The Influence of Mucosa Tissue Thickness on Marginal Bone Loss of Implants With Smooth Collars: A Prospective Controlled Trial
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
- Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.
研究概览
简要总结
The primary objective of this study is to compare the amount of implant marginal bone loss radiographically and probing depth in between thin and thick mucosa group that will receive a machined collar implant.
Null hypothesis is mucosa thickness does not affect implant marginal bone loss on implant with smooth collar.
详细描述
Twenty eight adult patients who fulfill the inclusion criteria will be divided into 2 groups based upon the mucosa thickness (<2 mm and ≥2 mm). A signed written informed consent will be obtained from all subjects. Subjects will not be screened or treated until an informed consent has been obtained. Patient information will be protected according to the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).
The enrolled patients will receive implants with 1 mm polished collar. Implants will be restored at 4 (±1) months after placement. Outcome analyses will be performed until 1 (±1 month) year after loading and clinical and radiographic parameters will be evaluated to compare clinical outcomes between groups. The primary outcome is implant marginal bone loss and probing depth from clinical and radiographic measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Male or Female
- •In need of one dental implant in the Maxillary or Mandibular area, can be an anterior, premolar, or 1st molar tooth
- •Natural adjacent teeth
- •Bone height of ≥10mm
- •Bone width of ≥5mm
- •Good oral hygiene
- •Stable periodontium
- •Willingness to fulfill all study requirements
排除标准
- •Need bone augmentation
- •Need one dental implant that is a 2nd or 3rd molar tooth
- •Current smoker or quit smoking less than one year
- •Pregnant or plan to get pregnant
- •Uncontrolled diabetes (HbA1C > 7)
- •Medical conditions that may influence the outcome of the study (neurologic or psychiatric disorders, systemic infections )
- •Current use of oral bisphosphonates
- •History of IV bisphosphonates
- •History of radiation therapy in the head and neck area within 4 years
- •Poor oral hygiene (plaque score more than 40% based on O'Leary plaque score)
- •Once a group has been filled, subjects who meet the criteria of that group will be excluded
结局指标
主要结局
Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.
时间窗: 12 months
Radiographic change in remaining bone level (measured in millimeters) between the surgery visit (baseline) and the 12 month follow up visit.
Peri-implant Probing Depth Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.
时间窗: 12 months
Change in probing depths (measured in millimeters) around the dental implant between the crown delivery visit and the 12 month follow-up visit.
次要结局
未报告次要终点
研究者
Hom-Lay Wang, DDS, MSD, Ph D
Professor of Dentistry and Director of Graduate Periodontics
University of Michigan