Therapeutic Peri-implant Maintenance with Laser Therapy: an Extension of the LARST Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Periodontal Probing Depths (PD)
研究概览
简要总结
The present study represents an extension of the previously concluded randomized clinical trial "Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis" (HUM00124386). The aim of the study is to compare the adjunctive effect of laser over mechanical debridement alone in the maintenance of peri-implant tissues after surgical treatment of peri-implantitis (gum disease around implants).
详细描述
The same 24 subjects, previously treated with surgical regenerative treatment of peri-implantitis following the LARST protocol, will be invited to return for three follow-up visits. During the follow-up visits, clinical measurements, x-rays, and pictures of the inside of their mouth will be taken to evaluate the success of their peri-implantitis treatment. If needed, additional laser treatment of the dental implant may also be provided according to the same randomization of subjects in the original study. No placebo laser application will be provided.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who were previously enrolled subjects in the randomized clinical trial of laser-assisted regenerative surgical therapy
排除标准
- •Unable to reach the subject
- •The implant is mobile or lost
- •Premature Exclusion Criteria:
- •The researcher believes that it is not the best interest of the subject to stay in the study
- •If the subject becomes ineligible to participate based on the exclusion criteria
- •If the subject's medical condition requires interventions which preclude involvement in the study (radiation therapy, chemotherapy, etc.)
- •If the subject does not follow study related instructions
- •The study is suspended or canceled.
结局指标
主要结局
Change in Periodontal Probing Depths (PD)
时间窗: Baseline and 6 months
PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks
次要结局
- Change in marginal bone level (MBL)(Baseline and 6 months)
- Change in Clinical Attachment Level (CAL)(Baseline and 6 months)
研究者
Chin-Wei Wang
Clinical Assistant Professor of Dentistry
University of Michigan