GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery
2020年8月27日 更新者：Sunstar Americas
A Randomized, Double-Blind, Controlled, Multicenter Dose Verification Clinical Trial to Evaluate the Safety and Effectiveness of GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery
GUIDOR Growth Factor Enchanted Bone Graft Substitute (GFeBGS) when used in periodontal surgery will shown greater gum and bone regeneration when compare to bone graft substitute alone.
Also, to find the optimal dose.
調査の概要
状態
完了
詳細な説明
This will be a prospective, randomized, double-blinded, controlled, multi-center, dose-verification clinical study in subjects who require surgical intervention to treat a qualifying periodontal defect.
Subjects 25 years and older with advanced periodontal disease in at least one site requiring surgical treatment to correct a bone defect.
研究の種類
介入
入学 (実際)
88
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294
- University of Alabama at Birmingham
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California
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Fullerton、California、アメリカ、92835
- Regenerative Solutions
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Colorado
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Aurora、Colorado、アメリカ、80012
- Drs. McClain and Schallhorn
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Michigan
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Ann Arbor、Michigan、アメリカ、48106
- University of Michigan
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Texas
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Houston、Texas、アメリカ、77063
- Perio Health Professionals
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San Antonio、Texas、アメリカ、78229
- University of Texas Health Science Center at San Antonio
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
25年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Male or female, age of 25 and older
- Must have read, understood, and signed a consent form
- Must be able and willing to follow study procedures and instructions
- Must have undergone thorough scaling and root planing of the target tooth and be expected to demonstrate good plaque control after instruction in oral hygiene
The target tooth must exhibit the following:
- A pocket depth of 7 mm or greater
- After surgical debridement, 4 mm or greater intrabony defect with at least 1 bony wall
- Sufficient keratinized tissue to allow complete tissue coverage of the defect
- Radiographic base of defect at least 3 mm coronal to the apex of the tooth
Exclusion Criteria:
- Failure to maintain adequate oral hygiene during the screening phase
- Women of child-bearing potential
- A history within the last 6 months of HIV, Type IV heart disease, or end-stage renal disease
- A history of oral cancer or any other cancer (exception: subjects with a history of skin cancers such as squamous and basal carcinoma with end of treatment at least 6 months ago and/or prostate cancer with end of treatment at least 5 years ago may be enrolled)
- A history within 12 months of previous open flap periodontal surgery on the study tooth.
- A diagnosis of pre-malignant oral lesion(s)
- A traumatic occlusion of the target tooth
- Target "study" tooth exhibiting Grade III mobility
- Maxillary molars or maxillary first premolar with a prominent mesial concavity
- Study tooth exhibiting a Class II or greater furcation defect
- Clinical or radiographic signs of untreated acute or chronic periapical infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cervical enamel projections not easily removed by odontoplasty, untreated carious lesions at the cemento-enamel junction (CEJ) or on the root surface, or restorations with open or otherwise defective margins at or below the CEJ
- A history within the last 6 months of the daily use of any tobacco products besides cigarettes (smokeless chewing tobacco, pipe or cigar smoking), or of smoking more than 10 cigarettes per day
- Subjects participating in other clinical trials within 30 days of enrollment
- Subjects having uncontrolled endocrine-induced diseases (e.g. uncontrolled diabetes mellitus and hyperparathyroidism)
- Subjects undergoing current therapy with systemic steroids or other drugs that significantly alter bone metabolism
- Subjects with Localized Juvenile Periodontitis (LJP) sites in the oral cavity
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：beta-tricalcium phosphate alone
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実験的：GFeBGS 0.1%
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
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実験的：GFeBGS 0.3%
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
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実験的：GFeGBS 0.4%
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
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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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Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements
時間枠：6 months post-surgery
|
The primary effectiveness endpoint is a composite endpoint that considers radiographic and clinical measurements at six months post-implantation: the amount of linear bone growth (LBG), which is assessed with the use of radiographs, and the regain from baseline of clinical attachment level (∆CAL), which is assessed clinically.
Linear bone growth (LBG) in a vertical and horizontal direction is determined radiographically at six months post-implantation.
The clinical attachment level (CAL) is the distance from the cemento-enamel junction (CEJ) (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket.
The success criteria are ΔCAL ≥1.5 mm and LBG ≥1 mm at 6 months after the treatment.
Both the ∆CAL and LBG must meet the success criteria for a subject to be considered a success.
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6 months post-surgery
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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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Change in Clinical Attachment Level at 3 Months
時間枠：Baseline and 3 months post-surgery
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The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket.
Change = (3 months measurement - Baseline measurement)
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Baseline and 3 months post-surgery
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Change in Clinical Attachment Level at 6 Months
時間枠：Baseline and 6 months post-surgery
|
The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket.
Change = (6 months measurement - Baseline measurement)
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Baseline and 6 months post-surgery
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Linear Bone Growth at 6 Months
時間枠：Baseline and 6 months post-surgery
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Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months.
Linear Bone Growth = (Baseline measurement - 6 months measurement)
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Baseline and 6 months post-surgery
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Percent Bone Fill at 6 Months
時間枠：Baseline and 6 months post-surgery
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Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months.
Percent Bone Fill is calculated by dividing Linear Bone Growth at 6 months by bone height at baseline.
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Baseline and 6 months post-surgery
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Pocket Depth Change at 3 Months
時間枠：Baseline and 3 months post-surgery
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Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes.
Pocket Depth Change = (3 months measurement - Baseline measurement)
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Baseline and 3 months post-surgery
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Pocket Depth Change at 6 Months
時間枠：Baseline and 6 months post-surgery
|
Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes.
Pocket Depth Change = (6 months measurement - Baseline measurement)
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Baseline and 6 months post-surgery
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Change in Gingival Recession at 3 Months
時間枠：Baseline and 3 months post-surgery
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Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes.
Gingival Recession = (3 months measurement - Baseline measurement)
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Baseline and 3 months post-surgery
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Change in Gingival Recession at 6 Months
時間枠：Baseline and 6 months post-surgery
|
Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes.
Gingival Recession = (6 months measurement - Baseline measurement)
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Baseline and 6 months post-surgery
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：David L. Cochran, DDS, PhD、University of Texas Health Sciences Center at San Antonio
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年10月1日
一次修了 (実際)
2014年8月1日
研究の完了 (実際)
2014年8月1日
試験登録日
最初に提出
2012年11月1日
QC基準を満たした最初の提出物
2012年11月16日
最初の投稿 (見積もり)
2012年11月20日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月17日
QC基準を満たした最後の更新が送信されました
2020年8月27日
最終確認日
2020年8月1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。