The Effect of Light Curable Resin Modified Glass Ionomer Varnish on Inhibiting the Progression of Non-Cavitated Proximal Carious Lesions: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Clinical progression of non-cavitated proximal carious lesions measured using ICDAS 12 months after treatment
研究概览
简要总结
The standard-of-care preventive measures to stop early tooth decay from becoming worse is by fluoride application, diet counseling, and oral hygiene instructions. This standard way is not always successful. The purpose of this study is to compare standard-of-care preventive measures to stop further tooth decay to standard-of-care preventive measures in addition to a light curable resin modified glass ionomer (RMGI) varnish material (Vanish XT). The material is used for root surface sensitivity treatment, site specific protective coating for newly erupted teeth and other tooth surfaces including early tooth decay.
To be in this study the child must be five to eight years old, medically healthy, attending the Pediatric Dentistry Clinics in King Abdulaziz University Dental Hospital (KAUDH),diagnosed to have at least two primary molars and/ or first permanent molars with early-stage caries (using bitewing radiographs, near infrared digital imaging transilluminaton (NIDIT), and visual assessment), and willing to return for follow up visits. If the child is eligible and the parents agree to the participation of their child in this study, the researcher will review the child's personal and medical history.
The child's two included molars diagnosed with early-stage caries will be randomly assigned to one of two groups: Control Group: will receive standard-of-care preventive measures. Test Group: will receive RMGI varnish application plus the standard-of-care preventive measures. The child will be followed up at six months and 12 months. A dental examination will be done using the same methods used in the first examination to determine whether the caries has become deeper or not. The child may be withdrawn from the study at this point if the caries has become too deep and the tooth will then need a filling.
The child's medical status will be up-dated, reinforcement of oral hygiene instruction and diet counseling will be provided, and fluoride varnish application will be applied to all the teeth in both six and 12 months follow-ups.The RMGI varnish will be reapplied to the test teeth at the six months follow up.
详细描述
Materials and Methods Sample:It will be 88 contralateral matched primary molars and/or first permanent molars with non-cavitated proximal carious lesion to be treated in children attending the Pediatric Dentistry Clinics at KAUDH, Jeddah, Saudi Arabia.The included lesions will be randomly allocated in a split-mouth design to be either in the test group or control group:The control group: will be treated with standard-of-care preventive measures which includes application of 5% sodium fluoride (NaF) topical varnish (Vanish 5% Sodium Fluoride White Varnish with Tri-Calcium Phosphate, 3M ESPE, Dental product 44-0007-4718-6-B, St. Paul, MN, 55144-1000 U.S.A. ), oral hygiene instruction, and dietary counseling.The test group: will be treated with light curable RMGI varnish (Vanish™ XT Extended Contact Varnish, 3M ESPE, Dental product 44-0007-4718-6-B, St. Paul, MN, 55144-1000 U.S.A.) in addition to standard-of-care preventive measures.
The Sample size:It was calculated based on the assumptions of odds of caries prevention for the light curable RMGI varnish and the fluoride varnish will be 5.6 and 1.9 respectively based on the literature. The estimated sample is a minimum of 80 pairs (160 lesions) of non-cavitated proximal carious lesions in primary molars and/or first permanent molars are required by the end of the study to detect a statistical difference between the groups at significance level of 0.05 with a power of 80% the sample size was calculated using GPower 3.1 software .To compensate for loss to follow up or other causes of attrition, an additional 10% will be added to the sample size, thus eight pairs will be added with a total of 88 pairs (176 lesions) needed at the start of the study.
Materials and Equipment:
For the lesion diagnosis: Bitewing radiographic examination will be performed using an XCP extension cone paralleling system with photo-stimulable phosphor (PSP) plate biteblocks. The NIDIT examination will be performed using the DIAGNOcam device (DIAGNOcam 2170, Sn 1001941; Kavo). Clinical examination will be performed using mouth mirrors, Community Periodontal Index probe, dental floss without wax, orthodontic elastic separators, a plier for teeth separation for the visual examination, and dental chair light.
Consent and ethical approval:Approval will be obtained from King Abdulaziz University, Research Ethics Committee of the Faculty of Dentistry. The nature of the study will be explained to the parents of the children who meet the inclusion criteria. An informed written consent form will be obtained from all the parents who agree to have their children participate in the study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Because of the nature of the study, the investigator who will apply the treatment will not be blind to the group allocation of the lesion. Yet, the investigators who will evaluate the radiographs, DIAGNOcam images, and perform the visual examination will be blinded to which group the lesion they are evaluating belongs. In addition, the statistician will be blinded.
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject's inclusion criteria:
- •The child has at least two matched bilateral primary molars and/or first permanent molars with proximal carious lesions in the same surfaces in enamel or outer dentin third as by bitewing radiographic examination and are non-cavitated by visual examination.
- •Their ages are five to eight years.
- •No known allergies to any of the components of the dental materials used in the study.
- •The parents are willing to commit to the follow-up visits.
- •Child is generally cooperative for dental treatment.
- •The tooth's inclusion criteria:
- •Primary molar and/or first permanent molars with a proximal carious lesion in enamel or outer dentin third assessed by bitewing radiographic examination and that is found to be non-cavitated after ICDAS visual examination.
- •Presence of a tooth adjacent to the lesion.
- •Normal tooth structure.
- •Absence of tooth mobility.
- •Tooth does not require restorative treatment.
排除标准
- •The subject's exclusion criteria:
- •Children with a medical history of a chronic disease.
- •Children who have abnormalities that affect tooth structure.
- •The need of sedation or general anesthesia for dental treatment.
- •The tooth exclusion criteria:
- •Primary molar and/or first permanent molars with a proximal carious lesion extending beyond the outer dentin third assessed by bitewing radiographic examination.
- •Primary molar and/or first permanent molars with a proximal carious lesion that is cavitated assessed by ICDAS visual examination.
- •Non-cavitated proximal carious lesion on the mesial of the first primary molars because the contact area with the primary canine is narrow and the possible presence of the primate space.
- •Distal surfaces of the first permanent molars because there is no contact with the second permanent molar (does not erupt in this age group).
研究组 & 干预措施
The control group
A total of 88 non-cavitated proximal carious lesions treated with standard-of-care preventive measures which include application of 5% sodium fluoride topical varnish (Vanish 5% Sodium Fluoride White Varnish with Tri-Calcium Phosphate, 3M ESPE, St. Paul, MN, U.S.A.), oral hygiene instruction, and dietary counseling applied at initial, six-months follow-up, and 12-months follow-up visits.
干预措施: standard-of-care preventive measures (Other)
The test group
Intervention: A total of 88 non-cavitated proximal carious lesions treated with light curable resin modified glass ionomer varnish (Vanish™ XT Extended Contact Varnish, 3M ESPE, St. Paul, MN, U.S.A.) at initial and six-months follow-up visits. In addition to, standard-of-care preventive measures, applied at initial, six-months follow-up, and 12-months follow-up visits.
干预措施: Light curable resin modified glass ionomer varnish (Device)
The test group
Intervention: A total of 88 non-cavitated proximal carious lesions treated with light curable resin modified glass ionomer varnish (Vanish™ XT Extended Contact Varnish, 3M ESPE, St. Paul, MN, U.S.A.) at initial and six-months follow-up visits. In addition to, standard-of-care preventive measures, applied at initial, six-months follow-up, and 12-months follow-up visits.
干预措施: standard-of-care preventive measures (Other)
结局指标
主要结局
Clinical progression of non-cavitated proximal carious lesions measured using ICDAS 12 months after treatment
时间窗: After 12 months.
To evaluate the clinical progression of non-cavitated proximal carious lesions in primary molars and first permanent molars measured using the ICDAS after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after 12 months.
Radiographic progression of non-cavitated proximal carious lesions assessed using bitewing radiographs six months after treatment
时间窗: After six months
To evaluate the radiographic progression of non-cavitated proximal carious lesions in primary molars and first permanent molars assessed by examination of bitewing radiographs after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after six months.
Radiographic progression of non-cavitated proximal carious lesions assessed using bitewing radiographs 12 months after treatment
时间窗: After 12 months
To evaluate the radiographic progression of non-cavitated proximal carious lesions in primary molars and first permanent molars assessed by examination of bitewing radiographs after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after 12 months.
Progression of non-cavitated proximal carious lesions measured with NILT six months after treatment
时间窗: After six months
To evaluate the progression of non-cavitated proximal carious lesions in primary molars and first permanent molars measured with NILT after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after six months.
Clinical progression of non-cavitated proximal carious lesions measured using ICDAS six months after treatment
时间窗: After six of treatment
To evaluate the clinical progression of non-cavitated proximal carious lesions in primary molars and first permanent molars measured using the ICDAS after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after six months.
Progression of non-cavitated proximal carious lesions measured with NILT 12 months after treatment
时间窗: After 12 months
To evaluate the progression of non-cavitated proximal carious lesions in primary molars and first permanent molars measured with NILT after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after 12 months.
次要结局
- The effect of plaque accumulation on the success rate of the treatment(After 12 months)
- The effect of gingival inflammation on the success rate of the treatment(After 12 months)
- he effect of the presence of adjacent restoration on the success rate of the treatment(After 12 months)
- The effect of caries severity on the success rate of the treatment(After 12 months)
研究者
Najlaa Alamoudi
Professor in Pediatric Dentistry Department, Medical Director, KAU-DH Program Director, Post Grad Studies for Master and PhD programs Program Director,of Saudi Commission for Health Specialities, Faculty of Dentistry- King Abdulaziz University
King Abdulaziz University