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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 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

78

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Texas
      • San Antonio, Texas, Stati Uniti, 78236
        • Air Force Post Graduate Dental School

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Procedura: Platelet rich fibrin
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.
Altro: Control Group: collagen matrices or oxidized cellulose membrane
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.
Sperimentale: 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.
Procedura: Platelet rich fibrin
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.
Altro: Control Group: collagen matrices or oxidized cellulose membrane
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.
Sperimentale: 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.
Procedura: Platelet rich fibrin
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.
Altro: Control Group: collagen matrices or oxidized cellulose membrane
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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.
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain: a numeric pain scale (0-10) was used to document site specific palatal harvest pain.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

59th Medical Wing

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 maggio 2024

Completamento primario (Effettivo)

18 marzo 2025

Completamento dello studio (Effettivo)

18 marzo 2025

Date di iscrizione allo studio

Primo inviato

26 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 giugno 2026

Primo Inserito (Effettivo)

10 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FWH2024005H

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

All de-identified participant date sets are to be shared upon request.

Periodo di condivisione IPD

Beginning 3 months and ending 3 years after the publication of results.

Criteri di accesso alla condivisione IPD

The Air Force Post Graduate Dental School will be in charge of allowing access to IPD upon request.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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