GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery
2020년 8월 27일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
88
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama at Birmingham
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California
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Fullerton, California, 미국, 92835
- Regenerative Solutions
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Colorado
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Aurora, Colorado, 미국, 80012
- Drs. McClain and Schallhorn
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Michigan
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Ann Arbor, Michigan, 미국, 48106
- University of Michigan
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Texas
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Houston, Texas, 미국, 77063
- Perio Health Professionals
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San Antonio, Texas, 미국, 78229
- University of Texas Health Science Center at San Antonio
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
25년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: beta-tricalcium phosphate alone
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실험적: GFeBGS 0.1%
GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
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실험적: GFeBGS 0.3%
GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
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실험적: GFeGBS 0.4%
GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements
기간: 6 months post-surgery
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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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Clinical Attachment Level at 3 Months
기간: 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
기간: Baseline and 6 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 = (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
기간: 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
기간: 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
기간: 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
기간: Baseline and 6 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 = (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
기간: 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
기간: Baseline and 6 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 = (6 months measurement - Baseline measurement)
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Baseline and 6 months post-surgery
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: David L. Cochran, DDS, PhD, University of Texas Health Sciences Center at San Antonio
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 10월 1일
기본 완료 (실제)
2014년 8월 1일
연구 완료 (실제)
2014년 8월 1일
연구 등록 날짜
최초 제출
2012년 11월 1일
QC 기준을 충족하는 최초 제출
2012년 11월 16일
처음 게시됨 (추정)
2012년 11월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 9월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 8월 27일
마지막으로 확인됨
2020년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
치주질환에 대한 임상 시험
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University of Pennsylvania완전한Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410의 주진단 또는 이차진단 코드가 있는 환자(5번째 숫자가 2인 경우 제외)미국