Periodontal Status in Patients With Chronic Skin Diseases

Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City (Other)
Overall Status
Completed
CT.gov ID
NCT06073613
Collaborator
(none)
146
1
3.2
45.3

Study Details

Study Description

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 0.05.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: oral health status

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 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).

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 Jeffrey's Amazing Statistics Program (JASP) software, version 0.17.2.1 (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 <0.05 was considered statistically significant.

Study Design

Study Type:
Observational
Actual Enrollment :
146 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Periodontal Status in Patients With Chronic Skin Diseases: a Pilot Study
Actual Study Start Date :
Jan 20, 2023
Actual Primary Completion Date :
Feb 28, 2023
Actual Study Completion Date :
Apr 28, 2023

Arms and Interventions

Arm Intervention/Treatment
control group

healthy individuals, aged 18 years or older and free of chronic skin diseases, willing to participate in the study

Diagnostic Test: oral health status
CSDs medical records: Information related to epidemiological characteristics and chronic inflammatory skin conditions (psoriasis, atopic dermatitis, autoimmune bullous diseases, or systemic lupus erythematosus,…) were recorded from medical records: Pemphigus Mixed connective tissue disease Atopic dermatitis Psoriasis Erythroderma oral health status: oral clinical parameters were evaluated: Full mouth bleeding on probing scores Pocket probing depth Clinical attachment level debris index calculus index the number of oral lesions
Other Names:
  • CSDs medical records
  • Patients with CSDs

    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

    Diagnostic Test: oral health status
    CSDs medical records: Information related to epidemiological characteristics and chronic inflammatory skin conditions (psoriasis, atopic dermatitis, autoimmune bullous diseases, or systemic lupus erythematosus,…) were recorded from medical records: Pemphigus Mixed connective tissue disease Atopic dermatitis Psoriasis Erythroderma oral health status: oral clinical parameters were evaluated: Full mouth bleeding on probing scores Pocket probing depth Clinical attachment level debris index calculus index the number of oral lesions
    Other Names:
  • CSDs medical records
  • Outcome Measures

    Primary Outcome Measures

    1. Full mouth bleeding on probing scores (BOP) [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

    2. Pocket probing depth (PPD) [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

    3. Clinical attachment level (CAL) [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

    4. debris index (DI) [Baseline]

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

    5. calculus index (CI) [Baseline]

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

    6. the number of oral lesions [Baseline]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • Toothless

    • Limited mouth opening

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Medicine and Pharmacy at Ho Chi Minh city Ho Chi Minh City Vietnam 70000

    Sponsors and Collaborators

    • University of Medicine and Pharmacy at Ho Chi Minh City

    Investigators

    • Study Director: Hao Trong Nguyen, PhD, Ho Chi Minh City Hospital of Dermato-Venereology, Ho Chi Minh City, Vietnam
    • Study Director: Thuy Thu Nguyen, PhD, University of Medicine and Pharmacy at Ho Chi Minh City

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hoa Ho Thi, Inverstigator, University of Medicine and Pharmacy at Ho Chi Minh City
    ClinicalTrials.gov Identifier:
    NCT06073613
    Other Study ID Numbers:
    • HoChiMinhCityUMP_FOS
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 10, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hoa Ho Thi, Inverstigator, University of Medicine and Pharmacy at Ho Chi Minh City
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 10, 2023