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

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ClinicalTrials.gov Identifier: NCT03331185
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Jonathan Bouwer, University of Manitoba

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Alveolar Bone Loss Tooth Loss Biological: Freeze Dried Bone Allograft Biological: L-PRF clot Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective,randomized clinical trial will be conducted. The trial aims at obtaining information to determine which material would provide a superior clinical result, as well as reporting on patient related outcomes. 42 participants will be randomly assigned to two groups and a direct comparison will be made between the results obtained from the two groups.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Volumetric 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
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : July 1, 2019

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 Name: 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 Name: Leukocytic Platelet Rich Fibrin Clot




Primary Outcome Measures :
  1. Volumetric Changes of Hard Tissue [ Time Frame: CBCT analysis within 72hours following extraction and grafting, CBCT analysis 11weeks after extraction and grafting ]
    Post operative volumetric CBCT analysis of alveolar bone changes following extraction and alveolar ridge preservation


Secondary Outcome Measures :
  1. Volumetric Changes of Soft Tissue [ Time Frame: Soft tissue measurement at time of extraction and grafting and 12 weeks after extraction and grafting ]
    Post operative volumetric analysis of keratinized gingiva changes following extraction and alveolar ridge preservation

  2. Post-operative pain and complications [ Time Frame: Measured at 1 and 7 days following extraction and grafting ]
    Post-operative pain and complications measured by VAS-questionnaire obtained following extraction and grafting



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331185


Contacts
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Contact: Jonathan Bouwer, DDS 2048981132 jfbouwer@gmail.com
Contact: John Tsourounakis, DDS 2042920730 itsourou@gmail.com

Locations
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Canada, Manitoba
Graduate Periodontic Clinic - University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0W2
Contact: Shelley Rempel-Rossum    2047893389    shelley.rempel-rossum@umanitoba.ca   
Principal Investigator: Jonathan Bouwer, DDS         
Sponsors and Collaborators
University of Manitoba
Investigators
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Study Director: Anastasia Cholakis, DDS University of Manitoba, Faculty of Graduate Studies, Periodontics

Publications:

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Responsible Party: Dr. Jonathan Bouwer, Periodontal Resident, University of Manitoba
ClinicalTrials.gov Identifier: NCT03331185     History of Changes
Other Study ID Numbers: B2017:125
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Dr. Jonathan Bouwer, University of Manitoba:
Extraction
Alveolar Ridge Augmentation
Freeze Dried Bone Allograft
Leukocytic Platelet Rich Fibrin
Volumetric Changes
Dense Polytetrafluoroethylene Membrane

Additional relevant MeSH terms:
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Alveolar Bone Loss
Tooth Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases