Analysis of the Effectiveness of the Use of Glycine Powder and Angled Implant Brush in Oral Hygiene Maintenance in Patients Reinstated With Columbus Bridge ProtocolTM: a Factorial Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Denture Plaque Index (DPI)
研究概览
简要总结
This study aims at comparing different procedures of Professional Oral Hygiene (POH) and Domiciliary Oral Hygiene (DOH) in Columbus Bridge ProtocolTM full-arch reinstated patients by dividing a sample of at least 74 patients into 4 groups with a 1:1:1:1 ratio. The patients will randomly be assigned to a "Standard" or "Glycine Perio Flow" Professional treatment, and to a "Standard" or "Angled" Toothbrush for their Domiciliary oral hygiene.
Data about bacterial plaque presence is collected both before and after unscrewing the denture, when it comes to implant abutments. Instead, Denture Plaque Index will be collected after unscrewing the denture, by means of erythrosine and analyzed using a specific software that allows to compute the percentage of plaque on the denture.
Patients will be seen after 3 months in order to figure out differences between DOH groups, by measuring plaque on abutments and on the denture after unscrewing it.
At the moment there are no scientific studies trying to determine which professional and domiciliary procedures might be more efficient to control bacterial plaque in Columbus Bridge ProtocolTM reinstated patients.
Statistically significant lower Plaque Index (PI) and Denture Plaque Index (DPI) scores are expected in patients treated with glycine perio flow, compared to standard treated patients. However, when it comes to angled toothbrush, lower PI and DPI are expected not to be statistically significant.
Expectation from this study is to get information on how to improve full-arch patients' therapy in order to reduce peri-implant diseases which are related to bacterial plaque.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >= 18years
- •Good systemic health, with ASA classification <= 2
- •Columbus Bridge ProtocolTM reinstation from at least six months
排除标准
- •Heavy smokers (>= 10 cigarettes per day)
- •Pregnancy or breastfeeding
- •Autoimmune diseases with or without oral involvement
- •Biological complications on at least one of the dental implants
- •Perimplantits diagnosis, defined according to Lindhe et al's criteria [5]
- •Radicular bone <4mm, evaluated by means of RX
- •Use of gingival overgrowth inducing drugs
- •Cognitive or motor impairments
- •Full-arch reinstations performed in other structures
- •Respiratory issues
- •Infective diseases
结局指标
主要结局
Denture Plaque Index (DPI)
时间窗: T1: second session, after 3 months (for domiciliary oral hygiene).
This study's primary outcome is the plaque index on the denture (DPI). Plaque indexes will be determined by means of erythrosine (GC Tri Plaque ID GelTM, Tokyo, Japan). Pictures in jpg format will be taken with a digital Nikon D80 camera with 105mm macro lens and processed with ImageJ 1.45s software (National Institutes of Health, Bethesda, MD, USA). Pictures will be converted into binary monochrome images. Specific standard thresholds will be determined to differentiate the plaque pixels (blue) from the plaque free ones (pink). This procedure is already proven by literature.
次要结局
- Probing Depth (PD);(T1: second session, after 3 months (for domiciliary oral hygiene).)
- Plaque Index on implant abutments(T1: second session, after 3 months (for domiciliary oral hygiene).)
- Bleeding on Probing (BoP);(T1: second session, after 3 months (for domiciliary oral hygiene).)
研究者
Crupi Armando
Principal investigator
A.O.U. Città della Salute e della Scienza