Application of L-PRF in Periodontal Surgery

NCT06296498 | Completed

• 1 other identifier: 20230505HU
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontal Diseases

Keywords

Open flap debridement; Periodontal surgery; Periodontal wound healing

Outcome Measures

Primary Outcomes (2)

• Probing depth

  Depth of gingival pocket

  3 months and 6 months

• 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

Study Arms (2)

Group OFD + L-PRF

ACTIVE COMPARATOR

Open flap debridement (OFD) with L-PRF is used during periodontal surgical procedure that is used to improve periodontal health by providing access to the tooth roots and alveolar bone.

Procedure: Leukocyte Platelet-rich fibrin

Group OFD

OTHER

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.

Other: Standard of care OFD

Interventions

Leukocyte Platelet-rich fibrin PROCEDURE

Leukocyte-PRF (L-PRF) contains neutrophils and macrophages that facilitate bacteria and necrotic tissue elimination via phagocytosis

Also known as: L-PRF

Group OFD + L-PRF

Standard of care OFD OTHER

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.

Also known as: Open Flap Debridement

Group OFD

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Charles Powell, DDS, MS

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the intervention which they are randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed study is a split-mouth design, randomized, prospective clinical trial in which we will use either OFD alone or OFD + L-PRF for periodontal surgery. Both procedures are standard of care

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: August 19, 2023
• Primary Completion: December 16, 2025
• Study Completion: December 16, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study completion in a peer review journal

Locations

US (1)