Characterizing the Effects of Platelet-Rich Fibrin (PRF) as a Palatal Wound Dressing on Quality of Life and Sleep Following Mucogingival Surgery. Study Was Conducted at the Air Force Post Graduate Dental School. All HIPPA Consents and Research Informed Consents Are Located at JBSA-Lackland.

Part of paid clinical trials in San Antonio, Texas.

Sponsor
59th Medical Wing
Study ID
NCT07637838
Status
Completed

Conditions

  • Analgesic Consumption
  • Pain
  • Palatal Donor Site Wound Healing
  • Platelet Rich Fibrin
  • Sleep Quality

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Platelet rich fibrin — PROCEDURE
    The test group had approximately 40 ml of whole venous blood collected from their antecubital fossa (R/L) prior to surgical start for the fabrication of PRF. Tubes were placed immediately into a US Food and Drug Administration (FDA)-approved horizontal centrifuge (Horizon 6 Drucker Diagnostics; Port Matilda, PA), and spun at 2300 rpm (700 g) for 16 min. After the centrifugation was complete, the PRF matrices were compressed into membranes. At the completion of surgery, PRF membranes (1-3) were used as a wound dressing at the harvest site. A palatal stent was used to secure the PRF via compression only, and no sutures were utilized for fixation at the harvest sites. Patients were instructed not to remove the palatal stent for 48 hours.
  • Control Group: collagen matrices or oxidized cellulose membrane — OTHER
    On the day of surgery, subjects randomized into the control group had a commercially available product of the surgeons choice (collagen matrices or oxidized cellulose membrane) placed at the palatal donor site. The matrix was compressed with a palatal stent and subjects were instructed to not remove the stent for 48 hours.

Study Details

The goal of this clinical trial (2-arm) is to determine if the application of platelet rich fibrin (PRF) to palatal donor sites influence patients quality of life, sleep efficiency, and healing following mucogingival surgery. All patients were enrolled in the Air Force Post Graduate Dental School periodontics program and each patient required mucogingival surgery. The main question\[s\] it aims to answer \[is/are\]: * Does the application of PRF to palatal donor sites influence patient's quality of life following mucogingival surgery. \[outcome measure 1\] * Does the application of PRF to palatal donor sites influence patient's sleep quality following mucogingival surgery. \[outcome measure 2\] * Does the application of PRF to palatal donor sites influence palatal healing following mucogingival surgery. \[outcome measure 3\] Researchers will compare the application of PRF (test) as a palatal dressing to a commercially available product (control; oxidized cellulose membrane or collagen dressing) to determine the difference of effects. Participants will be randomly assigned to either receiving PRF or a commercially available product on the day of surgery. A survey response will be conducted at five time points (pre-operative, 24-hours, 72 hours, 1 week, 2 week) to obtain a quality of life metric. Sleep data was collected via a wearable device one week pre-surgical intervention and two weeks postoperatively. Finally, a clinical healing index was performed at 1 and 2 weeks post-operatively to obtain a healing score.

Key Dates

Start date
May 24, 2024
Status verified
Jun 2026
Primary completion
Mar 18, 2025
Completion
Mar 18, 2025

Study Design

Enrollment
78 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Quality of Life
    The Qualtrics survey tool sent out automated emails at 24 hours, 72 hours, 1-week and 2-week time points from the time of pre-surgery survey completion. Surveys included: (1) OHIP-14 questionnaire, which includes 14 questions related to seven different patient domains; (2) What is your pain at the palatal harvest site on a scale of 0-10? (NRS-11); and (3) Did you take any mediation today to relieve pain or swelling? (yes/no).
  • Experimental: Sleep Quality
    After informed consent is obtained at the pre-op appointment, subjects undergoing mucogingival surgery will be given a sleep monitoring device (SleepImage® Ring 2019, SleepImage, Denver, CO) and will complete a baseline QoL (Qualtrics XM®, 2002, Qualtrics, Seattle WA). The sleep monitoring app will be downloaded on subjects' phones and each subject will be briefed on the function of the application. Subjects will be instructed to wear the device nightly throughout the study. The subject will be instructed to complete the same QoL questionnaire at 24 hours, and 72 hours, as well as at the one-week and two-week post-operative appointments.
  • Experimental: Healing
    At 1- and 2- weeks, patients returned for post-operative appointments. At the follow-up appointment the surgeons were asked to document the presence of suppuration or bleeding at the palatal wound site. A standardized photograph was then taken with the following parameters (F-stop: 29, ISO: 200, Shutter Speed: 125). Three calibrated, blinded examiners then assessed the palatal wound based on the Landry et al palatal healing index.

Primary Outcome Measure

Quality of Life: OHIP-14 summative scores utilized as a quality of life metric at five different time points. These scores were compared between the test and control group. [ Time Frame: Pre-surgical survey to 2 weeks following surgical intervention. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Air Force Post Graduate Dental SchoolSan AntonioTexas78236-

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