Palatal Donor Site Wound HealingNCT07637838
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.
A study testing Platelet rich fibrin in people with Palatal Donor Site Wound Healing and Platelet Rich Fibrin, run by 59th Medical Wing at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Palatal Donor Site Wound Healing, Platelet Rich Fibrin, Sleep Quality
- What is being tested?
- Platelet rich fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2024to 18 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 or < 99
- required a mucogingival surgery
- had not taken an antibiotic for one month
- planned for a non-emergent periodontal procedure
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Air Force Post Graduate Dental School
San Antonio, Texas, 78236
About this study
Official title: 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.
- Conditions
- Palatal Donor Site Wound Healing, Platelet Rich Fibrin, Sleep Quality, Pain, Analgesic Consumption
- Being tested
- Platelet rich fibrin, Control Group: collagen matrices or oxidized cellulose membrane
- Keywords
- quality of life, platelet-rich fibrin, pain, palate, wound healing
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrinProcedure or surgery
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.
Control Group: collagen matrices or oxidized cellulose membraneOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Test Group: Horizontally Centrifuged PRF membranes used as palatal dressing | Experimental | 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 placed at the harvest site. A palatal stent was used to secure the wound dressings via compression only, and no sutures were utilized for fixation at the harvest sites. Receives: Procedure: Platelet rich fibrin |
| Control Group: Collagen wound dressing or oxidized cellulose membrane | Active comparator | The control group had a commercially available wound dressing placed at the harvest site. A palatal stent was used to secure the wound dressing via compression only, and no sutures were utilized for fixation at the harvest sites. Receives: Other: Control Group: collagen matrices or oxidized cellulose membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life: Oral Health Impact Profile -14 (OHIP-14). Summative Scores Were Utilized as a Quality of Life Metric at Five Different Time Points. These Scores Were Compared Between the Test and Control Group.
OHIP-14 Questionnaire: includes 7 patient domains (2 questions for each domain).
- Functional Limitation
- Physical pain
- Psychological discomfort
- Physical disability
- Psychological disability
- Social disability
- Handicap
Patients are asked to answer questions on the 5-point Likert scale below. The additive total of the 14 questions is the total OHIP-14 score. Lower scores correlate to higher Quality of Life (QoL). A mixed model regression was run with a PRF wound dressing as the independent variable. Therefore, all scores were combined and time was factored in the mixed modeled regression. This is why only one statistical analysis score is noted.
Likert Scale answer choices: Very Often(4), Fairly Often(3), Occasionally(2), Hardly Ever (1), Never(0).
Range: 0-54. High QoL (OHIP Score: < 19), Moderate QoL (OHIP-14 Score: 19-37), Low QoL (OHIP-14 Score 38-56).
OHIP-14 was completed pre-surgically, 24 hours, 72 hours, 1 week, and 2 weeks.
Measured: Pre-surgical survey to 2 weeks following surgical intervention.
Sleep Quality: Sleep Quality Index (SQI) Was Obtained From Wearable Device Which Serves as a Summary Index of the Cardiopulmonary Coupling Biomarkers of Sleep Quality, Sleep Stability, Fragmentation, and Periodicity.
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.
SQI (sleep quality index) scale is 1-100. Higher numbers are consistent with a higher quality sleep.
Average baseline (pre-surgery) SQI was recorded. 24 hour, 72 hour, average sleep quality in week 1, and average sleep quality in week 2.
A mixed model regression was run with a PRF wound dressing as the independent variable. Therefore, all scores were combined and time was factored in the mixed modeled regression. This is why only one statistical analysis score is noted for sleep analysis.
Measured: 1 week pre-surgery to 2-weeks following surgical intervention.
Secondary outcomes (3)
Pain: a Numeric Pain Scale (0-10) Was Used to Document Site Specific Palatal Harvest Pain.
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 asking a question regarding pain at the palatal harvest site.
Survey question: What is your pain at the palatal harvest site on a scale of 0-10? (NRS-11).
0 (minimum) indicates no pain. 10 (maximum) is extreme pain.
A mixed model regression was run with a PRF wound dressing as the independent variable. Therefore, all scores were combined and time was factored in the mixed modeled regression. This is why only one statistical analysis score is noted.
Measured: From pre-surgery survey, final survey was 2 weeks post surgical intervention.
Analgesic Consumption: a (Yes/No) Survey Question Was Asked Regarding Analgesic Consumption. If the Patient Answered "Yes" to Using Medications to Relieve Pain, They Were Added to the Number of Participants Who Used Medication at That Time Point.
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).
This was measured by number of participants who took medication to relieve pain and swelling. If a participant answered "Yes" to the survey question at the specific time point, they were counted as having taking medications to relieve pain or swelling. If they answered "No" they were note included. Amount of analgesic use was not documented. Simply a dichotomous "Yes" or "No".
A mixed model regression was run with a PRF wound dressing as the independent variable. Therefore, all scores were combined and time was factored in the mixed modeled regression. This is why only one statistical analysis score is noted.
Measured: From pre-surgery survey to two weeks post surgical intervention.
Physiologic Healing at Palatal Donor Site: 5-point Healing Scale Landry et al Scale
At the follow-up appointments 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). Two calibrated, blinded examiners then assessed the palatal wound based on the Landry et al palatal healing index. Each examiner provided a score (1-5). Lower scores = poorer healing. Higher scores = advanced healing. If the scores were not in concordance, a third calibrated blind examiner assessed the palatal wound based on the Landry et al palatal healing index. This served as the "tie-breaker" score. For example, if examiner #1 scored a (1), and examiner #2 scored a (2), the palate was examined by the third examiner. If examiner #3 scored a (2) then the patient received a score of (2). If the third examiner scored a different number then both examiners, then the highest and lowest score were removed and the middle score was recorded.
Measured: Healing was assessed at 1-week and 2-weeks post surgical intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start24 May 2024
- Primary completion18 Mar 2025
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Palatal Donor Site Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- 59th Medical Wing
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, David Seiler, 59th Medical Wing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637838
- Sponsor's protocol ID
- FWH2024005H
- Status last verified
- Oct 2026
- First submitted
- 26 May 2026
- Last updated
- 29 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified participant date sets are to be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07637838
- Acronym / sponsor ID
- FWH2024005H
- Conditions
- Palatal Donor Site Wound Healing, Platelet Rich Fibrin, Sleep Quality, Pain, Analgesic Consumption
- Keywords
- quality of life, platelet-rich fibrin, pain, palate, wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- 59th Medical WingUS federal agency
- Study start
- 24 May 2024 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 10 Jun 2026 (actual)
- Results
- Posted 29 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group: Horizontally Centrifuged PRF membranes used as palatal dressing | Experimental | Procedure: Platelet rich fibrinThe 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 placed at the harvest site. A palatal stent was used to secure the wound dressings via compression only, and no sutures were utilized for fixation at the harvest sites. |
| Control Group: Collagen wound dressing or oxidized cellulose membrane | Active comparator | Other: Control Group: collagen matrices or oxidized cellulose membraneThe control group had a commercially available wound dressing placed at the harvest site. A palatal stent was used to secure the wound dressing via compression only, and no sutures were utilized for fixation at the harvest sites. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18 or < 99
- required a mucogingival surgery
- had not taken an antibiotic for one month
- planned for a non-emergent periodontal procedure
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich fibrinThe 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. | Procedure or surgery | Test Group: Horizontally Centrifuged PRF membranes used as palatal dressing |
| Control Group: collagen matrices or oxidized cellulose membraneOn 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. | Other | Control Group: Collagen wound dressing or oxidized cellulose membrane |
Primary outcome
Quality of Life: Oral Health Impact Profile -14 (OHIP-14). Summative Scores Were Utilized as a Quality of Life Metric at Five Different Time Points. These Scores Were Compared Between the Test and Control Group.
Time frame: Pre-surgical survey to 2 weeks following surgical intervention.
OHIP-14 Questionnaire: includes 7 patient domains (2 questions for each domain). 1. Functional Limitation 2. Physical pain 3. Psychological discomfort 4. Physical disability 5. Psychological disability 6. Social disability 7. Handicap Patients are asked to answer questions on the 5-point Likert scale below. The additive total of the 14 questions is the total OHIP-14 score. Lower scores correlate to higher Quality of Life (QoL). A mixed model regression was run with a PRF wound dressing as the independent variable. Therefore, all scores were combined and time was factored in the mixed modeled regression. This is why only one statistical analysis score is noted. Likert Scale answer choices: Very Often(4), Fairly Often(3), Occasionally(2), Hardly Ever (1), Never(0). Range: 0-54. High QoL (OHIP Score: < 19), Moderate QoL (OHIP-14 Score: 19-37), Low QoL (OHIP-14 Score 38-56). OHIP-14 was completed pre-surgically, 24 hours, 72 hours, 1 week, and 2 weeks.
Sleep Quality: Sleep Quality Index (SQI) Was Obtained From Wearable Device Which Serves as a Summary Index of the Cardiopulmonary Coupling Biomarkers of Sleep Quality, Sleep Stability, Fragmentation, and Periodicity.
Time frame: 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. SQI (sleep quality index) scale is 1-100. Higher numbers are consistent with a higher quality sleep. Average baseline (pre-surgery) SQI was recorded. 24 hour, 72 hour, average sleep quality in week 1, and average sleep quality in week 2. A mixed model regression was run with a PRF wound dressing as the independent variable. Therefore, all scores were combined and time was factored in the mixed modeled regression. This is why only one statistical analysis score is noted for sleep analysis.
3 secondary outcomes
Pain: a Numeric Pain Scale (0-10) Was Used to Document Site Specific Palatal Harvest Pain.
Time frame: From pre-surgery survey, final survey was 2 weeks post surgical intervention.
Analgesic Consumption: a (Yes/No) Survey Question Was Asked Regarding Analgesic Consumption. If the Patient Answered "Yes" to Using Medications to Relieve Pain, They Were Added to the Number of Participants Who Used Medication at That Time Point.
Time frame: From pre-surgery survey to two weeks post surgical intervention.
Physiologic Healing at Palatal Donor Site: 5-point Healing Scale Landry et al Scale
Time frame: Healing was assessed at 1-week and 2-weeks post surgical intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All de-identified participant date sets are to be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich fibrin in people with Palatal Donor Site Wound Healing and Platelet Rich Fibrin, run by 59th Medical Wing at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life: Oral Health Impact Profile -14 (OHIP-14). Summative Scores Were Utilized as a Quality of Life Metric at Five Different Time Points. These Scores Were Compared Between the Test and Control Group. (time frame: Pre-surgical survey to 2 weeks following surgical intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.