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

NCT ID: NCT04133363

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2023-01-31

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.

Conditions

Ridge Preservation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ridge preservation using L-PRF/ FDBA Layered

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

Group Type: EXPERIMENTAL

Ridge preservation using L-PRF/FDBA layered technique

Intervention Type: PROCEDURE

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

Ridge preservation using L-PRF/ FDBA

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

Group Type: EXPERIMENTAL

Ridge preservation using L-PRF/FDBA

Intervention Type: PROCEDURE

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

Ridge preservation using L-PRF

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

Group Type: EXPERIMENTAL

Ridge preservation using L-PRF

Intervention Type: PROCEDURE

Atraumatic tooth extraction following by socket grafting using L-PRF

Interventions

Ridge preservation using L-PRF/FDBA layered technique

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

Intervention Type: PROCEDURE

Ridge preservation using L-PRF/FDBA

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

Intervention Type: PROCEDURE

Ridge preservation using L-PRF

Atraumatic tooth extraction following by socket grafting using L-PRF

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Nicolaas C. Geurs, DDS, MS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB-300004112

Identifier Type: -

Identifier Source: org_study_id