Root Coverage Performance of Restorative Materials in Class V Cavities
Clinical Evaluation of the Root Coverage Performance of Different Restorative Materials in Class V Cavities in Patients With Gingival Recession
調査の概要
状態
詳細な説明
Gingival recession associated with non-carious cervical lesions (NCCLs) is a common clinical condition that may result in dentin hypersensitivity, root caries, and esthetic concerns. When root coverage surgery is indicated, the presence or absence of a cervical restoration and the type of restorative material may influence soft tissue healing and the stability of the surgical outcome. However, evidence regarding the optimal restorative approach before periodontal plastic surgery remains limited.
This prospective randomized controlled clinical trial will compare the clinical performance of different restorative approaches in Class V cervical lesions undergoing root coverage surgery with a subepithelial connective tissue graft. Eligible patients presenting with Cairo RT1 (Miller Class I-II equivalent) gingival recession and Class V cervical defects will be allocated to one of the study groups according to the study protocol. The interventions include restoration with glass ionomer cement, resin composite or no restoration when appropriate.
All participants will receive standardized periodontal treatment before surgery, followed by root coverage surgery using a subepithelial connective tissue graft. Clinical examinations will be performed at baseline and during follow-up to evaluate treatment outcomes.
The primary outcome is the percentage of root coverage achieved after surgery. Secondary outcomes include changes in gingival recession depth, clinical attachment level, keratinized tissue width, probing depth, dentin hypersensitivity, esthetic outcomes, and the clinical stability of the treated sites. The findings will help determine whether the restorative material placed in Class V cervical lesions influences the success of periodontal root coverage procedures.
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：Zeliha B ÇAKIR ERDİL, DDS
- 電話番号：+905059444038
- メール：bskcakirr@gmail.com
研究連絡先のバックアップ
- 名前：Metin Çalışır, Prof.DR
- メール：metincalisir@adiyaman.edu.tr
研究場所
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Merkez
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Adıyaman、Merkez、トルコ（Türkiye）、02030
- 募集
- Faculty of Dentistry, Adıyaman University
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コンタクト：
- Zeliha B ÇAKIR ERDİL
- 電話番号：05059444038
- メール：bskcakirr@gmail.com
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副調査官：
- Zeliha Başak ÇAKIR ERDİL, DDS
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主任研究者：
- METİN ÇALIŞIR, Prof.Dr.
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-
参加基準
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
説明
Inclusion Criteria:
Adults aged 18 years or older. Patients presenting with Cairo RT1 (Miller Class I or II equivalent) gingival recession defects requiring root coverage surgery.
Presence of a non-carious cervical lesion (NCCL), an existing cervical restoration, or a cervical defect requiring restoration.
Cervical lesion depth of ≤1.5 mm. Patients who have completed initial periodontal therapy before enrollment. Good oral hygiene (Plaque Index ≤20% or as determined by the investigator). Indication for root coverage surgery with a subepithelial connective tissue graft.
Teeth suitable for restoration with glass ionomer cement, resin composite, or flowable resin composite, or requiring no restoration according to the study protocol.
Ability and willingness to provide written informed consent and comply with study visits.
Exclusion Criteria:
- Age younger than 18 years. Pregnancy or breastfeeding. Poor oral hygiene. Uncontrolled systemic disease or any medical condition contraindicating periodontal surgery.
Bleeding disorders or current anticoagulation that contraindicates connective tissue graft harvesting.
Known allergy or hypersensitivity to resin composite, flowable resin composite, glass ionomer cement, or any study materials.
Patients who have not completed initial periodontal therapy. Cervical lesions deeper than 1.5 mm. Conditions that, in the investigator's opinion, could interfere with wound healing, periodontal surgery, or study outcomes.
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 |
|---|---|
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アクティブコンパレータ：No Restoration Control Grou
Participants will be randomly assigned to one of three parallel groups: no restoration control, glass ionomer cement restoration, or resin composite restoration before root coverage surgery.
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No restorative material will be placed in the Class V cervical lesion before root coverage surgery.
Participants will undergo root coverage surgery using a coronally advanced flap with a subepithelial connective tissue graft according to the study protocol.
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実験的：Glass Ionomer Cement Group
Participants will receive restoration of the Class V cervical lesion with glass ionomer cement before root coverage surgery using a subepithelial connective tissue graft.
Clinical outcomes, including the percentage of root coverage and soft tissue healing, will be evaluated during follow-up.
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A conventional glass ionomer cement was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft.
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実験的：Resin Composite Group
Participants will receive restoration of the Class V cervical lesion with resin composite before root coverage surgery using a subepithelial connective tissue graft.
Clinical outcomes, including the percentage of root coverage and soft tissue healing, will be evaluated during follow-up.
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A resin composite material was used to restore the Class V cervical lesion before root coverage surgery with a subepithelial connective tissue graft.
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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 |
|---|---|---|
|
Percentage of Root Coverage
時間枠：Baseline to 6 months after surgery
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The percentage of root coverage will be evaluated after root coverage surgery in Class V cervical lesions treated with different restorative approaches, including glass ionomer, resin composite, flowable composite, or no restoration.
The outcome will assess which material or approach provides greater soft tissue coverage over the cervical/root surface.
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Baseline to 6 months after surgery
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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
キーワード
その他の研究ID番号
- HRU-25.18.53
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?
IPD プランの説明
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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