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

Not Applicable

Active, not recruiting

• Conditions: Ridge Preservation
• Interventions: Procedure: Ridge preservation using L-PRF/FDBA layered technique; Procedure: Ridge preservation using L-PRF/FDBA; Procedure: Ridge preservation using L-PRF

• Registration Number: NCT04133363
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-21
• Study Start: 2020-06-15
• Primary Completion: 2021-10-27
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 31

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ridge preservation using L-PRF/ FDBA Layered	Ridge preservation using L-PRF/FDBA layered technique	Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA layered technique
Ridge preservation using L-PRF/ FDBA	Ridge preservation using L-PRF/FDBA	Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA
Ridge preservation using L-PRF	Ridge preservation using L-PRF	Atraumatic tooth extraction following by socket grafting using L-PRF alone

Primary Outcome Measures

Name	Time	Method
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	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.
Assessments of the Histology of the Bone Harvested at the 3 Month Visit.	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.
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	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States