Active Oxygen Gel Versus Hyaluronic Acid Gel for Palatal Wound Healing After Free Gingival Graft (OXYHA-FGG)
Effectiveness of Active Oxygen Gel Versus Hyaluronic Acid Gel on Palatal Wound Healing After Free Gingival Graft: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial aims to evaluate and compare the effectiveness of different palatal dressing materials on wound healing following free gingival graft harvesting.
Thirty systemically healthy patients with mucogingival defects requiring free gingival graft procedures will be enrolled from the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University. Patients will be randomly allocated into three equal groups (10 patients each). Group A (control) will receive a gelatin sponge with flowable composite on the donor site. Group B will receive hyaluronic acid gel covered with a gelatin sponge and flowable composite. Group C will receive active oxygen gel covered with a gelatin sponge and flowable composite.
Postoperative outcomes will be assessed in terms of pain (visual analog scale), analgesic consumption, clinical wound healing (Landry healing index), complete wound re-epithelialization (hydrogen peroxide test), dimensional changes of the wound, and occurrence of complications. Evaluations will be performed at baseline and during follow-up visits up to four weeks postoperatively.
The study aims to determine which dressing material provides better postoperative comfort and enhances palatal wound healing after free gingival graft procedures.
調査の概要
状態
詳細な説明
This study is a randomized controlled clinical trial designed to evaluate the effect of different palatal dressing materials on wound healing following free gingival graft harvesting.
The study will be conducted at the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University, after approval of the Research Ethics Committee and Faculty Council. Thirty systemically healthy patients diagnosed with mucogingival defects requiring free gingival graft procedures will be recruited according to predefined inclusion and exclusion criteria. All participants will sign an informed consent form prior to enrollment.
Patients will be randomly allocated into three equal groups (n = 10 per group) using a computer-generated randomization method. Group A (control group) will receive a gelatin sponge covered with flowable composite on the palatal donor site. Group B will receive hyaluronic acid gel covered with a gelatin sponge and flowable composite. Group C will receive active oxygen gel (Blue®m) covered with a gelatin sponge and flowable composite.
Free gingival grafts will be harvested using the classical Sullivan and Atkins technique. The grafts will be adapted and sutured at the recipient site using resorbable sutures. At the donor site, hemostasis will be achieved using pressure with adrenaline-soaked gauze, followed by application of the assigned dressing protocol for each group.
Postoperative care will include analgesics (Ibuprofen 600 mg as needed), chlorhexidine mouth rinse (0.12%) twice daily for two weeks, and standard postoperative instructions. Patients will be recalled after 1 week for evaluation and removal/reapplication of the dressing when indicated, and again at 2 and 4 weeks for follow-up assessments.
Outcome measures include postoperative pain assessed using a visual analog scale (VAS), total analgesic consumption, wound healing evaluated by Landry healing index, complete wound re-epithelialization assessed using hydrogen peroxide test, two-dimensional wound measurements, and recording of any postoperative complications.
Statistical analysis will be performed using appropriate tests including ANOVA or Kruskal-Wallis test for comparison among groups, and repeated measures analysis for longitudinal data. A p-value ≤ 0.05 will be considered statistically significant.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Ismailia Governorate
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Ismailia、Ismailia Governorate、エジプト
- 募集
- Faculty of Dentistry, Suez Canal University
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コンタクト：
- Shimaa Nasser
- 電話番号：+201117286714
- メール：pgs.230036@dent.suez.edu.eg
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コンタクト：
- Shimaa Morsy
- 電話番号：+20 12 2552703
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Systemically healthy patients Age between 18 and 60 years Patients with mucogingival defects requiring free gingival graft Adequate palatal thickness (>3 mm) Cooperative and motivated patients Good oral hygiene compliance
Exclusion Criteria:
Systemic diseases that contraindicate surgical procedures Smokers Pregnant or lactating females Immunocompromised patients Patients undergoing chemotherapy or radiotherapy Poor oral hygiene or non-compliant patients Palatal infection
研究計画
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Control group
Participants will receive a gelatin sponge covered with flowable composite applied to the palatal donor site after free gingival graft harvesting as the control dressing for wound management.
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Gelatin sponge covered with flowable composite applied to the palatal donor site after free gingival graft harvesting as the standard control dressing for wound management
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実験的：Hyaluronic acid group
Participants will receive hyaluronic acid gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting.
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Hyaluronic acid gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting to enhance wound healing.
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実験的：Active oxygen group (Blue®m)
Participants will receive active oxygen gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting.
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Active oxygen gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting to enhance wound healing.
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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 |
|---|---|---|
|
Wound healing (Landry Healing Index)
時間枠：1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
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Assessment of palatal wound healing using the Landry Healing Index, which uses a score ranging from 1 to 5, with higher scores indicating better wound healing.
The assessment includes tissue color, response to palpation, bleeding, granulation tissue, incision margin, and suppuration.
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1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Complete epithelialization (Hydrogen peroxide test)
時間枠：1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
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Assessment of complete wound epithelialization using hydrogen peroxide bubbling test.
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1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
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Two-dimensional wound area reduction
時間枠：Baseline, 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
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Measurement of the palatal wound surface area (length × width) to assess two-dimensional reduction in wound size over time after free gingival graft harvesting.
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Baseline, 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
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Postoperative pain (VAS score)
時間枠：Daily for the first postoperative week (Day 1 to Day 7)
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Evaluation of postoperative pain using the Visual Analog Scale (VAS), ranging from 0 to 10, with higher scores indicating greater pain, after free gingival graft harvesting in the three study groups.
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Daily for the first postoperative week (Day 1 to Day 7)
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- 919/2024
- suez canal university (その他の識別子：suez canal university)
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
米国FDA規制機器製品の研究
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