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Completed

NCT Number: NCT04133363

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

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.

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Key information

Conditions

Ridge Preservation

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0007, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ridge preservation using L-PRF/FDBA layered technique

Procedure

Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA layered technique

Ridge preservation using L-PRF/FDBA

Procedure

Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA

Ridge preservation using L-PRF

Procedure

Atraumatic tooth extraction following by socket grafting using L-PRF

Primary outcomes

  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. 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 radiographic alveolar ridge dimensions (in mm) 3 months after ridge preservation between the three groups using a CBCT scan. 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.

  3. Assessments of the Histology of the Bone Harvested at the 3 Month Visit.

    Time frame: 3 months

    Measure quantitative histologic characteristics of new bone between the three groups after 3 months of ridge preservation by quantifying the distribution (in %) of new vital bone at the healed socket site. The quality of the bone created will analyzed using a descriptive analysis.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Oct 21, 2019
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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