Post Market Clinical Follow up (PMCF) Medical Device Registry of Z-Systems Zirconia Dental Products: Z-Systems Registry
Post Market Clinical Follow up (PMCF) Medical Device Registry of Z-Systems Zirconia Dental Products: Z-Systems Registry Z-Systems Sub-Registry Plan: Z5-BL Dental Implants Z-Systems Sub-Registry Plan: Z5-TL Dental Implants
Commercially pure (CP) titanium is the gold standard to produce dental implants because it has a huge volume of scientific publications over a period of more than 50 years, it is cheap and simple to produce (i.e., making dental implants economically "affordable") and comes in numerous specific designs of screws for various indications. That is why more than 95% of the implant market is dominated by titanium.
However, there is an innovation trend to manufacture implants from more inert and biocompatible materials. Ceramic implants represent a valuable alternative for expanding the patient base of clinicians, especially in cases with challenging aesthetic demand. Furthermore, there has been a significant increase in the number of patients requesting metal-free dentistry or bio-holistic implant treatments.
In the past, ceramics were often branded as "inferior" quality due to its reputation as being brittle but the growing volume of scientific publications specifically on zirconia are demonstrating that it is comparable in fracture-strength with titanium implants. There is a clear market niche for zirconia implants, especially in cases of:
- Aesthetic reconstructions in the anterior region, especially in patients with a thin gingival biotype
- Gingival recessions where a white colored implant is a great advantage
- For patients with a titanium intolerance/sensitivity
- For patients who prefer a bio-holistic/metal-free dental approach.
Today, clinicians are asking for long-term clinical results of zirconia as a dental implant material. Therefore, Z-Systems AG is conducting this zirconia dental implant registry. A registry design was chosen because it will capture long-term benefits/risks from clinical routine without patient selection.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Nutcha Bürki
- 電話番号：+41623886969
- メール：clinical@zsystems.com
研究場所
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Olten、スイス、4600
- 募集
- Praxis am Klosterplatz
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コンタクト：
- Luca Egloff, Dr. med. dent.
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Sankt Gallen、スイス、9000
- 募集
- HeilPraxis - ZahnMedizin
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コンタクト：
- Gábor Róza, Dr. med. dent.
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Grenchen
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Solothurn、Grenchen、スイス、2540
- 募集
- Praxis dentblanche AG
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コンタクト：
- Dominik Aerni, Dr. med. dent.
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Berlin、ドイツ、14193
- 募集
- MVZ Stiller GmbH
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コンタクト：
- Michael Stiller, Prof. Dr. Dr.
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Köpenick、ドイツ、12559
- 募集
- Gemeinschaftspraxis Börner, Hagen
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コンタクト：
- Lars Börner, Dr. med. dent.
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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
サンプリング方法
調査対象母集団
The patient population are anyone needing to have their missing teeth replaced.
説明
Inclusion Criteria:
- Adult patient (≥ 18 years) was or will be implanted with up to 5 implants of the Z-Systems Z5-BL or Z5-TLproduct group
- Patient has signed Informed Consent.
Exclusion Criteria:
- None
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
- 観測モデル：COHORT
- 時間の展望：OTHER
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Z5-BL 歯科インプラント
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This is an observational study, collecting data on the use of Z5-BL Dental Implants. |
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Z5-TL 歯科インプラント
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This is an observational study, collecting data on the use of Z5-BL Dental Implants. |
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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Absence of persistent subjective complaints
時間枠：12 months post-loading final prostheis
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Absence of persistent subjective complaints such as pain, foreign body sensation and/or dysesthesia |
12 months post-loading final prostheis
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Absence of peri-implant infection
時間枠：12 months post-loading final prostheis
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Absence of peri-implant infection with suppuration |
12 months post-loading final prostheis
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Absence of mobility
時間枠：12 months post-loading final prostheis
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Absence of mobility of dental implant |
12 months post-loading final prostheis
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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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Frequency of occurrence of device related Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs).
時間枠：At implant surgery, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery)
|
Secondary Safety Outcome is frequency of occurrence of device related Adverse Device Events (ADEs), Serious Device Events (SADEs). Measured by asking patient if any adverse events occured since last follow-up. |
At implant surgery, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery)
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Exploratory outcomes - complaints and incidence
時間枠：At implant surgery, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery)
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Rate of complaints and incidents related to the medical device during the whole registry. |
At implant surgery, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery)
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Exploratory outcomes - clinical satisfaction
時間枠：At implant surgery, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery)
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Clinical satisfaction measured on a Likert scale: 1 to 6, with 1 being "not satisfied at all" to 6 being "highly satisfied. |
At implant surgery, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery)
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Exploratory outcomes - patient satisfaction
時間枠：At implant surgery, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery)
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The patient's assessment of function and aesthetics is recorded by his/her assessment of function, aesthetic appearance, implants, speech and self-confidence. The parameters are assessed by rating the degree of satisfaction on a 100 mm Visual Analogue Scale (VAS). |
At implant surgery, 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after implant surgery)
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Mariane Sordi、Z-Systems
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
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。