Evaluation of Wear Resistance of CAD/CAM Hybrid Ceramic and Nano-Hybrid Composite Overlays in Endodontically Treated Molars and Their Effect on Natural Antagonist Teeth
Evaluation of Wear Resistance of CAD/CAM Hybrid Ceramic and Nano-Hybrid Composite Overlays in Endodontically Treated Molars and Their Effect on Natural Antagonist Teeth: A 24-Month Randomized Clinical Trial
調査の概要
詳細な説明
The rationale for this 24-month RCT is driven by the need for high-level, evidence-based data to guide clinical material selection for compromised teeth. This trial is designed to directly compare two materials specifically engineered to be stress-absorbing in the oral environment. The primary intervention, the SHOFU Restorative System (Hard blocks), is a Hybrid Ceramic engineered to combine the durability of ceramics with the elasticity of polymers. Its reduced hardness and dentin-like modulus allow for rapid machining and are associated with reduced antagonist abrasion compared to conventional ceramics. The second material, serving as the comparator, is the Coltène Restorative System (BRILLIANT Crios), which is a reinforced nano-hybrid composite characterized by an elastic modulus comparable to dentin, designed for optimal shock absorption and confirmed to be gentle on antagonist teeth.
Focusing the study on endodontically treated molars addresses a highly prevalent clinical scenario where maximizing the longevity of the restoration and the remaining tooth structure is paramount. The use of a full-cusp-coverage overlay design represents the maximum conservation approach for these compromised teeth while ensuring that the selected restorative materials do not exert harmful effects on opposing dentition.
研究の種類
入学 (推定)
段階
- 適用できない
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:
- Age between 22 and 45 years.
- Low to moderate caries risk.
- Normal occlusion.
- Absence of signs or symptoms of temporomandibular joint (TMJ) disorders.
- Satisfactory oral hygiene.
- Medically fit to receive routine restorative dental treatment.
- Permanent molars.
- Asymptomatic endodontically treated teeth.
- Homogeneous root canal fillings extending 1-2 mm from the radiographic apex.
- Compound cavities.
- Favorable occlusion.
- Presence of both an adjacent tooth and a sound opposing tooth in occlusion
Exclusion Criteria:
* Presence of bruxism.
- Poor patient cooperation.
- Inability or unwillingness to attend follow-up appointments.
- Anticipated travel during the study period.
- Poor oral hygiene.
- Chronic or advanced periodontitis.
- Known allergies to any of the materials used in the study.
- Patients who are pregnant or breastfeeding.
- Teeth with <1" mm" of residual wall thickness.
- Deep subgingival cavity margins.
- Severe periodontal problems.
- Radiographic signs of apical pathology.
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
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:SHOFU Hard blocks
CAD/CAM Hybrid Ceramic, Overlay restored using the SHOFU cementation system.
|
CAD/CAM Hybrid Ceramic, Overlay restored using the SHOFU cementation system.
|
|
アクティブコンパレータ:BRILLIANT Crios
Resin-based Composite, Overlay restored using the Coltène cementation system.
|
Resin-based Composite, Overlay restored using the Coltène cementation system.
|
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 |
|---|---|---|
|
Annual wear rate
時間枠:24 months
|
Digital Scanner +Geometrical Subtraction Software
|
24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Functional properties, Biological properties and Esthetic properties
時間枠:24 months
|
FDI Criteria
|
24 months
|
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 (推定)
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
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。