Aesthetic Evaluation of Two Piece 3mm Implants for Single Tooth Replacement of Maxillary Laterals and Mandibular Incisors
調査の概要
状態
条件
詳細な説明
PURPOSE OF THE STUDY:
The purpose of this research study is to examine the aesthetics (the appearance of the implanted tooth and gums) as well as the soft tissue loss over a three-year period. This study involves replacing a missing small front tooth with a dental implant, abutment, and crown. A titanium dental implant acts as the replacement for a tooth root. An abutment is made of titanium which is either gold or silver in color and cannot be seen; but may affect the way the gum looks. An abutment is the component that attaches the crown to the implant post. A crown (which acts as the tooth replacement) is made of metal and/or porcelain and attaches over the abutment.
The dental implant and the abutments used in this study have been approved by Health Canada and the U.S. Food and Drug Administration (FDA) for the use of replacing the small teeth in the front of the mouth.
The abutment is made in two colors (either gold or silver) and you cannot choose. For each subject this is decided by chance. You will have an equal chance of getting a gold or silver-colored attachment. You will know which color the abutment will be once you have consented to be in the study and registered. You will know the color of the abutment before the implant is placed. The abutment is covered by the crown.
You will be in this study for about three years. There will be approximately 60 subjects who will participate in this study in different centres, in Canada and the USA.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Ontario
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Toronto、Ontario、カナダ、M5R 3K4
- Dr. Suzanne Caudry PhD DDS MSc Perio Implant Dentistry and Periodontics
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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
説明
Inclusion Criteria:
- Capacity to provide written informed consent to participate in the study.
- 18 years or older
Site requirements:
Missing one or both maxillary lateral incisors (if missing both, then both sites must be used in the study) or Single missing mandibular incisor or Two missing mandibular incisors, not adjacent to one another (both sites must be used in the study) Aside from the missing teeth specified above, all other teeth in the sextant must be present.
A minimum of premolar occlusion is required. A minimum mesio-distal and buccal-lingual distance of 5mm is required
Exclusion Criteria:
- Rampant caries or unstable periodontal disease of the remaining dentition.
- Any systemic or local disease or condition that may compromise post-operative healing.
- Long-term use of systemic corticosteroids or other medications that may compromise post-operative healing.
- Present alcohol and/or drug abuse.
- Unable or unwilling to return for follow-up exams over a 3 year period.
- Pregnancy or lactation at time of enrollment.
- Smokers will be excluded from the subject pool.
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
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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Recession
時間枠：every 12 months for 3 years
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The Astra Tech 3.0 mm 2 piece implant can be placed and restored in a 5 mm or greater bone space for a mandibular incisor or maxillary lateral incisor site (minimum 5 mm mesio-distal [side to side] bone width and 5mm bucco-lingual [front to back] bone width) without exhibiting recession of the soft tissue (gingival margin or the interproximal papillae).
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every 12 months for 3 years
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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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Esthetic parameter Scores
時間枠：every 12 months up to three years
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Esthetic parameter scores will be higher when the Atlantis Gold Hue titanium abutment is used in comparison to the Atlantis titanium abutment.
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every 12 months up to three years
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協力者と研究者
捜査官
- 主任研究者：Dr. Suzanne D Caudry, DDS PhD、Implant Dentistry and Periodontics
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
キーワード
その他の研究ID番号
- WIRB® Protocol #20101573
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。