Clinical trial NCT06073613: Periodontal Status in Patients With Chronic Skin Diseases
Official title: Periodontal Status in Patients With Chronic Skin Diseases: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Psoriasis
Atopic Dermatitis
Autoimmune Bullous Dermatosis
Systemic Lupus Erythematosus
Keywords: chronic skin disease
periodontal status
oral lesions
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Full mouth bleeding on probing scores (BOP)
timeFrame: baseline
measure: Pocket probing depth (PPD)
timeFrame: baseline
measure: Clinical attachment level (CAL)
timeFrame: Baseline
measure: debris index (DI)
timeFrame: Baseline
measure: calculus index (CI)
timeFrame: Baseline
measure: the number of oral lesions
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University of Medicine and Pharmacy at Ho Chi Minh city
Study officials:
affiliation: Ho Chi Minh City Hospital of Dermato-Venereology, Ho Chi Minh City, Vietnam
name: Hao Trong Nguyen, PhD
role: STUDY_DIRECTOR
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Thuy Thu Nguyen, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Listgarten MA. Pathogenesis of periodontitis. J Clin Periodontol. 1986 May;13(5):418-30. doi: 10.1111/j.1600-051x.1986.tb01485.x.
citation: 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.
citation: 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.
citation: 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.