Treatment of Advanced Periodontitis Using an Oscillating Chitosan Device With or Without a Chitosan Gel - a Randomized Parallel Arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bleeding on Probing change
研究概览
简要总结
In the here suggested study, the aim is to test non-surgical treatment of advanced periodontal disease with a chitosan brush with or without chitosan gel in patients with advanced periodontal disease having responded poorly to a more conventional treatment strategy, with the aim to hinder the progression of bone loss around the teeth.
详细描述
Labrida GeliX Chitosan gel 4% (LABRIDA AS, Oslo, Norway) is a chitosan gel. Labrida GeliX Chitosan gel 4% consists of water, chitosan (4%) and lactic acid (2%) and with pH 3.86. In this study GeliX Chitosan gel 4% shall be tested as an adjunct to mechanical debridement of infected tooth surfaces affected by periodontal disease and which have responded poorly to conventional treatment.
Hypotheses and study objectives
Null hypothesis and alternate hypothesis
H0:
There will be no significant difference in reduction in parameters of periodontal inflammation between the test and control groups after 6 and 12 months.
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, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with at least 3 teeth but less than 8 teeth with advanced periodontal attachment loss.
- •Clinical Attachment Loss (CAL) ≥5 mm, probing pocket depth (PPD) ≥5mm and ≤8 mm and inflammation as demonstrated by a modified Bleeding on Probing (BoP) grade 2 (line) or 3 ("spontaneous").
排除标准
- •Ongoing radiotherapy, ongoing chemotherapy, pregnant or nursing patients, prosthetic factors making access to clinical measurements impossible
- •Poor oral hygiene with plaque at >20% of the surfaces
- •Periodontal pockets reaching to the apex of teeth.
- •Teeth with active peri-apical pathology
- •Teeth with root resorption as seen on radiographs
- •Teeth with prosthodontic technical complications should be excluded or treated before inclusion (e.g., overhangs, open contacts with food impaction)
- •Teeth with pockets from other reasons than periodontal disease
- •Teeth with traumatic occlusion should be excluded or treated before inclusion (i.e., fremitus)
- •Patients diagnosed with Periodontal disease grade C i.e., rapid rate of progression
- •Sites in direct proximity with site(s) where patient places snuff (Copenhagen) will be excluded
研究组 & 干预措施
Test
Curettes+ Ultrasonic scalers supragingivally and a chitosan brush in oscillating handpiece subgingivally with adjunct 4% chitosan gel (pH 3.48).
干预措施: 4% chitosan gel (pH 3.48). (Device)
Control
Curettes+ Ultrasonic scalers supragingivally and a chitosan brush in oscillating handpiece subgingivally
干预措施: Reciprocal Chitosan brush (Device)
结局指标
主要结局
Bleeding on Probing change
时间窗: 12 months
Change in periodontal inflammation measured with the inflammation surrogate marker Bleeding on Probing using a categorial scale (modified Bleeding on Probing index (mBoP: 0, 1, 2, 3)) and
Pocket Probing depths change
时间窗: 12 months
Difference between test and control sites in Probing Pocket Depth (PPD)4 weeks , 3 months, 6, 9 and 12 months after baseline.
次要结局
未报告次要终点
研究者
Caspar Wohlfahrt
Head of Research and Development
Labrida AS