Prosthetic Complications in Full-arch Screw-retained Implant Restorations Using Monolithic Zirconia Versus Titanium Frameworks: A Randomized Clinical Trial
調査の概要
状態
条件
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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Cairo、エジプト、11553
- 募集
- Faculty of Dentistry - Cairo University
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コンタクト:
- Faculty of Dentistry - Cairo University
- 電話番号:0020223642705
- メール:dentmail@dentistry.cu.edu.eg
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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:
- Aged 18 years or older.
- Able to understand the study procedures and provide written informed consent.
- In good general health, classified as American Society of Anesthesiologists (ASA) Physical Status Class I or II.
- Completely edentulous in the arch to be treated (maxilla and/or mandible).
- A candidate for a full-arch, screw-retained implant-supported prosthesis, requiring 4 to 6 implants in the treatment arch.
- Sufficient bone volume at planned implant sites to place implants of at least 3.5mm in diameter and 8mm in length.
- Adequate crown height space (15-22 mm) for a fixed prosthesis.
- A zone of keratinized mucosa at the crest of the ridge measuring at least 2 mm in width.
- Opposing arch is fixed full-arch implant-supported prosthesis.
- Demonstrates acceptable oral hygiene and the motivation to maintain it.
Exclusion Criteria:
Medical contraindications:
- Uncontrolled diabetes (HbA1c > 7.0%).
- History of radiotherapy in the head and neck region.
- History of intravenous bisphosphonate therapy.
- Immunosuppressed or immunocompromised status.
- Any other uncontrolled systemic disease that constitutes a contraindication for oral surgery.
Behavioral Factors:
- Heavy smoking, defined as consumption of more than 10 cigarettes per day.
- Presence of parafunctional habits (e.g., bruxism, clenching) as diagnosed by clinical examination.
Local Oral Factors:
- Active, untreated periodontal disease in any remaining dentition.
- Presence of acute oral infection or pathology at the intended surgical site.
- Crown height space less than 15 mm or more than 22 mm.
- Insufficient keratinized mucosa (< 2 mm width) that cannot be corrected with a simple surgical procedure prior to implant placement.
General:
- Pregnancy or lactation.
- Participation in another interventional clinical trial.
- Perceived inability to comply with the study protocol and follow-up schedule.
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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実験的:Monolithic zirconia framework
The prosthesis is a one-piece, full-arch framework milled from a single, monolithic zirconia blank.
It includes the infrastructure, prosthetic teeth, and gingival contours.
The prosthesis is screw-retained directly to multi-unit abutments.
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Intervention: Screw-Retained Monolithic Zirconia Prosthesis
他の名前:
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アクティブコンパレータ:CNC-milled titanium framework and zirconia superstructure
The prosthesis consists of two parts: A CNC-milled titanium framework, and a CNC-milled zirconia superstructure that is cemented onto the framework. The titanium framework is screw-retained directly to multi-unit abutments. The zirconia superstructure is permanently cemented to the framework with resin cement. |
The prosthesis consists of two parts: A CNC-milled titanium framework, and a CNC-milled zirconia superstructure that is cemented onto the framework.
The titanium framework is screw-retained directly to multi-unit abutments.
The zirconia superstructure is permanently cemented to the framework with resin cement.
他の名前:
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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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Prosthetic complications
時間枠:1 year
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The primary outcome of this study is the incidence of prosthetic complications over 12-month follow-up period.
A prosthetic complication is defined as any mechanical or technical issue affecting the prosthesis that requires clinical intervention.
This will be assessed through a standardized clinical examination conducted by a calibrated examiner.
The outcome for each participant will be recorded as a binary variable (Yes/No).
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1 year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Oral Health-Related Quality of Life (OHRQoL)
時間枠:1 year
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The secondary outcome of this study is the change in Oral Health-Related Quality of Life (OHRQoL) over the 12-month follow-up period.
This will be measured using the validated Arabic version of the 5-item Oral Health Impact Profile (OHIP5-Ar) questionnaire (Alhajj et al., 2019).
The questionnaire consists of 5 questions, each rated on a Likert scale (e.g., 0 = Never, 1 = Hardly ever, 2 = Occasionally, 3 = Fairly often, 4 = Very often).
The total score ranges from 0 to 20, with a higher score indicating a greater negative impact on OHRQoL.
The change from baseline to 3, 6 and 12 months will be analyzed.
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1 year
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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
その他の研究ID番号
- 09062026
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。
Monolithic Zirconia Prosthesisの臨床試験
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Second Sight Medical ProductsNational Institute of Neurological Disorders and Stroke (NINDS)積極的、募集していない