Application of L-PRF in Periodontal Surgery

Periodontal Diseases Clinical Trial

Official title:

The Effect of Application of L-PRF in Periodontal Surgery on Clinical Parameters and Patient Related Outcome Measures: A Randomized, Controlled, Clinical Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296498
• Other study ID #: 20230505HU
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2023
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Charles Powell, DDS, MS
• Phone: 210-567-3593
• Email: powellc2[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will compare the clinical outcomes of the two procedures, open flap debridement (OFD) compared to open flap debridement with leukocyte and platelet-rich fibrin (L-PFR) as well as differences in patient postoperative pain perception.

Description:

Randomization to one of two standard of care procedures: 1. Test group: After gingival flap reflection and debridement of bone and root surfaces L-PRF will be applied to the alveolar bone, tooth roots, and gingival flap prior to suturing. 2. Control group (Standard of care): Gingival flap reflection and debridement of bone and root surfaces, followed by suturing of the gingival flaps. The study is a split-mouth design, randomized, prospective clinical trial. The protocol will randomize gingival quadrants in subjects to one of two standard of care procedures OFD or OFD + L-PRF. Patients needing periodontal surgery to correct periodontal disease will be enrolled. There will be two subject groups in this study. Each subject will be randomized to one of the treatments for the first quadrant and the contralateral quadrant will receive the other treatment. No risk is expected from being assigned to either group as both procedures are standard of care, with possible benefit of enhanced wound healing and bone regeneration in the test group. Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Patients between age 18 and 89
• Patients needing open flap debridement procedures for periodontal disease in one or more teeth in the same arch bilaterally (split mouth)
• Patients must be nonsmokers, former smokers, or current smokers who smoke <10 cigarettes per day, by self-report
• Female patients to include non- pregnant women of child-bearing potential.

Exclusion Criteria:

• Patients who disclose that they will not be able to cooperate with the follow-up schedule.
• Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
• Pregnant women or women intending to become pregnant during the study period
• Smokers who smoke > 10 cigarettes per day

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Procedure:
• Leukocyte Platelet-rich fibrin
Leukocyte-PRF (L-PRF) contains neutrophils and macrophages that facilitate bacteria and necrotic tissue elimination via phagocytosis

Other:
• Standard of care OFD
Open flap debridement (OFD) is one periodontal surgical procedure that is used to improve periodontal health by providing access to the tooth roots and alveolar bone.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing depth	Depth of gingival pocket	3 months and 6 months
Primary	Postoperative Pain (PROM)	Change in Patient reported outcome measures measured by a 10 point scale with 0 being no pain and 10 is the worst pain ever experienced.	12 to 168 hours post surgery