Treatment of Peri-Implant Mucositis With Standard of Care and Bioptron Hyperlight Therapy: A Parallel-Arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Periodontal chart-Bleeding on probing (BOP)
研究概览
简要总结
Objectives:
The aim of this study was to evaluate in a cohort of patients with peri-implant mucositis: (a) the efficacy of professional mechanical debridement therapy assisted using Bioptron Hyperlight Therapy on the reduction of periodontal indexes (b) the reduction of total oxidative salivary stress.
Material and Methods Forty subjects with a diagnosis of peri-implant mucositis were enrolled in this study and randomly assigned to the study group (mechanical debridement therapy assisted using Bioptron Hyperlight Therapy) or control group (mechanical debridement therapy alone). The study duration was 6 months. Data on plaque index (PI), bleeding on probing (BoP), probing pocket depth (PPD) and pain relief on Visual Analogue Scale (VAS) were recorded at T0, T1 (14 days), T2 (1 month) and T3 (6 months). Group differences were assessed using Student's t-test and Pearson's Chi-squared test of homogeneity
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 30-60 years old.
- •With diagnosis of peri-implant mucositis.
- •Plaque index (PI) ≥ 40%.
- •Al least one implant site with PPD≥4 mm, BOP+ and suppuration.
- •No uncontrolled diabetes, cardiovascular diseases, bone metabolism disorders, no autoimmune diseases (lichen planus, pemphigoid, pemphigus and systemic lupus erythematosus).
- •No pharmacological therapies, no chemo-radiotherapies.
- •No smoking (>10 cigarettes/day), alcohol and/or drug consumption.
- •No pregnancy or breastfeeding.
- •No allergy.
排除标准
- 未提供
研究组 & 干预措施
peri-implant mucositis treated with standard of care-professional mechanical debridement
patients with peri-implant mucositis are treated with standard of care, i.e. professional mechanical debridement
干预措施: Photobiomodulation with Bioptron Hyperlight Therapy (Device)
peri-implant mucositis treated with photobiomodulation in addition to standard treatment
patients with peri-implant mucositis are treated with photobiomodulation in addition to standard treatment
干预措施: Photobiomodulation with Bioptron Hyperlight Therapy (Device)
结局指标
主要结局
Periodontal chart-Bleeding on probing (BOP)
时间窗: Patients were assessed at 24 weeks (T3)
Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is : * 0: normal colour of gingiva, no inflammation, no bleeding; * 1: slight inflammation; no bleeding; * 2: moderate inflammation; presence of bleeding on probing; * 3: severe inflammation; tendency to spontaneus bleeding.
Periodontal chart-Probing pocket depth (PPD)
时间窗: Patients were assessed at 24 weeks (T3)
Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.
Periodontal chart- Plaque index (PI)
时间窗: Patients were assessed at 24 weeks (T3)
Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is : * 0: no visible plaque; * 1: thin plaque layer detectable by scraping; * 2: moderate plaque layer; visible to the naked eye; * 3: abundant plaque layer.
次要结局
- Pain relief(Patients were assessed at 24 weeks (T3))
研究者
Gianna Maria Nardi
Clinical Professor
University of Roma La Sapienza