The Impact of the Adequacy of Keratinized Mucosa on Peri-implant Tissue Health and Patient-reported Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Width of Keratinized Mucosa, KMW
研究概览
简要总结
This study aims to conduct a cross-sectional study to compare the differences in clinical indices, patient-reported outcomes, and levels of inflammatory factors in peri-implant gingival crevicular fluid between sites with adequate (≥ 2 mm) and inadequate (< 2 mm) keratinized mucosa after implant restoration, in order to explore the impact of the presence of keratinized mucosa on peri-implant soft and hard tissue health.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 to 70 years (inclusive of 18 and 70 years), of any gender;
- •Patients who have undergone dental implant restoration 是（single crown or fixed bridge restorations） at the Stomatology Hospital, Zhejiang University School of medicine and have had their final restoration for at least 6 months;
- •Patients who voluntarily participate and sign the informed consent form after being fully informed, and who cooperate with relevant examinations.
排除标准
- •Patients who are unwilling to participate in the follow-up of this study for various reasons
结局指标
主要结局
Width of Keratinized Mucosa, KMW
时间窗: on the day of enrollment
Plaque Index(PI)
时间窗: on the day of enrollment
Bleeding on Probing(BOP)
时间窗: on the day of enrollment
Peri-implant Probing Depth(PPD)
时间窗: on the day of enrollment
Marginal Bone Loss(MBL)
时间窗: The X-ray examination will be completed on the day of enrollment
Patient Satisfaction
时间窗: on the day of enrollment
visual analogue scale \[VAS\] 0-10,e.g., not at all satisfied to perfectly satisfied
Immunological parameters in peri-implant crevicular fluids(PICF)
时间窗: The PICF will be collected on the day of enrollment
PICF samples were collected from buccal aspects of implants after removing all supragingival plaque. The levels of IL-1β and PGE2 in PICF were measured using a sandwich ELISA kit.
次要结局
未报告次要终点