Effectiveness of Nano Silver Fluoride and Photobiomodualtion Therapy on Hypersensitivity and Pain During Cavity Preparation and The Restoration Outcomes in Molars Affected by Molar Incisor Hypomineralization: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Pain During Cavity Preparation and Restoration
研究概览
简要总结
Molar-incisor hypomineralization (MIH) is a developmental condition affecting primarily the first permanent molars and may be associated with post-eruptive enamel breakdown, hypersensitivity, and difficulties in achieving adequate pain control during dental treatment.
This randomized controlled trial will evaluate the effectiveness of nano silver fluoride (NSF) and photobiomodulation therapy (PBMT) as desensitizing interventions applied before cavity preparation in children aged 7-12 years with MIH-affected first permanent molars with post-eruptive enamel breakdown. The study will compare the effects of NSF and PBMT with a control group receiving pre-appointment analgesics.
Hypersensitivity will be assessed using the Cumulative Hypersensitivity Index (CHI), while pain during cavity preparation and restoration will be evaluated using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring. All treated molars will receive glass ionomer cement restorations, which will subsequently be evaluated using the Modified United States Public Health Service (USPHS) criteria at 3, 6, and 12 months.
详细描述
Molar-incisor hypomineralization (MIH) is a developmental condition primarily affecting the enamel of the first permanent molars. Affected teeth may exhibit demarcated opacities, post-eruptive structural loss of enamel, hypersensitivity, and difficulties during restorative treatment.
This study will evaluate the effect of using nano silver fluoride (NSF) and photobiomodulation therapy (PBMT) as desensitizing agents prior to cavity preparation in permanent molars affected by MIH with post-eruptive enamel breakdown.
A total of 45 children aged 7-12 years will be included and randomly assigned to three groups, with 15 participants in each group:
Group A: Nano silver fluoride (NSF). The affected molar will receive a single application of NSF 15 days before cavity preparation and restoration.
Group B: Photobiomodulation therapy (PBMT). The affected molar will receive PBMT 15 days before cavity preparation and restoration using a low-level diode laser with a wavelength of 980 nm and a power output of 100 mW.
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)
盲法说明
Statistician
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 7-12 years diagnosed with molar-incisor hypomineralization (MIH) in first permanent molars according to the European Academy of Paediatric Dentistry (EAPD) criteria.
- •MIH-affected teeth exhibiting demarcated opacity, post-eruptive structural loss of enamel, and hypersensitivity (Treatment Need Index = 4).
- •Children who are able to cooperate during treatment and attend scheduled follow-up visits.
- •Children whose parents or legal guardians provide informed consent for participation in the study.
排除标准
- •Hypomineralized molars caused by other conditions, including syndromes, fluorosis, enamel hypoplasia, amelogenesis imperfecta, or dental caries.
- •Teeth with defective restorations or pulpal symptoms.
- •History of desensitizing treatment within the previous 6 months.
- •Use of anti-inflammatory drugs or analgesics at the time of recruitment.
- •Children who are physically or mentally disabled or who have a medical condition that may complicate treatment.
- •Reported allergy to silver or any material included in the study.
研究组 & 干预措施
Photobiomodulation Therapy
Participants assigned to this group will receive photobiomodulation therapy (PBMT) 15 days before cavity preparation and restoration.
A low-level diode laser with a wavelength of 980 nm and a power output of 100 mW will be used. The laser tip will be positioned perpendicular to three points: mesial and distal to the cervical region and the central part of the tooth lesion or opacity. Each irradiation point will receive laser exposure for 20 seconds, delivering a total energy dose of 2 J. Standard laser safety measures, including protective eyewear for the patient and operator, will be implemented.
Hypersensitivity will be assessed at baseline, 15 minutes after laser application, and again after 15 days before cavity preparation and restoration.
干预措施: Photobiomodulation Therapy (Other)
Control
Participants assigned to the control group will receive oral hygiene instructions and a prescription for pre-appointment analgesics before cavity preparation and restoration. Hypersensitivity will be assessed at baseline. At the second visit, hypersensitivity will be reassessed, followed by conventional cavity preparation and restoration. Pain during the procedure will be evaluated using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring.
干预措施: Pre-appointment analgesics (Drug)
Nano Silver Fluoride
Participants assigned to this group will receive a single application of nano silver fluoride (NSF) to the affected first permanent molar 15 days before cavity preparation and restoration.
The tooth will be isolated using cotton rolls and suction, and plaque or gross debris will be removed. A single drop of NSF solution will be dispensed into a plastic dappen dish and applied to the entire lesion using a disposable microbrush. Excess solution will be removed with a cotton swab. The solution will remain in contact with the tooth surface for 1 minute. Hypersensitivity will be assessed at baseline and 15 minutes after application, and again after 15 days before cavity preparation and restoration.
干预措施: Nano Silver Fluoride (Other)
结局指标
主要结局
Pain During Cavity Preparation and Restoration
时间窗: During the cavity preparation and restoration procedure at the second visit, 15 days after application of the assigned desensitizing intervention.
Pain during cavity preparation and restoration will be assessed using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring.
次要结局
- Hypersensitivity(Baseline, 15 minutes after intervention, and 15 days after intervention.)