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.

NCT07637838 | Completed DMC

• 1 other identifier: FWH2024005H
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

quality of life; platelet-rich fibrin; pain; palate; wound healing

Outcome Measures

Primary Outcomes (2)

• 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.

  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). The additive OHIP-14 score served as the primary outcome variable. The quality of life survey was completed pre-surgically, 24 hours, 72 hours, 1 week, and 2 weeks.

  Pre-surgical survey to 2 weeks following surgical intervention.

• Sleep Quality: sleep efficiency index obtained from wearable device.

  A sleep monitoring device was issued to patients following informed consent (SleepImage® Ring 2019, SleepImage, Denver, CO). 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.

  1 week pre-surgery to 2-weeks following surgical intervention.

Secondary Outcomes (3)

• Pain: a numeric pain scale (0-10) was used to document site specific palatal harvest pain.

  From pre-surgery survey, final survey was 2 weeks post surgical intervention.

• Analgesic Consumption: a survey tool was used to document patients medication use post-surgery.

  From pre-surgery survey to two weeks post surgical intervention.

• Physiologic Healing at Palatal Donor Site: 5-point healing scale

  Healing was assessed at 1-week and 2-weeks post surgical intervention.

Study Arms (3)

Quality of Life

EXPERIMENTAL

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).

Procedure: Platelet rich fibrin; Other: Control Group: collagen matrices or oxidized cellulose membrane

Sleep Quality

EXPERIMENTAL

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.

Procedure: Platelet rich fibrin; Other: Control Group: collagen matrices or oxidized cellulose membrane

Healing

EXPERIMENTAL

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.

Procedure: Platelet rich fibrin; Other: Control Group: collagen matrices or oxidized cellulose membrane

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.

Healing; Quality of Life; Sleep Quality

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.

Healing; Quality of Life; Sleep Quality

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 or \< 99
• required a mucogingival surgery
• had not taken an antibiotic for one month
• planned for a non-emergent periodontal procedure

You may not qualify if:

• pregnant or within 6 months post-partum
• female subjects who are nursing
• subjects who are decisionally challenged
• patients who have undergone antibiotic therapy in the past month
• ASA IV or higher status
• patients who have undergone chronic therapy with medications that could affect periodontal status or healing
• incompatible mobile phone devices.

Sponsors & Collaborators

• 59th Medical Wing: lead

Study Sites (1)

Air Force Post Graduate Dental School

San Antonio, Texas, 78236, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontics Resident, Air Force Officer

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 10, 2026
• Study Start: May 24, 2024
• Primary Completion: March 18, 2025
• Study Completion: March 18, 2025
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 3 years after the publication of results.
• Access Criteria: The Air Force Post Graduate Dental School will be in charge of allowing access to IPD upon request.

Locations

US (1)