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 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
78
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Texas
-
San Antonio, Texas, Forente stater, 78236
- Air Force Post Graduate Dental School
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
Tidsramme: 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.
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain: a numeric pain scale (0-10) was used to document site specific palatal harvest pain.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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.
|
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
24. mai 2024
Primær fullføring (Faktiske)
18. mars 2025
Studiet fullført (Faktiske)
18. mars 2025
Datoer for studieregistrering
Først innsendt
26. mai 2026
Først innsendt som oppfylte QC-kriteriene
4. juni 2026
Først lagt ut (Faktiske)
10. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FWH2024005H
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
All de-identified participant date sets are to be shared upon request.
IPD-delingstidsramme
Beginning 3 months and ending 3 years after the publication of results.
Tilgangskriterier for IPD-deling
The Air Force Post Graduate Dental School will be in charge of allowing access to IPD upon request.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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