エリスリトール空気研磨と手用器具による歯根表面調整が、修正トンネル法および上皮下結合組織移植を用いた歯肉退縮被覆に及ぼす影響。
エリスリトールエアポリッシングと手用器具による歯根面コンディショニングの影響:改良トンネル法と上皮下結合組織移植を用いた歯肉退縮被覆に関する無作為化臨床試験
This study aims to evaluate whether the method of root surface preparation influences surgical outcomes. It will assess whether manual root instrumentation can be replaced by a less invasive erythritol air-polishing technique.
調査の概要
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:Magdalena Latkowska - Wiśniewska
- 電話番号:+48691470290
- メール:magda.latko@gmail.com
研究連絡先のバックアップ
- 名前:Bartłomiej Górski
- メール:gorskibartlomiej04@gmail.com
研究場所
-
-
Mazowsze
-
Warsaw、Mazowsze、ポーランド、00-246
- 募集
- Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
-
-
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:
- Multiple RT1 and/or RT2 gingival recessions, symmetrical and bilateral, with a minimum height of ≥ 1 mm
- Full-mouth plaque score (FMPS) < 15% (assessed on four surfaces per tooth)
- Full-mouth bleeding on probing (FMBOP) < 15% (assessed on four surfaces per tooth)
- Detectable cemento-enamel junction (CEJ)
- Age ≥ 18 years
Exclusion Criteria:
- RT3 gingival recessions
- Gingival recessions affecting second and third molars
- Systemic or infectious diseases that may impair wound healing, including active malignancy, diabetes mellitus with HbA1c > 7.0%, history of head and neck radiotherapy, true xerostomia, and HIV/AIDS
- Cervical caries, non-carious cervical lesions, or Class V restorations interfering with the CEJ
- Active periodontitis
- Use of medications affecting periodontal tissues or wound healing, including systemic corticosteroids, immunosuppressants, isotretinoin, bisphosphonates, and monoclonal antibodies with immunosuppressive, antiresorptive, or antiangiogenic effects
- Smoking
- Pregnancy or breastfeeding
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:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Erythritol Air-Polishing
Sites with gingival recessions treated with root surface preparation using erythritol air-polishing prior to modified tunnel technique with subepithelial connective tissue graft. |
Root surface preparation performed using erythritol powder air-polishing (EMS AIRFLOW PLUS) prior to root coverage surgery with a modified tunnel technique and subepithelial connective tissue graft. |
|
アクティブコンパレータ:Manual Root Instrumentation
Sites with gingival recessions treated with root surface preparation using manual Gracey curettes prior to modified tunnel technique with subepithelial connective tissue graft. |
Mechanical root surface preparation performed using manual Gracey curettes before root coverage surgery with a modified tunnel technique and subepithelial connective tissue graft. |
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 |
|---|---|---|
|
Mean Root Coverage (MRC, %)
時間枠:6 months and 12 months post-surgery
|
Mean root coverage (MRC), expressed as a percentage (%), assessed at 6 and 12 months post-surgery. MRC is calculated as (GR₀ - GR₆) / GR₀ × 100% and (GR₀ - GR₁₂) / GR₀ × 100%, respectively. Gingival recession (GR), measured in millimeters (mm) as the distance from the cemento-enamel junction (CEJ) to the gingival margin at the mid-buccal aspect of the tooth, is used solely as an input parameter for the calculation of MRC. |
6 months and 12 months post-surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Gingival recession height (GRH, mm)
時間枠:baseline, 6 months, and 12 months post-surgery
|
Distance from the cemento-enamel junction (CEJ) to the gingival margin measured at the mid-buccal aspect of the tooth. |
baseline, 6 months, and 12 months post-surgery
|
|
Gingival recession width (RW, mm)
時間枠:baseline, 6 months, and 12 months post-surgery
|
Horizontal distance measured at the level of the cemento-enamel junction (CEJ) between the mesial and distal margins of the gingival recession. |
baseline, 6 months, and 12 months post-surgery
|
|
Clinical Attachment Level (CAL, mm)
時間枠:Baseline; 6 and 12 months post-surgery
|
Distance from the cemento-enamel junction (CEJ) to the bottom of the gingival sulcus. |
Baseline; 6 and 12 months post-surgery
|
|
Probing Pocket Depth (PPD, mm)
時間枠:baseline, 6 months, and 12 months post-surgery
|
Distance from the gingival margin to the bottom of the gingival sulcus. |
baseline, 6 months, and 12 months post-surgery
|
|
Gingival Thickness (GT, mm)
時間枠:baseline, 6 months, and 12 months post-surgery
|
Thickness of the gingiva measured 3 mm apical to the gingival margin at the mid-buccal aspect of the tooth. |
baseline, 6 months, and 12 months post-surgery
|
|
Keratinized tissue width (KTW, mm)
時間枠:baseline, 6 months, and 12 months post-surgery
|
Distance from the gingival margin to the mucogingival junction |
baseline, 6 months, and 12 months post-surgery
|
|
Complete Root Coverage (CRC, %)
時間枠:6 months and 12 months post-surgery
|
% CRC = (number of teeth with CRC = 1 after treatment / total number of teeth with gingival recession at baseline) × 100. CRC = 1: postoperative GR ≤ 0 mm, indicating complete root coverage. CRC = 0: postoperative GR > 0 mm, indicating partial or no root coverage. |
6 months and 12 months post-surgery
|
|
Gingival Recession Reduction (GR red, mm)
時間枠:6 months and 12 months post-surgery
|
Reduction in recession height at 6 months: GR₀ - GR₆ Reduction in recession height at 12 months: GR₀ - GR₁₂ |
6 months and 12 months post-surgery
|
|
Clinical Attachment Level Gain (CAL Gain, mm)
時間枠:6 months and 12 months post-surgery
|
Clinical attachment level gain at 6 months = CAL₀ - CAL₆ Clinical attachment level gain at 12 months = CAL₀ - CAL₁₂ |
6 months and 12 months post-surgery
|
|
Keratinized Tissue Width Gain (KTW Gain, mm)
時間枠:6 months and 12 months post-surgery
|
Increase in keratinized tissue width at 6 months: KTW₆ - KTW₀ Increase in keratinized tissue width at 12 months: KTW₁₂ - KTW₀ |
6 months and 12 months post-surgery
|
|
Tooth Sensitivity (SEN, Schiff score)
時間枠:Assessed on the day of surgery before administration of anesthesia, and subsequently at 6 and 12 months after surgery.
|
Clinician-assessed tooth sensitivity evaluated using the Schiff Cold Air Sensitivity Scale. Air will be delivered using a standard air syringe of the dental unit, positioned approximately 1 cm from the tooth surface for 5 seconds, at a working temperature of 23 °C (±4 °C), and directed at the exposed buccal surface of the tooth with gingival recession. Patient response to the air stimulus will be assessed by the clinician using the Schiff Cold Air Sensitivity Scale as follows: 0 = No response to the air stimulus
|
Assessed on the day of surgery before administration of anesthesia, and subsequently at 6 and 12 months after surgery.
|
|
Root Esthetic Score (RES, score)
時間枠:6 and 12 months after surgery
|
Root Esthetic Score (RES), expressed as a composite score ranging from 0 to 10 points. The RES is a clinician-assessed composite esthetic outcome comprising the following five components:
The total RES score is calculated as the sum of all component scores, with higher scores indicating a better esthetic outcome. |
6 and 12 months after surgery
|
|
Discomfort during the procedure (VAS, 0-10)
時間枠:Immediately after completion of the procedure
|
Patient-reported discomfort during the procedure assessed using the Visual Analogue Scale (VAS; 0 = no discomfort, 10 = extreme discomfort). |
Immediately after completion of the procedure
|
|
Pain intensity (VAS scale, 0-10)
時間枠:1, 2, 4, 7, 14 days after procedure
|
Patient-reported pain intensity assessed using the Visual Analogue Scale (VAS; 0 = no pain, 10 = maximum pain). |
1, 2, 4, 7, 14 days after procedure
|
|
Postoperative swelling (VAS scale, 0-10)
時間枠:1, 2, 4, 7, 14 days after procedure
|
Patient-reported swelling assessed using the Visual Analogue Scale (VAS; 0 = none, 10 = maximum). |
1, 2, 4, 7, 14 days after procedure
|
|
Tooth sensitivity (VAS, 0-10)
時間枠:1, 2, 4, 7, and 14 days post-procedure
|
Patient-reported tooth sensitivity assessed using the Visual Analogue Scale (VAS; 0 = none, 10 = maximum). |
1, 2, 4, 7, and 14 days post-procedure
|
|
Gingival color (VAS, 0-10)
時間枠:6 and 12 months post-surgery
|
Patient-reported gingival color assessed using the Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent). |
6 and 12 months post-surgery
|
|
Gingival shape (VAS 0-10)
時間枠:6 and 12 months post-surgery
|
Patient-reported gingival shape assessed using a single Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent) |
6 and 12 months post-surgery
|
|
Tooth appearance (VAS, 0-10)
時間枠:6 and 12 months post-surgery
|
Patient-reported tooth appearance assessed using the Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent). |
6 and 12 months post-surgery
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Procedure-related stress (VAS, 0-10)
時間枠:Baseline (day of surgery, pre-anesthesia)
|
Patient-reported procedure-related stress assessed using the Visual Analogue Scale (VAS; 0 = no stress, 10 = extreme stress). |
Baseline (day of surgery, pre-anesthesia)
|
|
Treatment satisfaction (VAS, 0-10)
時間枠:12 months after surgery
|
Patient-reported treatment satisfaction assessed using the Visual Analogue Scale (VAS; 0 = not satisfied at all, 10 = completely satisfied). |
12 months after surgery
|
|
Willingness to choose the treatment again (yes/no)
時間枠:12 months after surgery
|
Patient-reported willingness to choose the same treatment again assessed using a dichotomous (yes/no) question. |
12 months after surgery
|
|
Willingness to recommend the treatment (yes/no)
時間枠:12 months after surgery
|
Patient-reported willingness to recommend the treatment to others assessed using a dichotomous (yes/no) question. |
12 months after surgery
|
協力者と研究者
捜査官
- スタディチェア:Bartłomiej Górski、Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
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
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。