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

NCT04133363 | Completed Results

• 1 other identifier: IRB-300004112
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ridge Preservation

Keywords

L-PRF; Bone Allograft; Ridge Preservation; Socket grafting; Bone regeneration

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  From baseline to 3 months

• 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

  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.

  From baseline to 3 months

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

  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.

  3 months

Study Arms (3)

Ridge preservation using L-PRF/ FDBA Layered

EXPERIMENTAL

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

Procedure: Ridge preservation using L-PRF/FDBA layered technique

Ridge preservation using L-PRF/ FDBA

EXPERIMENTAL

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

Procedure: Ridge preservation using L-PRF/FDBA

Ridge preservation using L-PRF

EXPERIMENTAL

Atraumatic tooth extraction following by socket grafting using L-PRF alone

Procedure: Ridge preservation using L-PRF

Interventions

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 Layered

Ridge preservation using L-PRF/FDBA PROCEDURE

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

Ridge preservation using L-PRF/ FDBA

Ridge preservation using L-PRF PROCEDURE

Atraumatic tooth extraction following by socket grafting using L-PRF

Ridge preservation using L-PRF

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0007, United States

Location

Results Point of Contact

• Title: Nicolaas C. Geurs, DDS, MS, Interim Dean, Principal Investigator
• Organization: University of Alabama at Birmingham

ngeurs@uab.edu

205-9344506

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 21, 2019
• Study Start: June 15, 2020
• Primary Completion: October 27, 2021
• Study Completion: January 31, 2023
• Last Updated: September 26, 2024
• Results First Posted: September 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)