NCT06073613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1 month

First QC Date

September 26, 2023

Last Update Submit

October 5, 2023

Conditions

Keywords

chronic skin diseaseperiodontal statusoral lesions

Outcome Measures

Primary Outcomes (6)

  • 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

    baseline

  • 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

    baseline

  • 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

    Baseline

  • debris index (DI)

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

    Baseline

  • calculus index (CI)

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

    Baseline

  • the number of oral lesions

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

    Baseline

Study Arms (2)

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

oral health statusDIAGNOSTIC_TEST

* 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
Patients with CSDscontrol group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Toothless
  • Limited mouth opening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Medicine and Pharmacy at Ho Chi Minh city

Ho Chi Minh City, 70000, Vietnam

Location

Related Publications (14)

  • 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.

    PMID: 20659265BACKGROUND
  • 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.

    PMID: 23900791BACKGROUND
  • 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.

    PMID: 19735453BACKGROUND
  • 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.

    PMID: 10561718BACKGROUND
  • 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.

    PMID: 19905946BACKGROUND
  • 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.

    PMID: 20881339BACKGROUND
  • 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.

    PMID: 16512754BACKGROUND
  • 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.

    PMID: 28038889BACKGROUND
  • 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.

    PMID: 32884621BACKGROUND
  • 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.

    PMID: 27629852BACKGROUND
  • Listgarten MA. Pathogenesis of periodontitis. J Clin Periodontol. 1986 May;13(5):418-30. doi: 10.1111/j.1600-051x.1986.tb01485.x.

    PMID: 3522650BACKGROUND
  • 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.

    PMID: 29539680BACKGROUND
  • 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.

    PMID: 14076341BACKGROUND
  • 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.

MeSH Terms

Conditions

Periodontal DiseasesPsoriasisDermatitis, AtopicLupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesConnective Tissue DiseasesAutoimmune Diseases

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Inverstigator

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 10, 2023

Study Start

January 20, 2023

Primary Completion

February 28, 2023

Study Completion

April 28, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations