Safety and Efficacy of NovoMatrix in Gingival Recession Coverage /A Pilot Clinical and Histological Case Series/
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Histology
研究概览
简要总结
Twenty patients seeking treatment for gingival recession coverage, ranging from 20-70 years of age with multiple Miller Class I or II buccal gingival recessions (depth≥3 mm, at least 3 adjacent teeth) will be recruited for this study. Five patients within the study patient pool looking for further orthodontic or restorative treatment that requires removal of one single rooted tooth within the study site of interest will be selected for histological sample removal. All procedures performed in this study will be executed according to established routine protocols, with the exception of block biopsies of one hopeless tooth per patient (total of 5 patients) at 6 months.
详细描述
Patient Selection Ten patients requiring gingival recession coverage (Miller Class I or II with multiple buccal gingival recession ≥3 mm, at least 3 adjacent teeth) will be enrolled and prepared for surgery in accordance with accepted dental practice guidelines (including informed consent). The appropriate demographic and medical history, physical examination and radiographs will be performed and recorded. Other therapies will not be withheld from the patient if the investigator determines that they are appropriate. Any adverse events will be recorded and reported on the appropriate case report form. Any and all complications will be addressed in an appropriate manner at the discretion of the investigator.
Inclusion Criteria
- Male or female, between 20-70 years of age, who request gingival augmentation or recession coverage.
- Subjects who are willing to sign an informed consent, participate and return for follow-up visits.
- Subjects without significant medical history and currently not on medications that might complicate treatment outcomes.
- Subjects demonstrating good oral hygiene (FMPS, FMBS less than 20%).
Exclusion Criteria
- Subjects who do not meet all the inclusion criteria or who will not cooperate with the protocol schedule.
- Subjects who received and failed a previously placed autogenous graft.
- Subjects who have significant untreated periodontal disease, caries, infection or chronic inflammation in the oral cavity within two adjacent tooth positions of the clinical trial area.
- Subjects who have used nicotine-containing products within 3 weeks prior to surgery.
- Subjects who are insulin-dependent diabetic or if their Hgb1c levels > 6.5%.
- Subjects who have had a history of malignancy within the past 5 years (except for basal or squamous cell carcinoma of the skin or in situ cervical carcinoma).
- Subjects who are nursing or pregnant.
- Subjects who are presently taking medications (except estrogen/progesterone therapy) or those who are undergoing treatment that in known to have an effect on bone turnover.
- Subjects who have diseases that affect bone metabolism (excluding idiopathic osteoporosis).
- Subjects with a history of an autoimmune disease, documented allergy or multiple allergies to any component of the agents used in this study.
- Acutely infected mucogingival defect site.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, between 20-70 years of age, who request gingival augmentation or recession coverage.
- •Subjects who are willing to sign an informed consent, participate and return for follow-up visits.
- •Subjects without significant medical history and currently not on medications that might complicate treatment outcomes.
- •Subjects demonstrating good oral hygiene (FMPS, FMBS less than 20%).
排除标准
- •Subjects who do not meet all the inclusion criteria or who will not cooperate with the protocol schedule.
- •Subjects who received and failed a previously placed autogenous graft.
- •Subjects who have significant untreated periodontal disease, caries, infection or chronic inflammation in the oral cavity within two adjacent tooth positions of the clinical trial area.
- •Subjects who have used nicotine-containing products within 3 weeks prior to surgery.
- •Subjects who are insulin-dependent diabetic or if their Hgb1c levels > 6.5%.
- •Subjects who have had a history of malignancy within the past 5 years (except for basal or squamous cell carcinoma of the skin or in situ cervical carcinoma).
- •Subjects who are nursing or pregnant.
- •Subjects who are presently taking medications (except estrogen/progesterone therapy) or those who are undergoing treatment that in known to have an effect on bone turnover.
- •Subjects who have diseases that affect bone metabolism (excluding idiopathic osteoporosis).
- •Subjects with a history of an autoimmune disease, documented allergy or multiple allergies to any component of the agents used in this study.
- •Acutely infected mucogingival defect site.
结局指标
主要结局
Histology
时间窗: 6 months
histologically evaluate the quality of newly formed soft tissues 6 months following gingival recession coverage utilizing NovoMatrix.
次要结局
- Recession depth(Baseline, 1, 3, 6 months and 1 year)
- Papilla-Contact point distance(Baseline, 1, 3, 6 months and 1 year)
- Volumetric changes(Baseline, 1, 3, 6 months and 1 year)
- Recession width(Baseline, 1, 3, 6 months and 1 year)
- Papilla width(Baseline, 1, 3, 6 months and 1 year)
- Postoperative Blood Perfusion changes(Day 0, 1, 4, 7, 10, 14, Month 1, 3, 6)
- Probing Pocket Depth(Baseline, 1, 3, 6 months and 1 year)
- Width of the Keratinized tissue (KTW)(Baseline, 1, 3, 6 months and 1 year)