Comparison of Bond Failure with Resin-modified Glass Ionomer Cement and Visible Light-cure Composite Bonding Material in Adult Orthodontic Patients - a Split-Mouth, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Bracket bond failure
研究概览
简要总结
In this split mouth study design, 34 orthodontic patients coming for fixed appliance treatment will be bonded with standard light-cure composite bonding material and intervention of Resin Modified Glass Ionomer Cement (RMGIC). Contralateral quadrants will be allocated randomly for either RMGIC or visible light-cure composite bonding in both upper and lower jaw.
Quadrant 1: Randomly selected, contralateral upper and lower quadrants from central incisor to second premolar will be bonded with RMGIC bonding system.
Quadrant 2: Randomly selected, contralateral quadrants from central incisor to second premolar will be bonded with visible light-cure composite bonding material.
Allocation of diagonally opposite quadrants by either bonding system will be assigned randomly. Quadrants to be bonded with Resin-modified glass ionomer cement and light-cure composite bonding material will be switched from patient to patient to ensure randomization. This study is single blinded. The study investigators will not be blinded while the patient will be kept blinded.
On the first visit, a specially designed consent form will be signed by the participant.
Patient interaction for the purpose of study will only be for 1 hour duration while bonding of brackets. After six months amount and location of bond breakages will be evaluated from orthodontic record files.
This study will help us evaluate bond strength of RMGIC as compared to light cure composite. RMGIC can also be considered as the choice of material for bonding in high risk caries patients.
详细描述
MATERIAL & METHODS:
Study Design: Experimental study (Randomized Control Trial) Settings: Dental clinics, The Aga Khan University Hospital, Karachi (AKUH) Duration of Study: Patients will be recruited in this study for one and half hour. Chart analysis of these patients will then be done after six months of recruitment.
Sample Size:
Sample size was calculated with OpenEpi (version 3.01) sample size calculator using findings of Hegarty and Macfarlane14 who reported a bond failure percentage of 30% with light-cure adhesive and risk ratio of 2.6 (1.7, 3.9) for RMGIC as compared to resin based light cured composite. Keeping the above risk ratio at level of significance (α) 5% and power of study (1-β) 80%, at least 34 subjects were required for our study. The sample size will be inflated by 10% to account for sample attrition; therefore, a total of 37 subjects will be included in the study.
Sampling Technique: Non-probability consecutive sampling
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 12-35 years
- •Patients with fair to good oral hygiene who have no significant sign of gingivitis
- •Healthy patients with no co-morbids such as rheumatic fever, blood dyscrasias, congenital heart disease, or diabetes mellitus
- •Patients with class I, II and III malocclusions
排除标准
- •Enamel surface defects
- •Pregnant patients or lactating mothers
- •Syndromic patients
- •Subjects with previous history of orthodontic
结局指标
主要结局
Bracket bond failure
时间窗: Three months
The objective of this study is to compare rate of bond failures with Resin-modified glass ionomer cement and visible light-cure bonding.
次要结局
未报告次要终点
研究者
Rashna Hoshang Sukhia
Associate Professor, Program Director
Aga Khan University Hospital, Pakistan