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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

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ClinicalTrials.gov Identifier: NCT04133363
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Nicolaas C. Geurs, DDS, MS, University of Alabama at Birmingham

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Ridge Preservation Procedure: Ridge preservation using L-PRF/FDBA layered technique Procedure: Ridge preservation using L-PRF/FDBA Procedure: Ridge preservation using L-PRF Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2021

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT04133363


Contacts
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Contact: Nicolaas Geurs, DDS, MS 934-1074 ngeurs@uab.edu
Contact: Sarah Startley, DMD 975-8711 ss1971@uab.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35294-0007
Contact: Nicolaas Geurs, DDS,MS    205-934-1074    ngeurs@uab.edu   
Contact: Sarah Startley, DMD    205-975-8711    ss1971@uab.edu   
Sponsors and Collaborators
University of Alabama at Birmingham

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Responsible Party: Nicolaas C. Geurs, DDS, MS, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04133363     History of Changes
Other Study ID Numbers: IRB-300004112
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nicolaas C. Geurs, DDS, MS, University of Alabama at Birmingham:
L-PRF
Bone Allograft
Ridge Preservation
Socket grafting
Bone regeneration