このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities

2026年6月13日 更新者:Sayed Ahmed Sayed Karim、Cairo University

Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities: Two-Year Randomized Clinical Trial

this study aims to compare the clinical performance of hard hybrid ceramics and composite resin indirect restorations fabricated by CAD/CAM technology for the vital teeth with occluso-proximal cavities. the clinical performance assessed include marginal adaptation primarily and in addition to Color match, marginal discoloration, aesthetic anatomic form, recurrent caries and restoration fracture and post-operative hypersensitivity. the clinical performance will be assessed after the restoration cementation, after 6, 12, 18 and 24 months.

調査の概要

状態

まだ募集していません

詳細な説明

A wide variety of materials is now available for the fabrication of indirect restorations used to manage extensive carious lesions, including high-strength ceramics, hybrid ceramics, and resin-composite blocks. Each material offers distinct advantages in strength, wear resistance, aesthetics, and bonding performance, thereby expanding treatment options for severely compromised posterior teeth. However, these differences in mechanical and optical behavior, marginal adaptation, and long-term durability under functional stresses complicate clinical material selection.

Limited data is available comparing the clinical performance of these materials, particularly in large cavities in these regions. More information is needed on how they prevent post-treatment sensitivity, maintain edge quality, and resist discoloration, wear, and fractures.

Though short-term studies indicate excellent survival rates and aesthetic results for CAD/CAM hybrid ceramic inlays (more than 90% survival after two years), and systematic reviews imply that CAD/CAM resin composite inlays match ceramic restorations (success rates ranging from 85.7% to 100% for composites versus 93.3% to 100% for ceramics). There is a lack of direct clinical comparisons between these two material types in vital molars with occluso-proximal cavities. Much of the existing research is constrained to onlay designs or mixed-material groups, creating a significant gap in understanding which CAD/CAM block type delivers superior long-term performance for inlay restorations in vital teeth.

研究の種類

介入

入学 (推定)

50

段階

  • 適用できない

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

  • 子
  • 大人

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Systematically healthy male or female subjects aged 16 to 50 years.
  • Patients with good oral hygiene.
  • Presence of a single vital molar with coronal destruction due to caries, defined as radiographic evidence of caries involving more than 50% of the total dentin thickness with loss of at least one proximal wall.
  • Cavitary preparation involving loss of at least one proximal walls (mesial and/or distal), with intact buccal and lingual walls, and all cavosurface margins located in enamel.
  • Presence of functional opposing teeth in stable occlusion

Exclusion Criteria:

  • Presence of systemic diseases (e.g., uncontrolled diabetes, immune disorders).
  • Current pregnancy or lactation.
  • Documented allergy to resin-based composites or adhesive systems.
  • Evidence of pulpal necrosis or previous endodontic treatment in the target tooth.
  • Presence of cracks or fractures involving the tooth structure.
  • Active localized or generalized periodontal disease.
  • Evidence of parafunctional habits, including bruxism or clenching.
  • High caries risk.

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:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Hybrid ceramic group
indirect restoration (inlay design) using CAD/CAM Fabricated Hard Hybrid Ceramic blocks
after caries removal, inlay cavity preparation and immediate dentin sealing, the cavities were scanned using intraoral scanner and the restoration designed and milled using Hard Hybrid Ceramic Blocks. the intaglio surface was air-abraded with 50 μm Al2O3 for 10-15 seconds. SHOFU HC Primer will be applied to the hybrid-ceramic group.
アクティブコンパレータ:Composite Resin group
indirect restoration (inlay design) using CAD/CAM Fabricated from Composite Resin Blocks
after caries removal, inlay cavity preparation and immediate dentin sealing, the cavities were scanned using intraoral scanner and the restoration designed and milled using Composite Resin Blocks. the intaglio surface was air-abraded with 50 μm Al2O3 for 10-15 seconds.

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
Marginal Adaptation
時間枠:-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation

二次結果の測定

結果測定
メジャーの説明
時間枠
color match
時間枠:-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
marginal discoloration
時間枠:-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
aesthetic anatomic form
時間枠:-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
recurrent caries
時間枠:-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
restoration fracture
時間枠:-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
Post-operative hypersensitivity
時間枠:-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation

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

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

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8月1日

一次修了 (推定)

2028年8月1日

研究の完了 (推定)

2028年11月1日

試験登録日

最初に提出

2026年6月10日

QC基準を満たした最初の提出物

2026年6月10日

最初の投稿 (実際)

2026年6月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月16日

QC基準を満たした最後の更新が送信されました

2026年6月13日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

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?

未定

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

いいえ

米国FDA規制機器製品の研究

いいえ

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。

購読する