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 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
78
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Texas
-
San Antonio, Texas, Estados Unidos, 78236
- Air Force Post Graduate Dental School
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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).
|
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.
|
|
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.
|
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.
|
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain: a numeric pain scale (0-10) was used to document site specific palatal harvest pain.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
24 de mayo de 2024
Finalización primaria (Actual)
18 de marzo de 2025
Finalización del estudio (Actual)
18 de marzo de 2025
Fechas de registro del estudio
Enviado por primera vez
26 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de junio de 2026
Publicado por primera vez (Actual)
10 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FWH2024005H
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
All de-identified participant date sets are to be shared upon request.
Marco de tiempo para compartir IPD
Beginning 3 months and ending 3 years after the publication of results.
Criterios de acceso compartido de IPD
The Air Force Post Graduate Dental School will be in charge of allowing access to IPD upon request.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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