Application of Sticky Bone and Bio-Oss Collagen in Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Changes in horizontal ridge widths
研究概览
简要总结
In this experiment, after non-traumatic tooth extraction, the blank group underwent natural healing, and the Bio-Oss Collagen underwent alveolar ridge preservation using Bio-Oss Collagen and the Sticky Bone group using Sticky Bone, to verify the application of Bio-Oss Collagen and Sticky Bone in alveolar ridge preservation
详细描述
Within 6 months after tooth extraction, the remaining alveolar ridge undergoes varying degrees of absorption, resulting in a decrease in horizontal width and vertical height of the alveolar ridge. The three-dimensional size change of the alveolar socket may affect the implantation of later implants and cause aesthetic and functional problems. Alveolar ridge preservation can maintain the volume of the alveolar socket, prevent soft tissue from growing into undesirable positions, slow down the absorption of the alveolar ridge to some extent, promote new bone formation, and maintain the shape of the extraction socket. This is crucial for later implant treatment for missing teeth. In this experiment, after non-traumatic tooth extraction, the blank group underwent natural healing, and the Bio-Oss Collagen group underwent alveolar ridge preservation using Bio-Oss Collagen and the Sticky Bone group using Sticky Bone, respectively, to verify the application of Bio-Oss Collagen and Sticky Bone in alveolar ridge preservation
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
- None (Participant)
盲法说明
Clinical assessments, semi-quantitative histological analysis, and statistical analysis were performed by examiners who were blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The presence of one adjacent tooth at the extraction site
- •Adequate oral hygiene (plaque index <20%;bleeding on probing <25% )
- •Need for tooth extraction due to endodontic，periapical or periodontal disease.
- •Presence of ≥ 2 mm of keratinized tissue
- •the extraction sockets have no more than 50% of buccal alveolar bone loss(Integrity of alveolar bone walls)
排除标准
- •Pregnancy or lactation
- •Smoking more than 10 cigarettes per day
- •with no evidence of acute infection such as severe swelling, suppuration at the extraction site
- •Uncontrolled periodontal disease
- •Existence of bone metabolic disease
- •history of malignancy, radiotherapy, or chemotherapy in the past 5 years
- •Administration of bisphosphonates
- •long-term use of NSAIDs
- •Alcohol or drug abuse
- •Infectious disease, such as hepatitis or human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome (AIDS)
- •Uncontrolled severe diabetes.( hemoglobin A1c >6.7%)
研究组 & 干预措施
blank group
After non-traumatic tooth extraction, the control group will undergo natural healing.
Sticky Bone group
After non-traumatic tooth extraction, the Sticky Bone group will use Sticky Bone for alveolar ridge preservation
干预措施: alveolar ridge preservation with sticky bone (Procedure)
Bio-Oss Collagen group
After non-traumatic tooth extraction, the Bio-Oss Collagen group will use alveolar ridge preservation with bio-oss collagen
干预措施: alveolar ridge preservation with bio-oss collagen (Procedure)
结局指标
主要结局
Changes in horizontal ridge widths
时间窗: baseline (before the surgery) and six months
Changes in horizontal ridge widths at 1, 3, and 5 mm below the ridge crest
次要结局
- percentages of newly formed bone(six months)
- Postoperative response assessed by the Visual Analogue Scale (VAS) questionnaire(one week post-surgery)
- Changes in thickness of the peri-implant mucosa(at implant placement and one year after crown placement)
- Changes in marginal bone level(at crown placement and one year after crown placement)
- Changes in peri-implant buccal bone thickness(at implant placement and one year after crown placement (T6).)
- Bleeding on probing and probing pocket depth(one year after crown placement)
- Changes in the vertical heights of the ridge(baseline (before the surgery) and six months)
- Thicknesses of the keratinized gingiva(baseline (before the surgery) and six months)
- width of the keratinized gingiva(baseline (before the surgery) and six months)
- percentages of newly formed bone(six months)
- The percentage of residual materials(six months postoperative)
- The bone density ratio(six months postoperative)
- The percentage of in alveolar bone volume within the region of interest (ROI) relative to the volume(at baseline)
- Postoperative response assessed by the Visual Analogue Scale (VAS) questionnaire(2 weeks post-surgery)