Comparative Remineralizing Efficacy of Giomer Bioactive Barrier Varnish vs. Fluoride Varnish in Management of White Spot Lesions in Adult Patients: Randomized Controlled Tria
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 26
- 主要终点
- Change in Remineralization efficacy.
研究概览
简要总结
To evaluate the remineralizing capability of biosmart S-PRG barrier coat varnish and its employment in clinical practice
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)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Age range between 18 and 40 years.
- •Patients with no systemic diseases, syndromic abnormalities, or proven/suspected milk protein allergy and/or sensitivity
- •Patients with fair oral hygiene (mild to moderate plaque accumulation).
- •Patients with non-cavitated initial carious lesions grade 0 or 1 caries in accordance with The Nyvad caries diagnostic criteria.
- •The patient did not receive any remineralizing agent other than the regular toothpaste during the past three months.
排除标准
- •• Severe or active periodontal disease.
- •Patients had received therapeutic irradiation to the head and neck region.
- •Patients had participated in a clinical trial within 6 months before commencement of this trial.
- •Patients unable to return for recall appointments
- •Presence of abnormal oral, medical, or mental condition.
- •Presence of dentin caries or enamel hypoplasia on maxillary anterior teeth.
- •Patients with glass ionomer restorations because the glass ionomer restoration release fluoride in the oral cavity, potentially impacting the results.
研究组 & 干预措施
Bio-smart Light Cured Protective Shield with bioactive S-PRG filler technology (PRG Barrier Coat)
Surface reaction-type pre-released glass ionomer (S-PRG) fillers containing dental materials are now commercially available. It was shown that PRG filler is an active ingredient with the ability to release and recharge fluoride ions. In addition, S-PRG fillers release five other active ions, Sr2þ, SiO3 2, Naþ, BO3 3, and Al3þ. S-PRG filler has a modulation effect on acidic conditions, causing the surrounding environment to become weakly alkaline upon contact with water or acidic solutions. This effect was thought to be brought by Sr, B, Na, and F ions released from S-PRG filler. A fluoride-releasing coating material containing S-PRG filler (PRG BarrierCoat®, SHOFU, Japan) was manufactured as a coating material to suppress dentin hypersensitivity and prevent caries on smooth surface areas
干预措施: Bio-smart Light Cured Protective Shield with bioactive S-PRG (Surface Pre- Reacted Glass ionomer) filler technology (PRG Barrier Coat) by (By SHOFU Inc., Japan). (Drug)
5% NaF varnish (Proflourid Varnish VOCO America Inc.).
The gold standard remineralizing agent recommended by the guidelines
干预措施: Bio-smart Light Cured Protective Shield with bioactive S-PRG (Surface Pre- Reacted Glass ionomer) filler technology (PRG Barrier Coat) by (By SHOFU Inc., Japan). (Drug)
结局指标
主要结局
Change in Remineralization efficacy.
时间窗: Baseline, 1 month, 3 months
Determination of lesion level by DIAGNOdent which provides a laser fluorescence feedback to give a numerical readout reflecting the amount of demineralization
次要结局
- Change in Caries lesion activity assessment(Baseline, 1 month, 3 months)
研究者
Hisham Amr Mohamed Kotb
Master degree student, Conservative Dentistry Department Principal investigator
Cairo University