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

The University of Alabama at Birmingham

Status: Completed

Conditions: Ridge Preservation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04133363

IRB-300004112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Ridge preservation using L-PRF/ FDBA Layered

Experimental group

Description:

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

Treatment:

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

Ridge preservation using L-PRF/ FDBA

Experimental group

Description:

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

Treatment:

Procedure: Ridge preservation using L-PRF/FDBA

Ridge preservation using L-PRF

Experimental group

Description:

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

Treatment:

Procedure: Ridge preservation using L-PRF