Clinical Trial NuSmile Crowns
A Clinical Trial of NuSmile's Pre-Veneered Stainless Steel Crowns and NuSmile ZR Crowns Compared With Strip Composite Crowns in Anterior Primary Teeth -- Pilot Study
調査の概要
状態
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Washington
-
Seattle、Washington、アメリカ、98115
- University of Washington-The Center for Pediatric Dentistry
-
-
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
説明
Inclusion Criteria:
- Patients of record at the University of Washington's Center for Pediatric Dentistry
- Patients in general good health (ASA I)
- Patients aged 5 years old or younger
- Patients in need of at least one preformed crowns, on anterior primary teeth
- Patients undergoing general anesthesia for dental treatment
- Parent or guardian of patient able and willing to provide informed consent
Exclusion Criteria:
- Medically compromising condition
- Teeth with proximal space closures of sufficient magnitude to preclude placement of crown
- Teeth with complete absence of facial or lingual walls following tooth preparation
- Teeth that are expected to be exfoliated/extracted within one year will not participate in the study
- Anterior crowding
- Occlusion class III
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 |
|---|---|
|
アクティブコンパレータ：Nu Smile Zirconia crown
Anterior primary teeth which received a NuSmile zirconia crown as a final restoration
|
Placement of an anterior primary crown restoration
|
|
アクティブコンパレータ：Nu Smile pre veneered crown
Anterior primary teeth which received a NuSmile pre veneered crown as a final restoration
|
Placement of an anterior primary crown restoration
|
|
アクティブコンパレータ：Composite strip crown
Anterior primary teeth which received a composite strip crown as a final restoration
|
Placement of an anterior primary crown restoration
|
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 |
|---|---|---|
|
Fitting
時間枠：12 months
|
The number of teeth scored in the crown fitting categories described below Fitting 0 = Good natural retention
A higher score means a worse outcome |
12 months
|
|
Positioning
時間枠：12 months
|
Change in the following clinical assessment measure between baseline and 12 months using the categories below Positioning 0= Proper position
A higher score means a worse outcome |
12 months
|
|
Proximal Contact
時間枠：12 months
|
The number of teeth scored in the proximal contact categories as described below Proximal contact 0= Open spaces
A higher score means a worse outcome |
12 months
|
|
Marginal Adaptation
時間枠：12 months
|
The number of teeth scored in the marginal adaptation categories as described below Marginal adaptation 0= No discrepancies detected with explorer
A higher score means a worse outcome |
12 months
|
|
Color
時間枠：12 months
|
The number of teeth scored in the color categories described below Color matching 0= Matches completely or within range of shade and translucency
A higher score means a worse outcome |
12 months
|
|
Gingival Status
時間枠：12 months
|
The number of teeth scored in the gingival status categories described below Gingival status 0=Pink, firm, free of inflammation
A higher score means a worse outcome |
12 months
|
|
Retention of the Crown
時間枠：12 months
|
The number of teeth scored in the retention of the crown categories described below Retention of the crown 0= Intact 1= Partially missing 2 = Missing - some cement remaining on both tooth and crown interior A higher score means a worse outcome |
12 months
|
|
Integrity of the Veneer/Composite
時間枠：12 months
|
The number of teeth scored in the integrity of the veneer/composite categories described below Integrity of veneer/ composite 0= Intact
A higher score means a worse outcome |
12 months
|
|
Secondary Caries
時間枠：12 months
|
The number of teeth scored in the secondary caries categories described below Secondary caries 0= Absent 1= Present A higher score means a worse outcome |
12 months
|
|
History of Trauma
時間枠：12 months
|
The number of teeth scored in the history of trauma categories described below History of trauma 0= Absent 1= Present A higher score means a worse outcome |
12 months
|
|
Clinical Pulp Pathology
時間枠：12 months
|
The number of teeth scored in the clinical pulp pathology categories described below Clinical pulp pathology 0= Absent 1= Present A higher score means a worse outcome |
12 months
|
|
Radiographical Pulp Pathology
時間枠：12 months
|
The number of teeth scored in the radiographical pulp pathology categories described below Radiographical pulp pathology 0= Absent 1= Present A higher score means a worse outcome A higher score means a worse outcome |
12 months
|
|
Parent's Esthetic Satisfaction
時間枠：12 months
|
The number of teeth scored in the parent's esthetic satisfaction categories described below Parents esthetic satisfaction via a survey 0=Satisfied 1= Dissatisfied A higher score means a worse outcome |
12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Mariella Garcia, DDS、University of Washington
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
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?
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
米国で製造され、米国から輸出された製品。
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