Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06073613
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2023-09-26
Brief Title:
Periodontal Status in Patients With Chronic Skin Diseases
Sponsor:
University of Medicine and Pharmacy at Ho Chi Minh City
Organization:
University of Medicine and Pharmacy at Ho Chi Minh City
Study Overview
Official Title:
Periodontal Status in Patients With Chronic Skin Diseases a Pilot Study
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 005
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 005
Detailed Description:
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 08
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
The investigator examined one tooth index teeth from each sextant including the incisor left and right molar regions for both the maxillary and mandibular dental arches to record the CAL DI and CI
Statistics analysis All statistical analysis was performed using Jeffreys Amazing Statistics Program JASP software version 01721 University of Amsterdam Amsterdam The Netherlands The normality of distribution of the data was verified using the Shapiro-Wilk test For variables that were under normal distribution independent t-test test was used for detecting the statistically significant differences among two groups For variables that were not normally distributed Mann-Whitney test was used to compare among two groups P value of 005 was considered statistically significant
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 08
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
The investigator examined one tooth index teeth from each sextant including the incisor left and right molar regions for both the maxillary and mandibular dental arches to record the CAL DI and CI
Statistics analysis All statistical analysis was performed using Jeffreys Amazing Statistics Program JASP software version 01721 University of Amsterdam Amsterdam The Netherlands The normality of distribution of the data was verified using the Shapiro-Wilk test For variables that were under normal distribution independent t-test test was used for detecting the statistically significant differences among two groups For variables that were not normally distributed Mann-Whitney test was used to compare among two groups P value of 005 was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None