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临床试验/NCT06073613
NCT06073613已完成不适用

Periodontal Status in Patients With Chronic Skin Diseases: a Pilot Study

University of Medicine and Pharmacy at Ho Chi Minh City1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2023年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
146
试验地点
1
主要终点
Full mouth bleeding on probing scores (BOP)

研究概览

简要总结

Objective: This study aimed to evaluate and compare the periodontal status of chronic skin disease (CSD) patients with healthy controls.

Material and method: 109 patients and 37 healthy subjects were included in this study. Parameters evaluated included bleeding on probing index (BOP), periodontal pocket depths (PPD), clinical attachment level (CAL), simplified debris index (DI), simplified calculus index (CI), and the presence of oral lesions. Clinical parameters were measured and compared in the two groups. The significant level was set at 0.05.

详细描述

Patients with CSDs (psoriasis, atopic dermatitis, autoimmune bullous diseases, or systemic lupus erythematosus,...) were diagnosed by the dermatologists with over 5 years of experience and supportive laboratory tests, aged 18 years or older, and willing to participate in the study. The control group included healthy individuals, aged 18 years or older and free of chronic skin diseases. These individuals were willing to participate in the study and would be used as a comparison group for the case group.

Clinical parameter collection Information related to epidemiological characteristics and chronic inflammatory skin conditions were recorded from medical records and oral health status was collected from clinical examination conducted by postgraduate doctors and lecturers of the Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City. The investigators were trained by a specialist in public dentistry and had intra-rater and inter-rater reliability of more than or equal to 0.8.

The following oral clinical parameters were evaluated:

  1. Full mouth bleeding on probing scores (BOP): BOP was recorded and considered positive when bleeding occurred within 20 seconds after the probe was removed after application with light pressure. A bleeding percentage was calculated for each patient by dividing the total number of positive bleeding sites by the total number of probed sites.
  2. Pocket probing depth (PPD) was measured from the gingival margin to the base of the gingival sulcus/ periodontal pocket with the aid of a University of North Carolina (UNC) 15-mm periodontal probe.
  3. Clinical attachment level (CAL) was measured from the cemento-enamel junction (CEJ) to the base of the gingival sulcus/ periodontal pocket with the aid of a UNC periodontal probe. The CAL was considered zero if the attachment was at the level of the CEJ. If the free gingival margin was coronal to the CEJ, the CAL was determined by measuring the PPD and subtracting the distance from the CEJ to the free gingival margin. When the free gingival margin was apical to the CEJ, the CAL was determined by measuring the distance from the CEJ to the free gingival margin and adding it to the PPD.
  4. debris index (DI), and (5) calculus index (CI), which were evaluated pertaining to the Simplified Oral Hygiene Index (OHI-S) as suggested by Green and Vermillion (1964)

(6) the number of oral lesions. Probed sites were classified into three different categories of PPD and CAL (≤ 3 mm, 4-5 mm, > 6mm).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Patient CSDs:
  • were diagnosed in CSDs (psoriasis, atopic dermatitis, autoimmune bullous diseases, or systemic lupus erythematosus...) by the dermatologists with over 5 years of experience and supportive laboratory tests
  • aged 18 years or older
  • willing to participate in the study
  • Control group:
  • aged 18 years or older
  • free of chronic skin diseases

排除标准

  • Toothless
  • Limited mouth opening

结局指标

主要结局

Full mouth bleeding on probing scores (BOP)

时间窗: baseline

BOP was recorded and considered positive when bleeding occurred within 20 seconds after the probe was removed after application with light pressure. A bleeding percentage was calculated for each patient by dividing the total number of positive bleeding sites by the total number of probed sites

Pocket probing depth (PPD)

时间窗: baseline

PPD was measured from the gingival margin to the base of the gingival sulcus/ periodontal pocket with the aid of a University of North Carolina (UNC) 15-mm periodontal probe

the number of oral lesions

时间窗: Baseline

Probed sites were classified into three different categories of PPD and CAL (≤ 3 mm, 4-5 mm, \> 6mm)

debris index (DI)

时间窗: Baseline

DI were evaluated pertaining to the Simplified Oral Hygiene Index (OHI-S) as suggested by Green and Vermillion (1964)

Clinical attachment level (CAL)

时间窗: Baseline

was measured from the cemento-enamel junction (CEJ) to the base of the gingival sulcus/ periodontal pocket with the aid of a UNC periodontal probe. The CAL was considered zero if the attachment was at the level of the CEJ. If the free gingival margin was coronal to the CEJ, the CAL was determined by measuring the PPD and subtracting the distance from the CEJ to the free gingival margin. When the free gingival margin was apical to the CEJ, the CAL was determined by measuring the distance from the CEJ to the free gingival margin and adding it to the PPD

calculus index (CI)

时间窗: Baseline

CI were evaluated pertaining to the Simplified Oral Hygiene Index (OHI-S) as suggested by Green and Vermillion (1964)

次要结局

未报告次要终点

研究者

发起方
University of Medicine and Pharmacy at Ho Chi Minh City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hoa Ho Thi

Inverstigator

University of Medicine and Pharmacy at Ho Chi Minh City

研究点 (1)

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