Clinical Evaluation of 3D-Printed Versus Direct Composite Restorations in Class II Cavities
The aim of this study is to clinically evaluate the performance of 3D-printed composites compared to direct conventional composite restorations in Class II cavities
調査の概要
状態
詳細な説明
Resin-based composites are widely used for posterior restorations because of their esthetics, adhesion, and conservative preparation. However, Class II restorations remain challenging due to polymerization shrinkage, marginal gaps, postoperative sensitivity, and inadequate proximal contacts. Digital additive manufacturing has emerged as a promising approach, offering precise fabrication, reduced material waste, and customizable restorations. Although laboratory studies suggest favorable mechanical properties and marginal adaptation, clinical evidence for 3D-printed intracoronal restorations remains limited. Therefore, this randomized clinical trial will compare the clinical performance of 3D-printed composite inlays with conventional direct composite restorations in Class II cavities over 24 months.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Egypt
-
Tanta、Egypt、エジプト、31511
- aculty of Dentistry, Tanta University, Tanta, Tanta 31527
-
-
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:
- Have at least two Class II carious lesions corresponded to ICDAS scores 4 and 5, representing dentinal caries suitable for operative restorative treatment.
- The absence of ongoing orthodontic treatment or use of prostheses.
- Good general health without relevant disease.
Exclusion Criteria:
- Uncooperative patient.
- Any parafunctional habits such as tooth clenching or grinding.
- Chronic pulmonary diseases and blocked nasal passages.
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:他の
- 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:3D-Printed Composite Inlays
Participants will receive Class II restorations fabricated from a commercially available 3D-printable permanent composite resin using a standardized digital workflow. The restorations will be adhesively bonded to the prepared cavities according to the manufacturer's instructions. |
Class II cavities will be restored with digitally designed and 3D-printed permanent composite inlays. The restorations will be post-cured and adhesively cemented according to the material manufacturer's recommendations |
|
アクティブコンパレータ:Direct Composite Restorations
Participants will receive conventional direct Class II restorations using a commercially available resin-based composite. Restorations will be placed incrementally using a standardized adhesive protocol and light-curing procedure according to the manufacturer's recommendations. Both groups will be clinically evaluated at baseline and during the 18-month follow-up period using standardized clinical criteria. |
Class II cavities will be restored directly using a conventional light-cured resin-based composite placed with a standardized incremental technique and adhesive protocol |
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 |
|---|---|---|
|
Fracture and retention
時間枠:18 months
|
Description: Clinical evaluation of fracture and retentin was conducted in accordance with the World Dental Federation (FDI) criteria by two calibrated examiners at baseline and after 6, 12, and 18 months. Each restoration was evaluated according to the degree of conformity with the established criteria as follows: score 1, excellent; scores 2 and 3, satisfactory; and scores 4 and 5, inadequate. Scores of 1-3 were considered indicative of clinical success, whereas scores of 4 or 5 were considered indicative of failure. |
18 months
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Balestra D, Lowther M, Goracci C, Mandurino M, Cortili S, Paolone G, Louca C, Vichi A. 3D Printed Materials for Permanent Restorations in Indirect Restorative and Prosthetic Dentistry: A Critical Review of the Literature. Materials (Basel). 2024 Mar 18;17(6):1380. doi: 10.3390/ma17061380.
- Duarte S Jr, Phark JH. Advances in Dental Restorations: A Comprehensive Review of Machinable and 3D-Printed Ceramic-Reinforced Composites. J Esthet Restor Dent. 2025 Jan;37(1):257-276. doi: 10.1111/jerd.13371. Epub 2024 Nov 18.
- Tanaka LEB, da Silva Rodrigues C, Grangeiro MTV, Campos TMB, de Melo RM. Characterization of 3D printed composite for final dental restorations. Clin Oral Investig. 2024 Oct 31;28(11):617. doi: 10.1007/s00784-024-06003-8.
- Peskersoy C, Oguzhan A. Evaluation of the Mechanical and Adhesion Characteristics of Indirect Restorations Manufactured with Three-Dimensional Printing. Polymers (Basel). 2024 Feb 23;16(5):613. doi: 10.3390/polym16050613.
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
その他の研究ID番号
- 3D-Printed & Direct Composite
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。