Effect of Calcium Fluoride Nanoparticles in Prevention of Demineralization During Orthodontic Fixed Appliance Treatment: a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- DIAGNOdent Pen scores change
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of calcium fluoride nanoparticles containing orthodontic primer in preventing or decreasing the incidence WSLs over a period of 6 months in patients with fixed orthodontic appliances.
This study proposed to be double blinded, split mouth, randomized clinical trial, with equal randomization (1:1 allocation ratio).
详细描述
The sample was selected and recruited from patients attending two centres (Orthodontic Department at Karbala Governmental Specialized Dental Center and Almina Dental Private Clinics/Karbala), but the bonding and follow up sessions were done in Almina Dental Private Clinics/Karbala. Patient recruitment was done according to specified inclusion and exclusion criteria.
Intervention procedure planned to be by bonding fixed orthodontic appliances to all patients. The four quadrants of the mouth will be divided into two groups (Group 1 and 2), with one group, the upper right and lower left quadrants bonded with nCaF2 resin, while the upper left and lower right quadrants bonded with control resin. For the other group, the reverse will be carried out. Then, by the use of a computer random number generator, the two groups will be randomly allocated, and each number in the random table will be given a study number in order to create the final Allocation Table for the participants in the study (which contained the study number and allocation group). the primary planned to be measured by DIAGNOdent Pen 2190 device to measure enamel demineralization objectively, while the secondary objective planned to be quantitative detection of Streptococcus mutans bacteria by using real-time PCR
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study proposed to be double blinded (the patients, investigators and the outcome assessors)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have
- •Fully erupted permanent teeth (regardless the third molar),
- •Indication to have orthodontic treatment without extraction
- •Fair or good oral hygiene before or after oral hygiene instruction
排除标准
- •Patients will be excluded if they had
- •Previous orthodontic treatment or extractions
- •Missing teeth
- •Active enamel caries determined by clinical examination
- •Patients with enamel hypoplasia, dental fluorosis or tetracycline pigmentation
- •Labial restorations
- •Severe periodontal diseases determined according to PDI index by Sigurd P. Ramfjord (Ramfjord, 1967)
- •Craniofacial syndromes such as clefts
- •Xerostomia determined from clinical history of the patient
- •Severely rotated teeth (limiting the appearance of buccal surfaces)
- •Heavy smokers determined by accounting the number of cigarettes per day and time to the first cigarette of the day (Heatherton et al., 1989) .
研究组 & 干预措施
Control primer
Fixed appliance for ten maxillary teeth (contralateral to experimental ten side)and the contralateral mandibular teeth will be bonded using conventional primer (TransbondTM XT orthodontic primers (3M-Unitek, Monrovia, USA)
干预措施: Control primer (Drug)
orthodontic primer containing calcium fluoride nanoparticles
Fixed appliance for ten maxillary teeth and the contralateral mandibular teeth will be bonded using orthodontic primer containing calcium fluoride nanoparticles
干预措施: nCaF2 primer (Drug)
结局指标
主要结局
DIAGNOdent Pen scores change
时间窗: Six months
assessing changes in the amount of enamel demineralization (DIAGNOdent Pen scores) between four time points:- 1. baseline (before brackets bonding) 2. after one month of brackets bonding 3. after three months of brackets bonding 4. after six months of brackets bonding
次要结局
- Streptococcus mutans load change(Six months)
研究者
Rawof Rasheed Jawad
Assistant professor
University of Baghdad