Topical Corticosteroid and Wound Healing After Periodontal Flap Surgery
Effect of Topical Corticosteroid Application on Early Wound Healing After Periodontal Flap Surgery: A Randomized Split-Mouth Clinical Trial
This randomized split-mouth clinical trial aims to evaluate the effect of topical corticosteroid application on postoperative wound healing and pain following periodontal flap surgery in patients with periodontitis. Forty participants requiring bilateral periodontal flap surgery in the maxilla will be included. In each participant, one surgical site will be randomly assigned to receive topical triamcinolone acetonide 0.1% after surgery, while the contralateral site will serve as the control and will receive periodontal flap surgery without topical corticosteroid application. Wound healing, postoperative pain, and periodontal probing depth will be evaluated during the follow-up period.
調査の概要
詳細な説明
Periodontitis is a chronic inflammatory disease that may require periodontal flap surgery when adequate treatment outcomes cannot be achieved with non-surgical periodontal therapy alone. Postoperative pain and early wound healing are important factors affecting patient comfort and recovery following periodontal surgery. Topical corticosteroids have anti-inflammatory properties and are widely used for various inflammatory conditions of the oral mucosa; however, evidence regarding their use following periodontal flap surgery is limited.
This prospective, randomized, controlled, split-mouth clinical trial will evaluate the effect of a single topical application of triamcinolone acetonide 0.1% following periodontal flap surgery. Forty patients with periodontitis who require bilateral periodontal flap surgery in the maxilla will be enrolled.
Each participant will undergo periodontal flap surgery at two contralateral maxillary sites in separate surgical sessions. Using random allocation, one site will receive topical triamcinolone acetonide 0.1% following suturing, whereas the contralateral site will undergo the same surgical procedure without topical corticosteroid application and will serve as the control. Thus, each participant will serve as their own control.
Postoperative wound healing and pain will be evaluated during follow-up, together with changes in periodontal probing depth. The split-mouth design is intended to reduce the influence of interindividual variability when comparing the two treatment conditions.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Meral UZUNKAYA, ASSISTANT PROFESSOR
- 電話番号：+903443003824
- メール：meraluzunkaya@ksu.edu.tr
研究場所
-
-
-
Kahramanmaraş、トルコ（Türkiye）
- 募集
- Kahramanmaras Sutcu Imam University, Faculty of Dentistry
-
コンタクト：
- Meral UZUNKAYA, ASSISTANT PROFESSOR
- 電話番号：+903443003824
- メール：meraluzunkaya@ksu.edu.tr
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Aged 18 years or older Systemically healthy Diagnosed with periodontitis Requiring bilateral periodontal flap surgery in the maxilla Presence of comparable contralateral maxillary surgical sites suitable for a split-mouth design Willing and able to provide written informed consent For female participants, postmenopausal status
Exclusion Criteria:
- Women of childbearing potential Pregnant or lactating women Current smokers Presence of systemic diseases or conditions that may affect periodontal wound healing Use of medications that may affect periodontal tissues or wound healing Inability or unwillingness to comply with the study procedures and scheduled follow-up visits
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：支持療法
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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 |
|---|---|
|
実験的：Topical Triamcinolone
Participants will undergo open flap debridement (OFD) at the randomly assigned test site in the maxilla. Following completion of the surgical procedure and suturing, 0.1% triamcinolone acetonide will be applied topically to the surgical site as a single application. Each participant will also receive the control intervention at the contralateral maxillary site in a separate surgical session. |
A single topical application of 0.1% triamcinolone acetonide will be administered to the randomly assigned experimental surgical site following completion of open flap debridement and suturing.
他の名前：
Open flap debridement (OFD) will be performed at the periodontal surgical site. The surgical procedure will be performed at both the experimental and control sites in separate surgical sessions. |
|
アクティブコンパレータ：Control
Participants will undergo open flap debridement (OFD) at the contralateral maxillary control site without topical corticosteroid application. Each participant will also receive the experimental intervention at the opposite maxillary site in a separate surgical session. |
Open flap debridement (OFD) will be performed at the periodontal surgical site. The surgical procedure will be performed at both the experimental and control sites in separate surgical sessions. |
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 |
|---|---|---|
|
Early Wound Healing Index (EHI)
時間枠：Postoperative days 7, 14, and 45 after each surgical procedure.
|
Postoperative wound healing will be assessed using the Early Wound Healing Index (EHI) at the surgical sites. The index evaluates early healing of the surgical wound based on clinical characteristics of the incision line. |
Postoperative days 7, 14, and 45 after each surgical procedure.
|
|
Postoperative Pain Assessed by Visual Analog Scale (VAS)
時間枠：Postoperative days 7, 14, and 45 after each surgical procedure.
|
Postoperative pain will be assessed using a Visual Analog Scale (VAS). Participants will rate their pain intensity on a 0-10 scale, where 0 represents no pain and 10 represents the worst imaginable pain. VAS scores will be compared between the topical triamcinolone and control surgical sites. |
Postoperative days 7, 14, and 45 after each surgical procedure.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Periodontal Probing Depth (PPD)
時間枠：Baseline and postoperative day 45 after each surgical procedure.
|
Periodontal probing depth (PPD) will be measured in millimeters using a periodontal probe. Changes in PPD will be evaluated by comparing baseline measurements with postoperative measurements at the surgical sites. |
Baseline and postoperative day 45 after each surgical procedure.
|
協力者と研究者
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
- PFK-2026-01
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?
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
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。