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.
2026年6月4日 更新者：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.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
78
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Texas
-
San Antonio、Texas、アメリカ、78236
- Air Force Post Graduate Dental School
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：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.
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain: a numeric pain scale (0-10) was used to document site specific palatal harvest pain.
時間枠：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.
時間枠：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
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年5月24日
一次修了 (実際)
2025年3月18日
研究の完了 (実際)
2025年3月18日
試験登録日
最初に提出
2026年5月26日
QC基準を満たした最初の提出物
2026年6月4日
最初の投稿 (実際)
2026年6月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月10日
QC基準を満たした最後の更新が送信されました
2026年6月4日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- FWH2024005H
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
All de-identified participant date sets are to be shared upon request.
IPD 共有時間枠
Beginning 3 months and ending 3 years after the publication of results.
IPD 共有アクセス基準
The Air Force Post Graduate Dental School will be in charge of allowing access to IPD upon request.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。