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Periodontal DiseasesNCT06073613

Periodontal Status in Patients With Chronic Skin Diseases

An observational study of Periodontal Diseases and Psoriasis, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Periodontal Diseases, Psoriasis, Atopic Dermatitis
What is being tested?
oral health status
Type of treatment
Pill or oral medicine
How many people
146 participants
Where
1 siteVietnam
Study dates
20 Jan 2023to 28 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • Toothless
  • Limited mouth opening

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • University of Medicine and Pharmacy at Ho Chi Minh city

    Ho Chi Minh City, 70000

Other trials in Vietnam

About this study

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

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.

Being tested
oral health status
Keywords
chronic skin disease, periodontal status, oral lesions
Medical subject headings
Periodontal Diseases, Psoriasis, Dermatitis, Atopic, Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oral health statusDiagnostic test

    Also called CSDs medical records

    • 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
Study groups in NCT06073613
Study groupRoleWhat they receive
control grouphealthy individuals, aged 18 years or older and free of chronic skin diseases, willing to participate in the study
Receives: Diagnostic Test: oral health status
Patients with CSDsPatients 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
Receives: Diagnostic Test: oral health status

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

    Measured: Baseline

  4. debris index (DI)

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

    Measured: Baseline

  5. calculus index (CI)

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

    Measured: 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)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start20 Jan 2023
  3. Primary completion28 Feb 2023
  4. Study completion28 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06073613
Sponsor's protocol ID
HoChiMinhCityUMP_FOS
Status last verified
Oct 2023
First submitted
26 Sep 2023
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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

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

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontal Diseases and Psoriasis, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Full mouth bleeding on probing scores (BOP) (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06073613, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.

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