EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH (A RANDOMIZED CONTROLLED CLINICAL TRIAL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary outcome of this study will be to assess caries arrest status by assessing lesion severity and activity using (ICDAS-II) criteria and the change in mean DIAGNOdentTM readings at 1, 3 and 6 months follow up .
研究概览
简要总结
The goal of this randomized controlled clinical trial is to assess and compare the remineralizing effect of Biomin fluoride varnish and conventional 5% sodium fluoride varnish (Duraphat), with and without adjunctive low-level diode laser irradiation, in preschool children with active white spot lesions in primary anterior teeth. The study will include healthy children aged 3-6 years with at least one active, non-cavitated white spot lesion (ICDAS-II score 1 or 2). The study will be conducted at the Faculty of Dentistry, Alexandria University, with a total of 80 lesions randomly allocated to four parallel groups.
The main questions it aims to answer are:
Does Biomin fluoride varnish produce a different remineralizing effect compared with conventional 5% sodium fluoride varnish (Duraphat) after 6 months? Does adding 980-nm low-level diode laser irradiation to Biomin fluoride varnish or Duraphat improve the remineralization of white spot lesions compared with the corresponding varnish alone? Do the different treatments result in changes in lesion severity and activity, as assessed by ICDAS-II and DIAGNOdent readings? Do the treatments reduce the surface area of white spot lesions after 6 months?
Researchers will compare four treatment groups to assess differences in remineralization:
Group I (n=20): Biomin fluoride varnish (5% sodium fluoride incorporating bioactive glass).
Group II (n=20): Biomin fluoride varnish combined with low-level diode laser. Group III (n=20): Duraphat 5% sodium fluoride varnish combined with low-level diode laser.
Group IV (n=20): Duraphat 5% sodium fluoride varnish alone (control group).
Participants will:
Undergo baseline assessment of their white spot lesions using ICDAS-II visual-tactile examination, DIAGNOdent laser fluorescence, and standardized photographic assessment.
Receive the randomly assigned fluoride varnish treatment, with diode laser irradiation applied to Groups II and III using a 980-nm diode laser.
Return for follow-up assessments at 1, 3, and 6 months. At 3 months, the assigned varnish and laser treatment will be reapplied according to the group.
Have lesion severity and activity assessed using ICDAS-II and changes in mineralization assessed through DIAGNOdent readings. At 6 months, standardized photographs will also be used to evaluate changes in lesion surface area.
Follow post-treatment instructions, including avoiding fluoride-containing products on the day of varnish application and avoiding eating and drinking for at least 4 hours.
The primary outcome is caries arrest/remineralization assessed through changes in lesion severity and activity using ICDAS-II and changes in mean DIAGNOdent readings at 1, 3, and 6 months. The secondary outcome is the change in white spot lesion surface area measured by standardized photographic assessment at 6 months.
详细描述
White spot lesions (WSLs) are early manifestations of enamel caries characterized by subsurface mineral loss while the enamel surface remains clinically intact. In primary teeth, early lesions may progress rapidly, making non-invasive remineralization an important approach for preserving tooth structure and preventing progression to cavitation. Fluoride varnish is widely used for the management of early enamel lesions; however, conventional fluoride varnishes may have limited retention on the tooth surface and may primarily promote remineralization near the enamel surface.
Bioactive glass-containing materials have been developed as an alternative or adjunctive remineralization strategy. Biomin fluoride varnish incorporates bioactive glass capable of releasing calcium, phosphate, and fluoride ions in the oral environment. According to the protocol, the sustained release of these ions may promote formation of fluorapatite and potentially provide deeper and longer-lasting remineralization of early enamel lesions.
Low-level diode laser irradiation has also been proposed as an adjunct to topical fluoride treatment. The protocol describes laser irradiation as potentially increasing enamel resistance to acid attack and enhancing fluoride uptake. However, previous findings cited in the protocol are not consistent: some studies have suggested a synergistic effect between laser irradiation and remineralizing agents, whereas other studies have not demonstrated an additional benefit when laser treatment is combined with fluoride or Biomin products. The protocol therefore identifies a need for clinical evaluation of these approaches in primary teeth.
This study is designed as a four-arm, parallel, randomized controlled clinical trial. Participants meeting the study criteria will be randomly allocated to receive one of the study treatment approaches. The allocation will be computer-generated with an equal allocation ratio, and treatment assignment will be concealed until the intervention. The outcome assessor will remain blinded to treatment allocation.
The study will evaluate the clinical and quantitative changes occurring in active, non-cavitated white spot lesions during a 6-month follow-up period. Lesion status will be monitored using clinical assessment with the International Caries Detection and Assessment System (ICDAS-II) and quantitative assessment using laser-induced fluorescence with the DIAGNOdent™ pen. These assessments will allow changes in lesion severity, activity, and fluorescence readings to be followed over time. Standardized photographic records will additionally be used at the end of follow-up to evaluate changes in the proportional surface area of the lesions.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Healthy Children aged 3-6 years old.
- •Patients ranking definitely positive or positive on Frankel scale
- •The Presence of at least one active non-cavitated white spot lesion (ICDAS code 1 or 2) on the facial surface of primary teeth .
- •Completion of an informed consent by the guardian to participate in the study
排除标准
- •History of systemic disease or medication affecting enamel development
- •Teeth with cavitated lesions (ICDAS ≥ 3)
- •Previous professional fluoride treatment or laser therapy in the last 3 months
研究组 & 干预措施
Test group 1
• Group I (Test Group I): BioMin® fluoride varnish: 5% NaF varnish incorporating bioactive glass (calcium/phosphate releasing).
will be applied according to the manufacturer's instructions as follows
- Excess plaque should be removed
- Teeth should be isolated and gently dried
- BioMin fluoride varnish will be applied using a disposable microbrush in thin layer and allowed to set
干预措施: BioMin® fluoride varnish: 5% NaF varnish incorporating bioactive glass (calcium/phosphate releasing). (Other)
Test group 2
(BioMin® + Diode Laser): After application of BioMin® fluoride varnish as described above, the tooth surface will be irradiated using a diode laser with the following parameters:
- Wavelength: 980 nm.
- Operating Mode: Continuous wave.
- Fiber tip:320 µm.
- Radiant Energy :15 J.
- Mode: Non-contact mode.
- Duration: 30 seconds.
- Laser safety eyewear: OD ≥ 5 at 980 nm for operator, patient, and assistant.
干预措施: (BioMin® + Diode Laser) (Other)
Test group 3
(Duraphat varnish + Diode laser ): After application of DURAPHAT fluoride varnish as described above, the tooth surface will be irradiated using a diode laser with the following parameters:
- Wavelength: 980 nm.
- Operating Mode: Continuous wave.
- Fiber tip:320 µm.
- Mode: Non-contact mode.
- Duration: 30 seconds.
- Radiant Energy: 15 J.
- Laser safety eyewear: OD ≥ 5 at 980 nm for operator, patient, and assistant.
干预措施: (Duraphat varnish + Diode laser) (Other)
Control group
Duraphat varnish (5% sodium fluoride varnish) will be applied to all white spot lesions according to the manufacturers' instructions as follows:
- Excess plaque should be removed
- Teeth should be isolated and gently dried
- Duraphat can be applied using a brush in a thin layer on the affected areas and allowed to set.
干预措施: Duraphat varnish (5% sodium fluoride varnish) (Other)
结局指标
主要结局
The primary outcome of this study will be to assess caries arrest status by assessing lesion severity and activity using (ICDAS-II) criteria and the change in mean DIAGNOdentTM readings at 1, 3 and 6 months follow up .
时间窗: 6 months
The primary outcome of this study will be to assess caries arrest status by assessing lesion severity and activity using (ICDAS-II) criteria and the change in mean DIAGNOdentTM readings at 1, 3 and 6 months follow up .
次要结局
- • Assessment of the change in lesion surface area using standardized photographic assessment at 6 months follow up.(6 months)
研究者
Yassmin Mohamed
Pediatric Dentistry Resident at Faculty of Dentistry Alexandria University
Alexandria University