Pregnant and nursing women.
  • Patients with any contact hypersensitivity to the related materials used in the study.
  • Heavy tobacco users, >10 cigarettes per day.
  • Patients unwilling to sign consent or follow the protocol of the study.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Freeze Dried Bone Allograft
Socket filled with Mineralized Cortical Freeze Dried Bone Allograft
Biological: Freeze Dried Bone Allograft
Human derived bone particles used in oral and periodontal grafting procedures
Other Names:
  • FDBA
EXPERIMENTAL: L-PRF Clot
Socket filled with L-PRF Clot
Biological: L-PRF clot
L-PRF is a second-generation platelet rich plasma obtained from autologous blood and contains several different growth factors, platelets and leucocytes in a complex fibrin matrix to accelerate the healing of soft and hard tissues.
Other Names:
  • Leukocytic Platelet Rich Fibrin Clot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Horizontal Change in Alveolar Ridge Width
Time Frame: Difference reported on horizontal changes comparing CBCT analysis 11weeks after extraction and grafting compared to CBCT following extraction and grafting
Calculated mean of post operative CBCT measurements of horizontal alveolar bone width changes following extraction and alveolar ridge preservation.
Difference reported on horizontal changes comparing CBCT analysis 11weeks after extraction and grafting compared to CBCT following extraction and grafting

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Buccolingual Change in Width of Keratinized Soft Tissue
Time Frame: Soft tissue measurement at time of extraction and grafting and 12 weeks after extraction and grafting
Difference in post operative measurement analysis of keratinized gingiva changes following extraction and alveolar ridge preservation
Soft tissue measurement at time of extraction and grafting and 12 weeks after extraction and grafting
Post-operative Pain and Swelling
Time Frame: Measured at 7 days following extraction and grafting
Post-operative pain and complications measured by VAS-questionnaire obtained following extraction and grafting. The VAS-questionnaire contained the following categories to be answered 7days post-operatively: Pain, Swelling. A visual line scale of 100mm in length was provided with no pain/swelling on the one end and severe pain/swelling on the opposite end. Participants were instructed to rate their pain and swelling by marking a single line on the scale indicating the degree of pain/swelling they experienced. Markings were physically measured on the scale and converted into a score with 0 representing no pain/swelling and 1 representing severe pain/swelling.
Measured at 7 days following extraction and grafting

Collaborators and Investigators

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

Sponsor

University of Manitoba

Investigators

  • Study Director: Anastasia Cholakis, DDS, University of Manitoba, Faculty of Graduate Studies, Periodontics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 3, 2018

Primary Completion (ACTUAL)

April 2, 2019

Study Completion (ACTUAL)

April 2, 2019

Study Registration Dates

First Submitted

October 27, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (ACTUAL)

November 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2017:125

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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