Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in Periodontal Probing Depths (PD)
研究概览
简要总结
The purpose of the study is to evaluate if using Erbium-doped yttrium aluminium garnet laser, Erbium YAG laser (Er:YAG) laser could have adjunctive benefits to the conventional standard mechanical debridement to ablate the infected tissue around the dental implant and detoxify the contaminated implant surface for resolving peri-implant infection and enhance bone regeneration of peri-implant defects.
详细描述
The purpose of the study is to evaluate if using Er:YAG laser could have adjunctive benefits to the conventional standard mechanical debridement to ablate the infected tissue around the dental implant and detoxify the contaminated implant surface for resolving peri-implant infection and enhance bone regeneration of peri-implant defects.
This study involves one center and a double-blinded randomized controlled clinical trial is planned. Twenty-four adult patients in the need of surgical treatment due to peri-implantitis will be included. Six visits are needed for each patient including a 24 week follow-up visit.
Specific Aim 1: To compare the clinical benefit of Er:YAG laser-assisted peri-implant defect debridement and surface detoxification with conventional mechanical debridement for regenerative therapy
Specific Aim 2: To evaluate whether Er:YAG laser-assisted regenerative surgical therapy can decrease bacterial load and alter microbial profile
Specific Aim 3: To analyze whether Er:YAG laser-assisted regenerative surgical therapy can impact the molecular profile of the peri-implant crevicular fluid (PICF) and the stability of the treatment
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects, aged 18 - 85 years
- •Physical status according to the American Society of Anesthesiologists (ASA) I or II, which includes patients who are systemically healthy or suffer under mild to moderate, but well controlled systemic diseases.
- •Subjects having a minimum of 1 dental implant with peri-implantitis.
- •Dental implants with peri-implantitis ≥ 2 threads exposed (infrabony defect) identified on the radiograph and pocket probing depth (PPD) ≥ 5mm, with bleeding on probing (BOP) and/or suppuration (pus)
- •The implants are in function for at least 6 months
- •Only rough surface implant will be included in this study
排除标准
- •Long-term use of antibiotics > 2 weeks in the past two months
- •Obvious malpositioning of the dental implants
- •Subjects taking medications known to modify bone metabolism (such as bisphosphonates, corticosteroids, Hormone replacement therapy for menopausal women, parathyroid hormone, Denosumab, strontium ranelate)
- •Pregnant females or those planning to become pregnant
- •Subjects with a history of major diseases, oral cancer, sepsis or those having adverse outcomes to oral procedures in the past, will be excluded
- •Mobility of dental implants
- •History of alcoholism or drug abuse
- •Current smokers
- •Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c >8)
- •Uncontrolled systemic disease or condition known to alter bone metabolism, like Osteoporosis, Osteopenia, Hyperparathyroidism, Paget's disease
- •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 24 Week
PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks.
Change in Clinical Attachment Level (CAL)
时间窗: Baseline and 24 Week
CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 24 weeks.
Change in Bleeding on Probing (BOP)
时间窗: Baseline and 24 Week
BOP will be measured dichotomously as 0 or 1. Score 0=no bleeding present Score 1=bleeding present Change in subject BOP score was calculated between baseline and 24 weeks and reported as percent of sites with BOP.
Change in Radiographic Bone Fill (RBF)
时间窗: Baseline and 24 Week
Peri-implant bony defect change will be measured compared to baseline. Participants' standardized radiographs were used to determine bone level changes between baseline and 24 weeks.
次要结局
未报告次要终点
研究者
Chin-Wei Wang
Clinical Assistant Professor
University of Michigan