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.
4 juni 2026 bijgewerkt door: David Seiler, 59th Medical Wing
Characterizing the Effects of Leukocyte-Platelet-Rich Fibrin on Sleep and Perceived Quality of Life on Mucogingival Periodontal Surgery Healing. Arm 1: Influence of Platelet-rich Fibrin on Quality of Life Following Mucogingival Surgery: A Randomized Controlled Trial.
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
78
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Texas
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San Antonio, Texas, Verenigde Staten, 78236
- Air Force Post Graduate Dental School
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- age > 18 or < 99
- required a mucogingival surgery
- had not taken an antibiotic for one month
- planned for a non-emergent periodontal procedure
Exclusion Criteria:
- 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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).
|
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.
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.
|
|
Experimenteel: 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.
|
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.
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.
|
|
Experimenteel: 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.
|
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.
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
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.
Tijdsspanne: Pre-surgical survey to 2 weeks following surgical intervention.
|
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.
Tijdsspanne: 1 week pre-surgery to 2-weeks following surgical intervention.
|
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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain: a numeric pain scale (0-10) was used to document site specific palatal harvest pain.
Tijdsspanne: From pre-surgery survey, final survey was 2 weeks post surgical intervention.
|
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.
Survey question: What is your pain at the palatal harvest site on a scale of 0-10?
(NRS-11)
|
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.
Tijdsspanne: From pre-surgery survey to two weeks post surgical intervention.
|
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.
Survey question: Did you take any mediation today to relieve pain or swelling?
(yes/no).
|
From pre-surgery survey to two weeks post surgical intervention.
|
|
Physiologic Healing at Palatal Donor Site: 5-point healing scale
Tijdsspanne: Healing was assessed at 1-week and 2-weeks post surgical intervention.
|
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.
|
Healing was assessed at 1-week and 2-weeks post surgical intervention.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
24 mei 2024
Primaire voltooiing (Werkelijk)
18 maart 2025
Studie voltooiing (Werkelijk)
18 maart 2025
Studieregistratiedata
Eerst ingediend
26 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
4 juni 2026
Eerst geplaatst (Werkelijk)
10 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
4 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- FWH2024005H
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
All de-identified participant date sets are to be shared upon request.
IPD-tijdsbestek voor delen
Beginning 3 months and ending 3 years after the publication of results.
IPD-toegangscriteria voor delen
The Air Force Post Graduate Dental School will be in charge of allowing access to IPD upon request.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- ANALYTIC_CODE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .