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临床试验/NCT06291129
NCT06291129进行中(未招募)不适用

Assessment of Oral Hygiene, Gingival Health, and Malocclusion Among Type 1 Diabetic Children and Adolescents: an Original Article

Universidade Federal Fluminense2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
36
试验地点
2
主要终点
Bleeding on probing

研究概览

简要总结

Introduction: This study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes. Methods: The sample consisted of 36 children, who were distributed into two groups: DM; n=18 and NDM; n=18. Periodontal parameters considered were plaque Index (PI), gingival Index (GI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL). Gingival biotype clinical parameters: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars. Malocclusion were evaluated by the Dental Aesthetic Index (DAI) and the Angle's Classification. The statistical analyses were Shapiro Wilk test and T test.

详细描述

Introduction

This study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes. Methods: The sample consisted of 36 children (age 8 to 18 years old), who were distributed into two groups: patients with type 1 diabetes (DM; n=18) and control patients without diabetes (NDM; n=18). Periodontal parameters considered were plaque Index (PI), gingival Index (GI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL). Gingival biotype clinical parameters were evaluated by three aspects: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars. Malocclusion, its prevalence, severity and need of treatment were evaluated by the Dental Aesthetic Index (DAI) and the Angle's Classification. The statistical analyses were Shapiro Wilk test and T test.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • child or adolescent with the age between 8 and 18 years old

排除标准

  • child or adolescent who had an active or inactive caries lesion, on the buccal surface, in the cervical region of the elements to be analyzed;
  • participants with probing depth greater than or equal to 4 mm, which is characterized as periodontitis;
  • the patient who is undergoing orthodontic treatment, with fixed appliance;
  • pregnant women, nursing mothers.

研究组 & 干预措施

Hematological and Periodontal Parameters

Other

Hematological parameters were recorded - fasting blood glucose and glycosylated hemoglobin - to confirm the allocation of each participant between the groups: diabetic (DM) and control (NDM). The clinical periodontal parameters, including plaque index (PI) and bleeding on probing (GI) full mouth (Ainamo & Bay 1975), and plaque index (PI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL). Gingival biotype clinical parameters were evaluated by three aspects: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars. For the periodontal parameters' examination, a periodontal probe PCP15 (PCP-UNC15, Hu-Friedy, Chicago, IL) was used, excluding third molars and erupting teeth. The intraexaminer agreement of the categorical variables (CAL) using the kappa calculation was 7.64, at the tooth level.

干预措施: Periodontal therapy (Procedure)

Orthodontic Parameters

No Intervention

The clinical orthodontic parameters were recorded by the Angle's Classification, witch evaluated occlusion of right and left canines and molars, and the Dental Aesthetic Index (DAI) that evaluates the prevalence of malocclusions, its severity and the need for treatment. DAI aspects evaluated were: upper teeth loss, lower teeth loss, crowding, spacing, diastema, maxillary misalignment, mandibular misalignment, anterior maxillary overjet, anterior mandibular overjet, anterior open bite, molar relationship.

结局指标

主要结局

Bleeding on probing

时间窗: Twenty-one days

Bleeding levels on probing below 10% of the periodontal sites evaluated.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriela Alessandra da Cruz Galhardo Camargo

PhD

Universidade Federal Fluminense

研究点 (2)

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