N/A N=30 Randomized Single-blind Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT04133363 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: 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 — 0.88; 0.78; 0.83 mm

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ridge preservation using L-PRF/FDBA layered technique (Procedure); Ridge preservation using L-PRF/FDBA (Procedure); Ridge preservation using L-PRF (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Oct 2021

Outcome Measures

Outcome	Result	p-value
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	0.88; 0.78; 0.83	—
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	1.03; 0.48; 0.9	—
PRIMARY Assessments of the Histology of the Bone Harvested at the 3 Month Visit.	52.15; 58.26; 38.59	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04133363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.