Effect of S-PRG Filler in Prevention White Spot Lesions During Orthodontic Treatment: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Occurrence of White Spot Lesions During Orthodontic Treatment
研究概览
简要总结
White spot lesions are early areas of enamel demineralization that may develop during orthodontic treatment with fixed braces. This study aims to evaluate the effectiveness of S-PRG Barrier Coat in preventing white spot lesions during orthodontic treatment. The study will compare S-PRG Barrier Coat with 5% sodium fluoride varnish, a combination of S-PRG Barrier Coat and 5% sodium fluoride varnish, and a placebo. A total of 144 participants undergoing orthodontic treatment will be randomly assigned to one of four treatment groups. The occurrence and severity of white spot lesions will be assessed using clinical examinations, including the ICDAS-II and Gorelick index, together with DIAGNOdent readings where applicable. The study findings may help determine whether S-PRG Barrier Coat provides an effective preventive approach against orthodontic white spot lesions.
详细描述
White spot lesions (WSLs) are early manifestations of enamel demineralization that may occur during orthodontic treatment with fixed appliances. Brackets and archwires can increase plaque accumulation and make oral hygiene more difficult, potentially increasing the risk of enamel demineralization. Although fluoride-based preventive measures are commonly used, additional preventive approaches may be beneficial.
S-PRG (Surface Pre-Reacted Glass-ionomer) bioactive fillers have the potential to release various ions, including fluoride and strontium, which may contribute to the inhibition of demineralization and promotion of remineralization. S-PRG Barrier Coat is therefore being investigated as a potential preventive material for orthodontic WSLs.
Study Objective
The objective of this study is to evaluate the effect of S-PRG Barrier Coat in preventing white spot lesions during orthodontic treatment. Its preventive effect will be compared with 5% sodium fluoride varnish, a combination of S-PRG Barrier Coat and 5% sodium fluoride varnish, and a placebo.
Study Design
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled to undergo fixed orthodontic treatment at the Faculty of Dentistry, Universiti Kebangsaan Malaysia (UKM), who provide informed consent. For participants below 18 years of age, parental or guardian consent will be obtained.
- •Patients receiving orthodontic brackets on at least the upper incisors and canines, with an anticipated treatment duration of at least 12 months.
- •Patients with any degree of malocclusion.
- •Patients without pre-existing white spot lesions on the teeth being assessed.
- •Medically fit and healthy patients.
- •Non-smokers.
- •Patients who can understand and communicate in basic English or Bahasa Malaysia
排除标准
- •Previous history of fixed orthodontic treatment.
- •Presence of dental anomalies or developmental defects of enamel (DDE) on the labial surfaces of the teeth, including pre-existing fluorosis or enamel hypoplasia.
- •Presence of direct or indirect restorations on the labial surfaces of the teeth being assessed.
- •History of long-term antibiotic use.
- •Presence of untreated cavitated carious lesions, particularly involving the upper or lower incisors and canines.
- •Plaque level greater than 30%.
- •Known allergy to any component of the intervention materials, including sodium fluoride or glass ionomer.
研究组 & 干预措施
5% Sodium Fluoride Varnish
Participants receive 5% sodium fluoride varnish as the active comparator during orthodontic treatment with fixed appliances.
干预措施: 5% sodium fluoride varnish (Other)
S-PRG + 5% Sodium Fluoride Varnish
Participants receive the combined S-PRG Barrier Coat and 5% sodium fluoride varnish intervention during orthodontic treatment with fixed appliances.
干预措施: S-PRG Barrier Coat + 5% Sodium Fluoride Varnish (Combination Product)
Placebo-Normal Saline
Participants receive a placebo (normal saline) during orthodontic treatment with fixed appliances.
干预措施: Placebo - Normal Saline (Other)
S-PRG Barrier Coat
Participants receive S-PRG Barrier Coat as the assigned preventive intervention during orthodontic treatment
干预措施: S-PRG Barrier Coat (Other)
结局指标
主要结局
Occurrence of White Spot Lesions During Orthodontic Treatment
时间窗: 12 months after initiation of orthodontic treatment
The occurrence of white spot lesions will be assessed clinically using the International Caries Detection and Assessment System (ICDAS-II) and the Gorelick index. The presence or absence of white spot lesions will be compared among the four treatment groups.
次要结局
- Comparative Effectiveness of S-PRG Filler and 5% Sodium Fluoride Varnish in Preventing White Spot Lesions Assessed by ICDAS-II(12 months after initiation of fixed orthodontic treatment.)
研究者
Dr. Noor Sam bin Ahmad
DR
National University of Malaysia