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CompletedNCT06073613Updated Oct 10, 2023

Periodontal Status in Patients With Chronic Skin Diseases

An observational study in Periodontal Diseases, Psoriasis and Atopic Dermatitis, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Completed at 1 site in Vietnam. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
146
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Periodontal Diseases
  • Psoriasis
  • Atopic Dermatitis
  • Autoimmune Bullous Dermatosis
  • Systemic Lupus Erythematosus

Keywords

  • chronic skin disease
  • periodontal status
  • oral lesions
03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's enrollment of 146 is above the median of 100 across 291 observational studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 118 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

A prospective case-control study was conducted at Ho Chi Minh City Hospital of Dermato-Venereology in February 2023 to assess the periodontal status of patients with CSDs. The study included 109 patients with CSDs, including psoriasis, atopic dermatitis, lupus, and common autoimmune bullous skin diseases, and 37 healthy controls.

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

Exclusion Criteria:

  • Toothless
  • Limited mouth opening
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
146 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • Diagnostic testoral 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

    Also known as: CSDs medical records

06

What researchers measure

Primary outcomes

  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

    Time frame: baseline

  2. Pocket probing depth (PPD)

    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

    Time frame: baseline

  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

    Time frame: Baseline

  4. debris index (DI)

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

    Time frame: Baseline

  5. calculus index (CI)

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

    Time frame: Baseline

  6. the number of oral lesions

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

    Time frame: Baseline

07

Study locations

1 site
  • University of Medicine and Pharmacy at Ho Chi Minh city
    Ho Chi Minh City, 70000, Vietnam
08

References and documents

Publications

  • Arduino PG, Farci V, D'Aiuto F, Carcieri P, Carbone M, Tanteri C, Gardino N, Gandolfo S, Carrozzo M, Broccoletti R. Periodontal status in oral mucous membrane pemphigoid: initial results of a case-control study. Oral Dis. 2011 Jan;17(1):90-4. doi: 10.1111/j.1601-0825.2010.01709.x. PubMed 20659265 ↗
  • Lo Russo L, Gallo C, Pellegrino G, Lo Muzio L, Pizzo G, Campisi G, Di Fede O. Periodontal clinical and microbiological data in desquamative gingivitis patients. Clin Oral Investig. 2014 Apr;18(3):917-25. doi: 10.1007/s00784-013-1038-8. Epub 2013 Jul 31. PubMed 23900791 ↗
  • Lo Russo L, Guiglia R, Pizzo G, Fierro G, Ciavarella D, Lo Muzio L, Campisi G. Effect of desquamative gingivitis on periodontal status: a pilot study. Oral Dis. 2010 Jan;16(1):102-7. doi: 10.1111/j.1601-0825.2009.01617.x. Epub 2009 Sep 4. PubMed 19735453 ↗
  • Ramon-Fluixa C, Bagan-Sebastian J, Milian-Masanet M, Scully C. Periodontal status in patients with oral lichen planus: a study of 90 cases. Oral Dis. 1999 Oct;5(4):303-6. doi: 10.1111/j.1601-0825.1999.tb00094.x. PubMed 10561718 ↗
  • Schellinck AE, Rees TD, Plemons JM, Kessler HP, Rivera-Hidalgo F, Solomon ES. A comparison of the periodontal status in patients with mucous membrane pemphigoid: a 5-year follow-up. J Periodontol. 2009 Nov;80(11):1765-73. doi: 10.1902/jop.2009.090244. PubMed 19905946 ↗
  • Thorat MS, Raju A, Pradeep AR. Pemphigus vulgaris: effects on periodontal health. J Oral Sci. 2010 Sep;52(3):449-54. doi: 10.2334/josnusd.52.449. PubMed 20881339 ↗
  • Tricamo MB, Rees TD, Hallmon WW, Wright JM, Cueva MA, Plemons JM. Periodontal status in patients with gingival mucous membrane pemphigoid. J Periodontol. 2006 Mar;77(3):398-405. doi: 10.1902/jop.2006.050113. PubMed 16512754 ↗
  • Jascholt I, Lai O, Zillikens D, Kasperkiewicz M. Periodontitis in oral pemphigus and pemphigoid: A systematic review of published studies. J Am Acad Dermatol. 2017 May;76(5):975-978.e3. doi: 10.1016/j.jaad.2016.10.028. Epub 2016 Dec 28. PubMed 28038889 ↗
  • Macklis P, Adams K, Kaffenberger J, Kumar P, Krispinsky A, Kaffenberger B. The Association Between Oral Health and Skin Disease. J Clin Aesthet Dermatol. 2020 Jun;13(6):48-53. Epub 2020 Jun 1. PubMed 32884621 ↗
  • Rai NP, Kumar P, Mustafa SM, Divakar DD, Kheraif AA, Ramakrishnaiah R, Vellapally S, Dalati MH, Parine NR, Anil S. Relation Between Periodontal Status and Pre-Cancerous Condition (Oral Lichen Planus): A Pilot Study. Adv Clin Exp Med. 2016 Jul-Aug;25(4):763-6. doi: 10.17219/acem/59014. PubMed 27629852 ↗
  • Listgarten MA. Pathogenesis of periodontitis. J Clin Periodontol. 1986 May;13(5):418-30. doi: 10.1111/j.1600-051x.1986.tb01485.x. PubMed 3522650 ↗
  • Offenbacher S, Heasman PA, Collins JG. Modulation of Host PGE2 Secretion as a Determinant of Periodontal Disease Expression. J Periodontol. 1993 May;64 Suppl 5S:432-444. doi: 10.1902/jop.1993.64.5s.432. PubMed 29539680 ↗
  • GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available. PubMed 14076341 ↗
  • Akman A, Kacaroglu H, Yilmaz E, Alpsoy E. Periodontal status in patients with pemphigus vulgaris. Oral Dis. 2008 Oct;14(7):640-3. doi: 10.1111/j.1601-0825.2008.01445.x. PubMed 18627505 ↗

Individual participant data

Plan to share: Undecided — Study conception and design by groups of 8 researchers working at Ho Chi Minh City Hospital of Dermato-Venereology, Ho Chi Minh City, Vietnam and Faculty of Odonto-stomatology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06073613
Lead sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Responsible party
Hoa Ho Thi (Inverstigator, University of Medicine and Pharmacy at Ho Chi Minh City) — Principal investigator
First posted
Oct 10, 2023
Start date
Jan 20, 2023
Primary completion
Feb 28, 2023
Completion
Apr 28, 2023
Last update
Oct 10, 2023

Study contacts

Hao Trong Nguyen, PhD
study director · Ho Chi Minh City Hospital of Dermato-Venereology, Ho Chi Minh City, Vietnam
Thuy Thu Nguyen, PhD
study director · University of Medicine and Pharmacy at Ho Chi Minh City

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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