NCT07821528

Brief Summary

Aim: This study explores the connection between Behçet's disease (BD), characterized by persistent oral and genital ulcers alongside iritis, and periodontal disease. It examines the levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and nitric oxide (NO) in gingival crevicular fluid (GCF) and saliva. Methods: Forty Behçet's patients with gingivitis or periodontitis and 47 patients with either gingivitis or periodontitis but without BD were studied. Periodontal status was recorded with standard clinical indexes. GCF and saliva samples were obtained. NO, IL-1β and TNF-α levels were analysed. Current Behçet's symptoms and medications usage were recorded.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

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

February 16, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2019

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2024

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

July 19, 2024

Last Update Submit

September 9, 2026

Conditions

Keywords

Gingival crevicular fluidSalivaCytokine

Outcome Measures

Primary Outcomes (2)

  • The amount of salivary interleukin-1 beta, TNF alpha, Nitric Oxide

    Saliva sampling was performed before the periodontal examination and GCF collection. For each patient, unstimulated whole mixed saliva was collected using a modified method. Participants were asked to rinse her/his mouth with water for a minute, 10 min before the sampling. The saliva samples were collected into a sterile plastic container for 5 min.

    baseline

  • The amount of gingival crevicular fluid interleukin-1 beta, TNF alpha, Nitric Oxide

    The gingival crevicular fluid sampling site was gently air dried and supragingival plaque was removed. The area was carefully isolated with cotton rolls in order to prevent from contamination. Standardized paper strips (Periopaper, OraFlow, Amityville, NY, USA) were inserted into the sulcus until slight resistance was felt and left in place for 30 seconds.

    baseline

Study Arms (4)

Behçet's patients with gingivitis

26 patients Gingivitis was diagnosed as according to a BOP score ≥ 10%, without attachment loss and radiographic bone loss

Diagnostic Test: Periodontal clinical indexes, saliva, gingival crevicular fluid sampling

Behçet's patients with periodontitis

14 patients Periodontitis was diagnosed with a severity of Stage II, pocket depth 3-4 mm and Stage III, pocket depth ≥5 mm, a generalized pattern according to the criteria by the criteria 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. Patients were diagnosed according to the International Criteria for Behçet's Disease (ICBD). ICBD is based on ocular lesions, genital ulcers, oral aphthous ulcers, skin manifestations, vascular involvement and positive pathergy test. Systemic involvement associated with BD, current symptoms and the use of any systemic medications were recorded.

Diagnostic Test: Periodontal clinical indexes, saliva, gingival crevicular fluid sampling

Systemically Healthy patients with gingivitis

24 patients Gingivitis was diagnosed as according to a BOP score ≥ 10%, without attachment loss and radiographic bone loss Patients were diagnosed according to the International Criteria for Behçet's Disease (ICBD). ICBD is based on ocular lesions, genital ulcers, oral aphthous ulcers, skin manifestations, vascular involvement and positive pathergy test. Systemic involvement associated with BD, current symptoms and the use of any systemic medications were recorded.

Diagnostic Test: Periodontal clinical indexes, saliva, gingival crevicular fluid sampling

Systemically Healthy patients with periodontitis

23 patients Periodontitis was diagnosed with a severity of Stage II, pocket depth 3-4 mm and Stage III, pocket depth ≥5 mm, a generalized pattern according to the criteria by the criteria 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.

Diagnostic Test: Periodontal clinical indexes, saliva, gingival crevicular fluid sampling

Interventions

Behçet's patients with gingivitisBehçet's patients with periodontitisSystemically Healthy patients with gingivitisSystemically Healthy patients with periodontitis

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The participants were divided into 4 groups; systemically healthy patients with gingivitis (HG), systemically healthy patients with periodontitis (HP), BD patients with gingivitis (BG), and BD patients with periodontitis (BP).

You may qualify if:

  • No systemic diseases for the controls
  • Aged 21 years older
  • A diagnosis of Behcet disease according to the diagnostic criteria
  • Presence at least 20 natural teeth
  • Ability to undergo a full mouth periodontal examination
  • Availability of clinical information regarding Behcet disease duration, disease activity, organ involvement, current medications

You may not qualify if:

  • Other autoimmun systemic diseases
  • Pregnancy and lactation
  • Periodontal treatment within the previous 3-6 months Use of antibiotics within the previous 3 months
  • Fewer than 20 teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Akman A, Ekinci NC, Kacaroglu H, Yavuzer U, Alpsoy E, Yegin O. Relationship between periodontal findings and specific polymorphisms of interleukin-1alpha and -1beta in Turkish patients with Behcet's disease. Arch Dermatol Res. 2008 Jan;300(1):19-26. doi: 10.1007/s00403-007-0794-1. Epub 2007 Oct 25.

  • Mumcu G, Ergun T, Inanc N, Fresko I, Atalay T, Hayran O, Direskeneli H. Oral health is impaired in Behcet's disease and is associated with disease severity. Rheumatology (Oxford). 2004 Aug;43(8):1028-33. doi: 10.1093/rheumatology/keh236. Epub 2004 May 25.

MeSH Terms

Conditions

Behcet SyndromePeriodontitisGingival Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VascularPeriodontal Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 19, 2024

First Posted

September 16, 2026

Study Start

February 16, 2016

Primary Completion

February 16, 2018

Study Completion

February 18, 2019

Last Updated

September 16, 2026

Record last verified: 2026-09