Double Blinded Randomized Clinical Trial for Evaluation of Resin Modified Glass Ionomer Cement Versus Resin Infiltration in Treating White Spot Lesions
试验速览
- 阶段
- 2 期
- 入组人数
- 35
- 主要终点
- Change in Patient satisfaction
研究概览
简要总结
The aim of this study is to evaluate the addition of new technology of resin modified glass-ionomer in comparison to resin infiltration in treating post-orthodontic white spot lesions; both applies into the same patient's mouth; to reveal which material will have more clinical satisfactory performance inside the oral cavity and to overcome the high expensive cost in treating such clinical cases
详细描述
Roles and responsibilities:
- Shaimaa Mohammed (SH.M.): Operator and author.Specialist in Air-Force Specialized Hospital.
- Mohamed Riad (M.R.): Main supervisor, data monitoring and auditing, Professor, Conservative Dentistry Department,Cairo University.
- Asma Harhash(A.H.):Co-supervisor, outcome assessor and data collection, Associate Professor, Russian University.
- Omnia Magdy Moustafa (O.M.): Baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents: Assistant lecturer, Conservative Dentistry Department , Faculty of Oral and Dental Medicine Cairo University.
- Ghada Ahmed (G.A.): Data entry and auditing; Assistant lecturer, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Russian University.
Intervention:
A- Preoperative clinical assessment:
- Explain patient need toward aesthetic needs
- Digital photos for white spot lesions
- Recording number of white spot lesions and site. (SH.M.) will apply both materials at the same patient mouth (Split mouth technique) according to the manufacturer's instructions.
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, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Post-Orthodontic patients included in this clinical trial toll age of 35 years.
- •Patients with good general health.
- •Patients who will agree to the consent and will commit to follow-up period.
- •Fully erupted anterior teeth with no cavitated lesions.
- •At least one spot lesion on each side in the same jaw
排除标准
- •Patients with any systemic disease that may affect normal healing.
- •Patient with bad oral hygiene.
- •Tetracycline or fluorsis staining.
- •Patients who could/would not participate in all times of follow-up.
- •Untreated periodontal disease was not allowed.
- •Active caries or defective Restorations in 6 anterior teeth.
- •Bleaching history
- •Patients participating in more than 1 dental study.
- •Patient received fluoride varnish during orthodontic treatment.
研究组 & 干预措施
Vanish xt Extended Contact Varnish
Vanish xt Extended Contact Varnish is a resin modified glass ionomer cement and fluoride varnish used to treat white spot lesions to be more resistant to early caries progression.
干预措施: Vanish xt Extended Contact Varnish (Drug)
Resin infiltration
Resin infiltration is a low viscous resin infiltrates into small pores of white spot lesions to block entrance of bacteria into dentinal tubules of the tooth and more resistant to early caries progression.
干预措施: resin infiltration (Drug)
结局指标
主要结局
Change in Patient satisfaction
时间窗: immediately, 1 day, 1week,1 month,3 month,6 month and1 year
using visual analogue scale ruler (0-100 mm) 0 refer to not satisfied at all,100 refer to total satisfied
次要结局
- Change in color change(immediately, 1 day, 1week,1 month,3 month,6 month and1 year)
研究者
Shaimaa Mohamed Mostafa Rohym
Specialist in Air-Force Specialized Hospital, New Cairo
Cairo University