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临床试验/NCT06330272
NCT06330272进行中(未招募)不适用

Accuracy of Spectrophotometry in Determining the Mineralization of Molar-incisor Hypomineralization Lesions by CPP-ACPF Dental Mousse: Clinical Study

Meire Coelho Ferreira2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2025年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
98
试验地点
2
主要终点
To measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse

研究概览

简要总结

MIH is a condition with considerable prevalence in the child population. This structural defect, represented by a change in the color of the enamel, can be accompanied by structural loss and great sensitivity. Remineralizing agents have been used to strengthen compromised enamel. The objective of the study will be to measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse.

详细描述

Molar-incisor hypomineralization (MIH) is a qualitative structural defect of tooth enamel characterized by a marked opacity, asymmetrically involving the first permanent molars and incisors. Some products containing casein phosphopeptide-amorphous calcium phosphate fluoride (CPP-ACPF) have been used in children with MIH. Casein, a protein derived from milk, promotes a remineralizing effect through enzymes present in the oral cavity. The objective of the study will be to evaluate the accuracy of a spectrophotometer (VITA Easyshade V) in the indirect determination of the mineralization of IMH lesions by a dental foam based on CPP-ACPF (Tooth Mousse Plus™). Upper or lower permanent incisors of children aged 7 to 9 years will be included in the study. Two duly calibrated operators will select participants at the Ceuma University Pediatric Dentistry Clinic and the diagnosis of MIH lesions will be carried out using the European Association of Pediatric Dentistry (EAPD) criteria. Inclusion criteria will be permanent incisors with mild MIH lesions (marked opacities without structural loss) of at least 2mm in diameter, white or beige/yellowish in color and that do not present visible bacterial biofilm. Children with enamel malformation associated with syndromes, amelogenesis imperfecta, fluorosis and dental erosion will be excluded; and children allergic to milk proteins (casein). A questionnaire to collect demographic, socioeconomic information and etiological factors for MIH will be administered to parents/guardians. The color of the lesion will be measured before applying the dental foam at baseline and at other follow-up times. It will be measured using the VITA Easyshade V spectrophotometer (Vita Zahnfakrik, Bad Säckingen, Germany). This measurement will be represented by the luminosity parameter (L) and will occur three times on the same tooth to obtain the average values. The change in color (ΔL) of the lesion will be determined from the initial data minus the data after 1 month of evaluation (before the application of dental foam). The visual appearance of the lesion (opaque or shiny appearance) will be assessed initially (opaque lesion for inclusion of the tooth in the research) and further follow-up times (before applying the foam). The lesion will also be assessed tactilely (presence or absence of roughness) prior to the initial treatment and further follow-up times (before applying the foam). The presence of sensitivity will be assessed initially and during follow-up times (before applying the foam) using an air jet. Demographic, socioeconomic and data related to probable etiological factors for MIH will also be collected. The data will be subjected to descriptive and inferential analysis (tests for dependent measures and agreement analysis).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Permanent incisors with mild MIH lesions (marked opacities without structural loss) of at least 2mm in diameter;
  • White or beige/yellowish MIH lesions;
  • Not present visible bacterial biofilm.

排除标准

  • Children with enamel malformation associated with syndromes, amelogenesis imperfecta, fluorosis and dental erosion;
  • Children allergic to milk proteins (casein).

结局指标

主要结局

To measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse

时间窗: 1 month

The spectrophotometry analysis was determined by the Kappa statistic (95% confidence interval) (primary outcome of the study).

次要结局

未报告次要终点

研究者

发起方
Meire Coelho Ferreira
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Meire Coelho Ferreira

Principal Investigator

Universidade Ceuma

研究点 (2)

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