Analgesic Consumption, Pain, Palatal Donor Site Wound Healing, Platelet Rich Fibrin, Sleep Quality
Conditions
Keywords
quality of life, platelet-rich fibrin, pain, palate, wound healing
Brief 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.
Interventions
PROCEDUREPlatelet 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.
OTHERControl 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.
Sponsors
59th Medical Wing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Sleep Quality: sleep efficiency index obtained from wearable device. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain: a numeric pain scale (0-10) was used to document site specific palatal harvest pain. | 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) |
| Analgesic Consumption: a survey tool was used to document patients medication use post-surgery. | 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). |
| Physiologic Healing at Palatal Donor Site: 5-point healing scale | 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. |
Countries
United States
Outcome results
None listed