Soft Tissue Stability of Immediate Implant Placement With and Without Immediate Provisionalization: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Linear changes of gum tissue architecture
研究概览
简要总结
This research is studying gum tissue stability of dental implants placed at same appointment as the tooth extraction, with or without a provisional (temporary) crown.
详细描述
This study aims to find out whether a new type of hybrid dental implant-which has a smooth surface near the gums to make cleaning easier and potentially lower the risk of infection-can help improve gum health and reduce implant complications. It also compares two common treatment approaches after tooth removal: placing a temporary provisional crown immediately versus using a standard healing cap. By studying these options, we hope to learn which method provides better healing, protects the gums more effectively, and leads to fewer problems around the implant.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Physical status according to the American Society of Anesthesiology (ASA) I or II, which include patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
- •Periodontally healthy or with treated periodontitis with good oral hygiene ((FMPS) and (FMBS) ≤15%, measured at four sites per tooth).
- •Presence of one non-restorable maxillary anterior tooth (from #5 to #12 sites)
- •More than 20 occluding teeth with stable occlusion.
- •Nonsmokers or smokers < 10 cig/day (self-reported).
排除标准
- •Presence of uncontrolled or untreated periodontal disease.
- •Presence of active periapical infection.
- •Subjects taking medications known to modify bone metabolism or those that can interfere with the normal wound healing (such as bisphosphonates, corticosteroids, hormone replacement therapy, parathyroid hormone, denosumab, strontium ranelate, etc.), or those with uncontrolled systemic diseases or conditions that may similarly affect the patient's healing (osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, uncontrolled diabetes (HBA1c > 8)).
- •Pregnant subjects or individuals attempting to get pregnant (self-reported)
- •Subjects smoking 10 or more cigarettes a day, or those with a history of drug or alcohol abuse (self-reported)
- •Subjects unable to maintain adequate oral hygiene
- •Insufficient restorative space or bite collapse.
- •Lack of primary implant stability assessed intrasurgically.
结局指标
主要结局
Linear changes of gum tissue architecture
时间窗: 1 month and 4 months after baseline surgery, 6 months and 12 months after crown delivery
Digitally measured soft tissue changes in mm\^2 using intraoral and CBCT scans
Volumetric changes of gum tissue architecture
时间窗: 1 month and 4 months after baseline surgery, 6 months and 12 months after crown delivery
Digitally measured soft tissue changes in mm\^3 using intraoral and CBCT scans
次要结局
- Changes in marginal bone(5 months after baseline surgery, 6 months and 12 months after crown delivery)
- Patient-reported satisfaction(14 days after baseline surgery)
- Microbial profile(Baseline, 4 months after baseline surgery, 6 months and 12 months after crown delivery)
研究者
Hom-Lay Wang, DDS, MSD, Ph D
Collegiate Professor of Periodontics and Professor of Dentistry
University of Michigan