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

Ridge Preservation Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04133363
• Other study ID #: IRB-300004112
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: December 2023

Study information

• Verified date: August 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: December 2023
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ridge Preservation

Intervention

Procedure:
• 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
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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 using an intraoral scan and direct clinical assessment. 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
Primary	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 clinical and radiographic alveolar ridge dimensions (in mm) 3 months after ridge preservation between the three groups using a CBCT scan and implant planning software. 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. In addition the two CBCT's will be overplayed and using specialized software we will measure the change in bone width at the various aspects of the site, lingual mesial buccal and distal.	From baseline to 3 months
Primary	Quantitative and qualitative assessments of the histology of the bone harvested at the 3 month visit.	Compare quantitative and qualitative histologic characteristics of new bone between the three groups after 3 months of ridge preservation by quantifying the distribution (in %) of new vital bone, connective tissue, residual graft particles, and artifact at the healed socket site. Using specialized software the distribution of new bone, redial graft and other tissues will be quantitated. The quality of the bone created will analyzed using a descriptive analysis.	From baseline to 3 months