The Effect of Non-Surgical Periodontal Therapy on Inflammatory Bowel Disease

NCT ID: NCT06245278

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-10-01

Brief Summary

Inflammatory bowel disease (IBD) is a chronic and recurrent inflammatory disease of the gastrointestinal tract characterised by complex interactions between genetic susceptibility, environmental factors, microbiota and host immune response. It has two main forms, Crohn's disease (CD) and Ulcerative colitis (UC). The main mechanism of IBD pathogenesis is dysregulated host immune response to commensal microbiota and disruption of the balance of pro- and anti-inflammatory cytokines in genetically predisposed individuals. Periodontitis is a multifactorial inflammatory disease associated with dental biofilm resulting in the loss of periodontal supporting tissues and subsequently teeth. Although the occurrence of the disease depends on multifactorial factors, bacterial plaque is the primary etiological factor and various bacterial species found in plaque are responsible for initiating and maintaining the inflammatory and immune response in periodontal disease. Periodontal diseases are known to contribute to many systemic diseases/conditions or systemic disorders are known to affect periodontal disease. Although the relationship between IBD and periodontitis is based on the potential link between oral and intestinal microbiomes and host immunoinflammatory response, the pathological interactions between the two diseases have not yet been determined. From this point of view, the aim of our study was to investigate the effect of periodontal status on serum, saliva and gingival biomarkers (TIM-3, TNF-α, IL-6 and IL-17) in patients with IBD and to evaluate the relationship between these values and periodontal clinical parameters. This is the first study to examine TIM-3 levels in saliva, serum and gingival samples in patients with IBD and periodontitis with IBD.

Conditions

Periodontitis; Inflammatory Bowel Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Clinical Healthy

Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) salivary sample and serum will be taken from all individuals at the beginning of the study. TIM-3 levels will be examined to evaluate before and after treatment in periodontal health and periodontitis. A pre-treatment saliva sample and serum will be collected from the clinically healthy group.

Group Type: EXPERIMENTAL

ELISA (Enzyme-Linked ImmunoSorbent Assay)

Intervention Type: OTHER

A total of 60 individuals, 15 with IBD and periodontitis, 15 with IBD and periodontal health, 15 with systemic health and periodontitis, and 15 with systemic and periodontal health, will be included in the study. At the beginning of the study, periodontal clinical measurements (gingival index, plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and serum, saliva and gingival samples will be obtained from all individuals. Individuals with periodontitis will receive non-surgical periodontal treatment in half jaws within 2 weeks. Clinical measurements, serum and saliva sample collection will be repeated 3 months after the treatment. Biomarker levels in serum and saliva samples will be analysed by ELISA.

Periodontitis

Non-surgical periodontal treatment will be applied to individuals with periodontitis, clinical measurements, saliva collection and serum will be repeated 12 weeks after the treatment. TIM-3 analysis will be performed by ELISA in saliva and serum of individuals. TIM-3 levels will be examined to evaluate before and after treatment in periodontal health and periodontitis. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and salivary sample will be taken from all individuals at the beginning of the study.

Group Type: EXPERIMENTAL

ELISA (Enzyme-Linked ImmunoSorbent Assay)

Intervention Type: OTHER

A total of 60 individuals, 15 with IBD and periodontitis, 15 with IBD and periodontal health, 15 with systemic health and periodontitis, and 15 with systemic and periodontal health, will be included in the study. At the beginning of the study, periodontal clinical measurements (gingival index, plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and serum, saliva and gingival samples will be obtained from all individuals. Individuals with periodontitis will receive non-surgical periodontal treatment in half jaws within 2 weeks. Clinical measurements, serum and saliva sample collection will be repeated 3 months after the treatment. Biomarker levels in serum and saliva samples will be analysed by ELISA.

Periodontitis with İnflammatory Bowel Disease

Non-surgical periodontal treatment will be applied to individuals with periodontitis, clinical measurements, saliva collection and serum will be repeated 12 weeks after the treatment. TIM-3 analysis will be performed by ELISA in saliva and serum of individuals. TIM-3 levels will be examined to evaluate before and after treatment in periodontitis with İnflammatory Bowel Disease. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and salivary sample will be taken from all individuals at the beginning of the study.

Group Type: EXPERIMENTAL

ELISA (Enzyme-Linked ImmunoSorbent Assay)

Intervention Type: OTHER

A total of 60 individuals, 15 with IBD and periodontitis, 15 with IBD and periodontal health, 15 with systemic health and periodontitis, and 15 with systemic and periodontal health, will be included in the study. At the beginning of the study, periodontal clinical measurements (gingival index, plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and serum, saliva and gingival samples will be obtained from all individuals. Individuals with periodontitis will receive non-surgical periodontal treatment in half jaws within 2 weeks. Clinical measurements, serum and saliva sample collection will be repeated 3 months after the treatment. Biomarker levels in serum and saliva samples will be analysed by ELISA.

Healthy individuals with İnflammatory Bowel Disease

Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) salivary sample and serum will be taken from all individuals at the beginning of the study. TIM-3 levels will be examined to evaluate before and after treatment in periodontal health and periodontitis. A pre-treatment saliva sample and serum will be collected from the healthy individuals with İnflammatory Bowel Disease group.

Group Type: EXPERIMENTAL

ELISA (Enzyme-Linked ImmunoSorbent Assay)

Intervention Type: OTHER

A total of 60 individuals, 15 with IBD and periodontitis, 15 with IBD and periodontal health, 15 with systemic health and periodontitis, and 15 with systemic and periodontal health, will be included in the study. At the beginning of the study, periodontal clinical measurements (gingival index, plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and serum, saliva and gingival samples will be obtained from all individuals. Individuals with periodontitis will receive non-surgical periodontal treatment in half jaws within 2 weeks. Clinical measurements, serum and saliva sample collection will be repeated 3 months after the treatment. Biomarker levels in serum and saliva samples will be analysed by ELISA.

Interventions

ELISA (Enzyme-Linked ImmunoSorbent Assay)

A total of 60 individuals, 15 with IBD and periodontitis, 15 with IBD and periodontal health, 15 with systemic health and periodontitis, and 15 with systemic and periodontal health, will be included in the study. At the beginning of the study, periodontal clinical measurements (gingival index, plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and serum, saliva and gingival samples will be obtained from all individuals. Individuals with periodontitis will receive non-surgical periodontal treatment in half jaws within 2 weeks. Clinical measurements, serum and saliva sample collection will be repeated 3 months after the treatment. Biomarker levels in serum and saliva samples will be analysed by ELISA.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• To be between the ages of 18-65,
• Having at least 8 teeth excluding wisdom teeth,
• No periodontal treatment in the last 3 months,
• Not having used antibiotics in the last 3 months,
• Not being pregnant or breastfeeding,
• The individuals to be included in the control group should not have any systemic disease that may change the periodontal status, and the individuals to be included in the experimental group should not have any systemic disease that may affect periodontal health except IBD.

Exclusion Criteria

• Under 18 years of age and over 65 years of age,
• Having less than 8 teeth,
• Having undergone periodontal treatment in the last 3 months,
• Having used antibiotics in the last 3 months,
• Being pregnant or breastfeeding,
• Individuals to be included in the control group should have any systemic disease that may change the periodontal status, and individuals to be included in the test group should have any systemic disease that may affect periodontal health except IBD.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biruni University

OTHER

Sponsor Role: lead

Responsible Party

Burcu KARADUMAN

Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Biruni University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2015-KAEK-80-23-03

Identifier Type: -

Identifier Source: org_study_id