Clinical Evaluation of 3D-Printed Versus Semi-Direct Composite Resin Restorations
調査の概要
状態
詳細な説明
Dental restorations are commonly used to restore teeth affected by caries or structural defects. Advances in digital dentistry have introduced three-dimensional (3D) printing technologies that enable the fabrication of indirect composite resin restorations with improved precision, efficiency, and reproducibility. Semi-direct composite resin restorations represent another conservative restorative approach that combines the advantages of direct and indirect techniques while reducing polymerization shrinkage and improving anatomical form.
Although both techniques are increasingly used in clinical practice, evidence regarding their long-term clinical performance remains limited. Therefore, this randomized controlled clinical trial aims to compare the clinical performance of 3D-printed composite resin restorations and semi-direct composite resin restorations in posterior teeth requiring Class II inlay or onlay restorations.
Sixty patients aged 25 to 40 years who require two Class II inlay or onlay restorations will be enrolled by invitation from patients attending the Faculty of Dentistry, Tanta University. Participants will be randomly allocated into two groups according to the restorative material and fabrication technique used. Group I will receive 3D-printed composite resin restorations, while Group II will receive semi-direct composite resin restorations.
All cavity preparations and restorative procedures will be performed according to standardized clinical protocols and manufacturers' instructions. Clinical evaluations will be conducted at baseline, 6 months, 9 months, and 12 months after restoration placement using the modified FDI World Dental Federation criteria.
The primary objective is to evaluate the overall clinical performance and survival of the restorations over a 12-month follow-up period. Secondary outcomes include assessment of retention, marginal integrity, surface roughness, anatomical form, postoperative sensitivity, and the occurrence of secondary caries.
The findings of this study will contribute to the evidence regarding the effectiveness and clinical reliability of 3D-printed composite resin restorations compared with semi-direct composite resin restorations and may support clinical decision-making in restorative dentistry.
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
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-
Tanta
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Tanta、Tanta、エジプト、31527
- Restorative Department, Faculty of Dentistry, Tanta University
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients aged 25-40 years.
- Patients requiring two Class II inlay or onlay restorations.
- Teeth with carious lesions or defective restorations requiring indirect restorative treatment.
- Teeth with sufficient structure to receive an inlay/onlay restoration.
Exclusion Criteria:
- Patients with systemic diseases or medical conditions that may affect oral health or healing.
- Pregnant or lactating patients.
- Patients with poor oral hygiene or uncontrolled periodontal disease.
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 |
|---|---|
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実験的：3D-Printed Composite Resin Restorations
Participants will receive Class II inlay or onlay restorations fabricated using 3D-printed composite resin.
Restorations will be placed following standardized cavity preparation and manufacturer instructions.
Clinical performance will be evaluated at baseline, 6, 9, and 12 months using modified FDI criteria
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Fabrication and placement of Class II inlay or onlay restorations using 3D-printed composite resin material.
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実験的：Semi-Direct Composite Resin Restorations
Participants will receive Class II inlay or onlay restorations fabricated using the semi-direct composite resin technique.
Restorations will be placed following standardized cavity preparation and manufacturer instructions.
Clinical performance will be evaluated at baseline, 6, 9, and 12 months using modified FDI criteria
|
Fabrication and placement of Class II inlay or onlay restorations using the semi-direct composite resin technique
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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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Fracture of restorations
時間枠：12 months
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Clinical evaluation of restoration fracture or bulk failure after placement of 3D-printed composite resin and semi-direct composite resin restorations.
at baseline, 6 months, 9 months, and 12 months after restoration placement.
using a modified FDI criteria score.
All restorations will be evaluated and categorized based on their clinical performance according to the assigned criteria: score 1 indicates a clinically excellent restoration, scores 2 and 3 represent clinically acceptable restorations, while scores 4 and 5 are considered clinically unacceptable.
Clinical success will be defined as restorations receiving scores of 1, 2, or 3, whereas scores of 4 or 5 will be considered clinical failures.
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12 months
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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
- Nguyen-Thi TL, Tran TM, Tran-Thi HP, Nguyen-Ho PM, Do TT, Dang MH. Effect of preparation design on the fracture behavior of 3D-printed restorations in an in-vitro tooth wear model. BMC Oral Health. 2026 Mar 12;26(1):704. doi: 10.1186/s12903-026-08031-0.
- Tribst JPM, Veerman A, Pereira GKR, Kleverlaan CJ, Dal Piva AMO. Comparative Strength Study of Indirect Permanent Restorations: 3D-Printed, Milled, and Conventional Dental Composites. Clin Pract. 2024 Sep 20;14(5):1940-1952. doi: 10.3390/clinpract14050154.
- Kaffaf MB, Sesen P, Tokac SO. Comparison of the intaglio surface accuracy of occlusal veneers fabricated using two different techniques to restore severe occlusal tooth wear: An in vitro study. J Prosthet Dent. 2026 Jun;135(6):e97-e105. doi: 10.1016/j.prosdent.2025.12.027. Epub 2026 Jan 6.
- Peskersoy C, Acar G. In Vitro Evaluation of the Mechanical Properties of Posterior Adhesive Restorations Fabricated Using Three Different Techniques. Polymers (Basel). 2025 May 14;17(10):1340. doi: 10.3390/polym17101340.
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 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
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