Valuation of Bone Volume Changes After Socket Preservation Using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal Compared to Natural Healing After Tooth Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- socket width mm
研究概览
简要总结
Evaluation of Bone volume Changes after socket preservation using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal compared to natural healing after tooth extraction
详细描述
In the last decade dental implants have become widely used for oral rehabilitation. But, the usage of dental Implants might be difficult in cases of alveolar bone deficiencies.
Different ridge preservation techniques were successfully used, using membrane with or without bone substitutes.new grafting material is Mucograft Seal, a collagen matrix graft, which originally used as an alternative to the connective tissue graft for the treatment of gingival recessions. Mucograft has demonstrated a good tissue reaction with high biocompatibility and a low shrinkage tendency, in order to increase the amount of keratinized gingiva in the augmented area.
Study Hypothesis: The observed changes in ridge dimensions when using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal as ridge preservation will be less pronounced in comparison to natural healing after tooth extraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent.
- •Patients of 18 years or older.
- •Patients in need of a tooth extraction in the area of premolars, canines or incisors due to periodontal and/or dental reasons, provided that the socket walls are intact (bone dehiscence of max. 4mm limited to one bone wall).
- •Patients who need implant placement at the site of extraction.
排除标准
- •Inability to complete or understand the informed consent process.
- •Bone dehiscence at extraction socket of more than 4 mm or 4 mm at more than one bony wall.
- •Pregnant or lactating women.
- •Patients who use medications that affect bone metabolism such as IV bisphosphonates.
- •Heavy smokers (more than 10 cigarettes per day).
- •Patients with removable prosthesis, which might compress the treated site.
结局指标
主要结局
socket width mm
时间窗: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
The socket width (buccal-lingual aspect) will be assessed at the following reference points: 1. 3-(∆ACH pre-post) millimeters apical to the alveolar crest, where the buccal and lingual walls are intact. 2. 5-(∆ACH pre-post) millimeters apical to the alveolar crest, where the buccal and lingual walls are intact. 3. The width of each cortical buccal and lingual bone plate, 3 millimeters apical to the alveolar crest. 4. The width of each cortical buccal and lingual bone plate, 5 millimeters apical to the alveolar crest.
keratinized tissue mm
时间窗: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
In the lower jaw the keratinized tissue width will be measured from the apical part of the stent to the mucogingival line on the buccal and lingual sides. On the upper jaw only the keratinized tissue on the buccal side will be measured.
alveolar height mm
时间窗: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
Alveolar crest height (ACH) will be measured from the apical part of the stent to the bone crest at the mid M-D distance of the socket.
次要结局
未报告次要终点