Microneedling-Assisted Hyaluronic Acid for Interdental Papilla Deficiency
Microneedling-Assisted Hyaluronic Acid for Interdental Papilla Deficiency: Effects on Gingival Crevicular Fluid Biomarkers and Clinical Outcomes-A Randomized Controlled Clinical Trial
This randomized controlled clinical trial will evaluate whether microneedling combined with cross-linked hyaluronic acid injection provides superior reconstruction of interdental papilla deficiency compared with hyaluronic acid injection alone. Twenty participants with Nordland-Tarnow Class I or II interdental papilla deficiency will be randomly allocated into two parallel groups. The test group will receive microneedling followed by submucosal injection of cross-linked hyaluronic acid, while the control group will receive cross-linked hyaluronic acid injection alone. Three treatment sessions will be performed at 4-week intervals. Participants will be followed for 6 months. The primary outcome will be change in black triangle height. Secondary outcomes will include gingival crevicular fluid levels of MMP-9, TIMP-1 and periostin, plaque index, gingival index, periodontal probing depth, and patient satisfaction.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
参加基準
適格基準
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:
- Young adult patients aged .
- Presence of at least one interdental papilla defect classified as Nordland-Tarnow Class I or II.
- Distance between the contact point and the interproximal bone crest ≤7 mm.
- No open contact between the affected teeth.
- Full-mouth periodontal treatment completed prior to enrollment.
- Willingness to participate and ability to provide written informed consent.
Exclusion Criteria:
- Systemic conditions affecting wound healing, soft tissue turnover, or immune response, including uncontrolled diabetes mellitus, immunosuppression, or coagulation disorders.
- Current use of anticoagulants, systemic corticosteroids, bisphosphonates, or medications known to affect gingival tissue or bone metabolism.
- Known hypersensitivity or allergy to hyaluronic acid or any component of the injectable preparation.
- Pregnancy or breastfeeding.
- Active periodontal disease.
- Nordland-Tarnow Class III papilla loss at the study site.
- Previous soft tissue augmentation procedures, surgical or injectable, at the study site.
- Use of any local or systemic anti-inflammatory medication within 3 months before enrollment.
- Smokers.
- Presence of restorations, crowns, veneers, or orthodontic brackets at or adjacent to the study site.
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：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Microneedling + Hyaluronic Acid (MN+HA)
Participants will receive microneedling of the interdental papilla followed by submucosal injection of cross-linked hyaluronic acid. Three treatment sessions will be performed at 4-week intervals. |
A sterile disposable microneedling device will be applied to the interdental papilla using controlled vertical and oblique strokes until uniform punctate bleeding is observed. Cross-linked hyaluronic acid will be administered by submucosal injection into the interdental papilla. Three treatment sessions will be performed at 4-week intervals. |
|
アクティブコンパレータ：Hyaluronic Acid (HA)
Participants will receive submucosal injection of cross-linked hyaluronic acid without preceding microneedling. Three treatment sessions will be performed at 4-week intervals. |
Cross-linked hyaluronic acid will be administered by submucosal injection into the interdental papilla. Three treatment sessions will be performed at 4-week intervals. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Black Triangle Height
時間枠：Baseline, 1 month, 3 months, and 6 months
|
Black triangle height will be measured in millimeters as the linear distance from the base of the interproximal contact point to the most coronal tip of the interdental papilla using a calibrated UNC-15 periodontal probe. Standardized acrylic stents will be used to ensure reproducible probe angulation and reference point positioning. |
Baseline, 1 month, 3 months, and 6 months
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Gingival Crevicular Fluid Periostin Level
時間枠：Baseline, 1 month, 3 months, and 6 months
|
Periostin concentration in gingival crevicular fluid will be measured using a commercially available human periostin ELISA kit. |
Baseline, 1 month, 3 months, and 6 months
|
|
Gingival Crevicular Fluid MMP-9 Level
時間枠：Baseline, 1 month, 3 months, and 6 months
|
MMP-9 concentration in gingival crevicular fluid will be measured using a commercially available human MMP-9 ELISA kit. |
Baseline, 1 month, 3 months, and 6 months
|
|
Gingival Crevicular Fluid TIMP-1 Level
時間枠：Baseline, 1 month, 3 months, and 6 months
|
TIMP-1 concentration in gingival crevicular fluid will be measured using a commercially available human TIMP-1 ELISA kit. |
Baseline, 1 month, 3 months, and 6 months
|
|
Plaque Index
時間枠：Baseline, 1 month, 3 months, and 6 months
|
Plaque accumulation will be assessed using the Silness and Löe Plaque Index on a score from 0 to 3. |
Baseline, 1 month, 3 months, and 6 months
|
|
Gingival Index
時間枠：Baseline, 1 month, 3 months, and 6 months
|
Gingival inflammation will be assessed using the Löe and Silness Gingival Index on a score from 0 to 3. |
Baseline, 1 month, 3 months, and 6 months
|
|
Periodontal Probing Depth
時間枠：Baseline, 1 month, 3 months, and 6 months
|
Periodontal probing depth will be measured in millimeters from the gingival margin to the base of the sulcus or periodontal pocket using a UNC-15 periodontal probe. |
Baseline, 1 month, 3 months, and 6 months
|
|
Patient Satisfaction
時間枠：6 months
|
Patient satisfaction with esthetic appearance will be assessed using a visual analogue scale at the end of the follow-up period. |
6 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
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