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Completed
NCT07637838
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.
Conditions: Palatal Donor Site Wound Healing, Platelet Rich Fibrin, Sleep Quality, Pain, Analgesic Consumption
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: NA
Enrollment: 78
Sponsor: 59th Medical Wing
Location: Air Force Post Graduate Dental School San Antonio Texas
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07637838). StuddyBuddy aggregates publicly available trial information.