The Effect of Vertically Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft Versus Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft on Gingival Recession.
2026年8月30日 更新者：Mai Magdy Abu El Eneen、Cairo University
The Effect of Vertically Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft Versus Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft on Gingival Recession: A Randomized Clinical Trial
The aim of this randomized clinical trial will be to assess the change in recession depth after using a vertically coronally advanced flap with sub-epithelial connective tissue graft compared to a coronally advanced flap with sub-epithelial connective tissue graft after 6 months.
調査の概要
状態
まだ募集していません
詳細な説明
To test new approaches for root coverage for the treatment of RT1 and RT2 gingival recession.
研究の種類
介入
入学 (推定)
26
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。
研究連絡先
- 名前：Mai Magdy Abu El Eneen, PHD candidate
- 電話番号：0201123864563
- メール：mai.abueleneen@dentistry.cu.edu.eg
研究場所
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Cairo、エジプト、11562
- Faculty of dentistry cairo ubiversity
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コンタクト：
- Mai Abu El Eneen, PHD candidate
- 電話番号：+201123864563
- メール：mai.abueleneen@dentistry.cu.edu.eg
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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 years.
- Systemically healthy.
- Non-smokers.
- Full-mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.
- Presence of identifiable CEJ.
- Absence of non-carious cervical lesions.
- Mature permanent tooth in the aesthetic zone.
- At least one recession defect type RT1 and/ or RT2 in the upper or lower jaw.
- Thin gingival phenotype (GT < 0.8 mm) via probe transparency method.
- A minimum of (2 mm KTW).
Exclusion Criteria:
- Any systemic disease.
- Pregnancy or lactation.
- Cairo RT3 recession defects.
- Teeth with active orthodontic treatment.
- Previous periodontal surgery in the area.
- Use of any drugs that might lead to gingival enlargement.
- Smoking.
- Caries, restoration, mobility, unstable endodontic condition, and malocclusion in teeth undergoing treatment.
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Coronally Advanced flap combined with sub-epithelial connective tissue graft
The combination of a SCTG with CAF was regarded as the gold standard for root coverage procedures
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The combination of a SCTG with CAF was regarded as the gold standard for root coverage procedures
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実験的：Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft
Vertically coronally advanced flap combined with a subepithelial connective tissue graft for the treatment of gingival recession defects.
The procedure involves preparation and coronal advancement of a vertically designed flap to cover the exposed root surface, followed by placement of a subepithelial connective tissue graft beneath the flap to enhance soft-tissue thickness and root coverage.
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Vertically coronally advanced flap combined with a subepithelial connective tissue graft for the treatment of gingival recession defects.
The procedure involves preparation and coronal advancement of a vertically designed flap to cover the exposed root surface, followed by placement of a subepithelial connective tissue graft beneath the flap to enhance soft-tissue thickness and root coverage.
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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 |
|---|---|---|
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Change in recession depth (mm)
時間枠：at Baseline and 6 months
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Change in recession depth in millimeters will be measured using a UNC-15 periodontal probe as the distance from the cementoenamel junction towards the most apical extension of the gingival margin
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at Baseline and 6 months
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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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Gingival Recession Width (mm)
時間枠：at baseline and 6 months
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Gingival recession width will be measured in millimeters using a UNC-15 periodontal probe as the distance from the base of the mesial to the distal papillae along the cementoenamel junction.
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at baseline and 6 months
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Keratinized Tissue Width (mm)
時間枠：at Baseline and 6 months
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Keratinized tissue width will be measured in millimeters using a UNC-15 periodontal probe from the gingival margin at the deepest recession point till the mucogingival junction (MGJ), which will be identified using the roll technique
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at Baseline and 6 months
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Keratinized Tissue Height (mm)
時間枠：at Baseline and 6 months
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Keratinized tissue height will be measured in millimeters using a UNC-15 periodontal probe from the gingival margin to the mucogingival junction.
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at Baseline and 6 months
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Probing Depth (mm)
時間枠：at Baseline and 6 months
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Probing depth will be measured in millimeters using a UNC-15 periodontal probe as the distance from the base of the gingival crevice to the marginal gingiva.
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at Baseline and 6 months
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Gingival Thickness (mm)
時間枠：at Baseline and 6 months
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Gingival thickness will be measured in millimetres using endodontic spreader no. 15 with a silicon disk stopper will be performed apical to the gingival margin by 2 mm at the middle of the long axis of the tooth mesio-distally using a UNC-15 periodontal probe.The depth of penetration will be measured using a ruler with precision up to the nearest 0.5 mm.
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at Baseline and 6 months
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Recession Reduction (mm)
時間枠：at Baseline and 6 months
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Recession reduction will be calculated by comparing the initial gingival recession depth and gingival depth after treatment using a UNC-15 periodontal probe.
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at Baseline and 6 months
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Clinical Attachment Level (mm)
時間枠：at Baseline and 6 months
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Clinical attachment level will be identified using a UNC-15 periodontal probe as the distance from the cementoenamel junction to the bottom of the gingival sulcus.
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at Baseline and 6 months
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Complete Root Coverage (%)
時間枠：at 6 months
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Complete root coverage will be assessed by calculating the percentage of cases exhibiting a gingival margin that was either level with or positioned coronally to the cementoenamel junction in each group.
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at 6 months
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Bleeding on Probing (+/-)
時間枠：at Baseline and 6 months
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Bleeding on probing (BOP) will be measured using an UNC-15 periodontal probe, gently probing the gingival crevice, beginning inter-proximally from the mesial aspect and moving towards the distal.
A positive finding for BOP will be recorded when bleeding occurred within 10s.
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at Baseline and 6 months
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Plaque Index (scores 0, 1, 2, 3)
時間枠：at Baseline and 6 months
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Plaque index will be determined by drying the teeth in each quadrant with a gentle air blast, where the visibility of dental plaque and supragingival calculus will be noted. Each four tooth surfaces (buccal, lingual, mesial and distal) will be scored from 0 to 3, then scores of the four areas will be added and divided by four to give the average plaque index for each tooth. Scores: 0 : No plaque 1 : A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye. 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. |
at Baseline and 6 months
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Post-Operative Pain (VAS) Visual Analogue Scale Questionnaire
時間枠：Surgical day and days 1, 3, 7, and 14 after surgery
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Post-operative pain will be indirectly evaluated on the basis of the mean consumption (in mg) of analgesics (ibuprofen).
A questionnaire will be given to each patient; it will be divided into two parts to be completed in different time periods: the first part, regarding the post-operative discomfort and bleeding will be completed 1 week after the surgery based on a visual analogue scale of 100 mm.Postoperative pain will be assessed using a 100-mm Visual Analogue Scale, ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), with higher scores indicating greater pain.
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Surgical day and days 1, 3, 7, and 14 after surgery
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Patient Esthetic Satisfaction (RES) Root Coverage Esthetic Score
時間枠：at 6 months
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Patient aesthetic satisfaction will be assessed using the root coverage esthetic score (RES) at the 6 months follow up visit.
The following five parameters will be evaluated: gingival margin level (0 = failure of root coverage; 3 = partial root coverage; 6 = complete root coverage), marginal tissue contour (0 = irregular; 1 = proper), soft tissue texture (0 = presence of scar/keloid; 1 = absence of scar/ keloid), mucogingival junction (MGJ) (0 = MGJ not aligned; 1 = MGJ aligned), and gingival color (0 = color differs from adjacent teeth; 1 = normal color and integration).
A total RES score will be calculated by adding these 5 components
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at 6 months
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Mean Percentage of Root Coverage (mRC) %
時間枠：(subtraction of gingival RD at baseline from gingival RD at 6 months divided by gingival RD at baseline) multiplied by 100
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Mean percentage of root coverage (mRC) will be calculated after 6 months as the percentage reduction in gingival recession depth from baseline to 6 months post-treatment, using the following formula: mRC (%) = [(RD₀ - RD6) / RD₀] × 100, where RD₀ represents the gingival recession depth at baseline and RD6 represents the gingival recession depth at 6 months post-treatment.
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(subtraction of gingival RD at baseline from gingival RD at 6 months divided by gingival RD at baseline) multiplied by 100
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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
捜査官
- 主任研究者：Mai Magdy Abu El Eneen, PHD candidate、Cairo University
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 (推定)
2026年9月1日
一次修了 (推定)
2027年3月1日
研究の完了 (推定)
2027年11月1日
試験登録日
最初に提出
2026年8月11日
QC基準を満たした最初の提出物
2026年8月30日
最初の投稿 (実際)
2026年9月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月3日
QC基準を満たした最後の更新が送信されました
2026年8月30日
最終確認日
2026年8月1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。