Amnion-Chorion Allograft Barrier Used for Root Surface and Guided Tissue Regeneration for Periodontal Intrabony Defects and Grade II Furcation Defects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Probing Depth Change
研究概览
简要总结
The purpose of this pilot project is to evaluate the efficacy of application of Amnion-Chorion allograft membrane on the root surface of periodontally diseased teeth in conjunction with bone substitute covered by Amnion-Chorion allograft in a combination Guided Tissue Regeneration (GTR) treatment of periodontal intrabony and furcation defects.
详细描述
Patients who are referred to the Graduate Periodontics Clinic at Indiana University School of Dentistry for the treatment of severe chronic/aggressive periodontitis will be screened for possible participation in this study. Up to 20 subjects will be accepted into this study.
Written informed consent and authorization will be obtained from all participants and they will be given a copy of the signed informed consent documents.
The procedures listed below are all within standard care for a regenerative therapy around the teeth except the application of the membrane on the root surface prior to the bone grafting. No data collected for this study will be taken from sources outside of that already recorded for standard of care procedures.
Clinical Measurements A single calibrated examiner will perform clinical baseline and 6-month follow up measurements. O'Leary plaque score will be assessed. Six sites of each tooth of probing depth (PD), recession (REC) and clinical attachment level (CAL) will be recorded to the nearest millimeter with a University of North Carolina Probe (UNC Probe). For Glickman grade II furcation defects, in addition to the previous measurements, vertical probing pocket depth (VPD) and horizontal probing depth (HPD) will be measured.
Radiographic assessment will be performed with vertical bite-wing radiographs at baseline and 6-month post-surgical treatment. In order to maximize the standardization of the angulation of radiographs, bite registration will be taken prior to the first radiograph and utilized with beam-guiding device. It will be stored to be used post operatively. Sirona Dental Systems© with 7mA 60kV with 0.16s exposure time will be utilized for all radiographs. Digital #2 films manufactured by Air Techniques Inc. will be used for radiographic assessment. Bony defect (BD) will be defined as the most coronal point where the periodontal ligament space showed a continuous width. If several bony contours could be identified, the most apical one that crossed the root will be defined as the boney defect and the most coronal one as alveolar crest. If the cemento-enamel junction (CEJ) was destroyed by the restorative treatment, the margin of the restoration will be taken as a landmark. Beam guided device will be used as a calibration of measurements. The change of bone fill and angulation will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA class I or II;
- •age >18 years old;
- •Non-smoker;
- •diagnosis of chronic or aggressive periodontitis previously treated with nonsurgical mechanical debridement; 5) patients have at least one two-wall intrabony defect in interproximal areas with radiographic evidence of an intrabony component of ≥ 4 mm, PPD ≥ 6 mm with 1-wall or 2-wall or combination of those defects;
- •Glickman Grade II furcation involvement on buccal of mandibular or maxillary first or second molars without soft tissue exposure of furcation entrance; 7) tooth mobility Miller Grade <1; 8) more than 2mm of keratinized tissue with those selected teeth.
排除标准
- •did not meet all inclusion criteria;
- •pregnancy or nursing woman;
- •subjects with active systemic or localized infection (exclude chronic periodontitis);
- •poor compliance or failure to maintain good oral hygiene as ascertained by the presence of full-mouth plaque score ≥ 20%;
- •restorations or caries on root surfaces or untreated endodontic infections;
- •participants received periodontal surgical treatment on the same site of this study within 2 years;
- •use of systemic or local antibiotics on the anticipated surgical sites during the past 3 months.
结局指标
主要结局
Probing Depth Change
时间窗: Baseline and 6 months
Probing depth was measured at intrabony defect following surgical procedure.
Clinical Attachment Change
时间窗: Baseline and 6 months
Clinical Attachment is defined as the sum of probing depth and gingival recession. The amount of gain of attachment level will be measured.
次要结局
未报告次要终点
研究者
Yusuke Hamada
Clinical Assistant Professor
Indiana University