The Caries Prevention Effect of Surface Pre-reacted Glass-ionomer Filler Incorporated in Denture Base Resins on Edentulous Elderly People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Saliva Fluoride Concentration (Part Per Million,Ppm)
研究概览
简要总结
The purpose of this study is to determine whether a novel material of S-PRG fillers containing in a daily-used resin denture base and their capability of fluoride release and recharge to elevate the salivary fluoride level and prevent dental caries in Thai middle-aged patients between 35-60 years of age who wear the resin denture.
详细描述
The study design is a 1.5-year, double blind randomized clinical trial, with 150 volunteers between 35-60 years of age wearing palatal removable partial denture containing with/without S-PRG fillers. This study will be performed in 3 local government hospitals located around Bangkok metropolitan, Ministry of Public Health, Thailand. The subjects will be assigned to the control group; resin denture base containing without S-PRG fillers and the experimental group; resin denture base containing 20% by weight of S-PRG fillers. Two parameters we can measure are; (1) Salivary fluoride level, accessed at different time point; on day 1, 14, 15 and at 3, 12 months after wearing the denture, and (2) Caries incidence using ICDAS-II, taken at 18 months.
Regarding an agreement with the participating dentists and dental assistants in the hospitals, patients in the waiting list of removable partial denture are screened according to our eligible criteria. If they meet eligibility criteria, a complete description is follow:
"If you agree to participate in the study, at today's visit we will ask you some questions about your medical and dental health such as what medication that you are presently taking, and whether you use fluoride supplement except for toothpaste. You do not have to answer every question. The dentist will do a brief examination of your mouth looking to see if you have any decay. You will not be able to participate in this study if you have obvious untreated tooth decay.
Following completion of the questionnaire and examination, we will do a simple test on your saliva. We will collect stimulated saliva by having you to chew a piece of wax for 5 minutes. You will spit all the saliva formed during those 5 minutes into a cup. We will measure the volume of the saliva produced. You will have to have a normal flow rate to participate.
Collecting this information, doing the saliva test, and completing the dental examination will take about 30 minutes of today's appointment. You may refuse to participate in any of the saliva test or answer any question or item in the questionnaire. If that is the case, you will not qualify for the study. If you do qualify and agree to take part, the dentist will take a mold of your mouth to make an upper resin denture to replace your missing teeth for you to wear. This is a routine dental procedure. Some subjects may gag while the mold is being taken for the denture. The dentist has methods to help you control the gagging reflex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions
- •General Health: Good general health with no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with subject safety during the study period
- •Salivary Flow: Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate > 0.15 ml/minute; gum base stimulated saliva flow rate ≥ 1 ml/minute)
- •Oral condition: a) At least 6 teeth remaining natural upper teeth in good condition, including at least 2 posterior teeth. b) Adequate remaining natural or artificial lower teeth for proper function. c) Do not use fluoride supplement excluding toothpaste. and d) Present of caries risk or filling at least 1 surface.
排除标准
- •Exhibited signs of xerostomia
- •Serious oral pathology (e.g. extensive dental caries, periodontal disease)
- •Pregnant or lactating women
- •Frequent mouthwash or fluoride supplement use
- •Unable to have basic self-care ability (including oral hygiene practice)
- •History of allergies, metabolic diseases such as diabetes, or other medical conditions that could interfere with the study.
- •Be caries free in oral cavity
研究组 & 干预措施
PMMA resin & S-PRG filler
A denture base will be made from PMMA resin & S-PRG filler for subject to wear.
干预措施: S-PRG filler (Device)
PMMA resin
A denture base will be made with PMMA resin as a standard material.
干预措施: PMMA resin (Device)
PMMA resin & S-PRG filler
A denture base will be made from PMMA resin & S-PRG filler for subject to wear.
干预措施: PMMA resin (Device)
结局指标
主要结局
Saliva Fluoride Concentration (Part Per Million,Ppm)
时间窗: on days 1, 14, 15, and 3 months and 1.5 years of wearing the denture
Whole mixed saliva was collected by passive drooling into individual plastic vials to a volume of 2 ml while wearing the denture to determine the capacity for fluoride release and recharge from the denture. Saliva fluoride concentrations (ppm) were assessed at multiple time points (baseline, days 1, 14, 15, and 3 months and 1.5 years) to compare with baseline concentration under the conditions that the participants wear the resin denture at least 1 hour and refrain from tooth brushing at least 2 hours before saliva sampling. The salivary fluoride content (ppm) of each solution was determined using a fluoride ion electrode (item number 27502-19, Cole-Palmer, USA) connected to a 710 A plus fluoride ion meter (item number 067952, Thermo Orion, USA).
次要结局
- Assessment of Enamel Caries(Baseline and 1.5 years of follow up)
研究者
Kritirat Kiatsirirote
Dentistry
Thammasat University