Effect of Non-Surgical Periodontal Treatment on Biomarker Levels

NCT ID: NCT06178081

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-07-01

Brief Summary

Periodontitis is a destructive disease that follows untreated gingivitis and is characterized by gingival inflammation, clinical attachment loss, alveolar bone loss and periodontal pocket formation, increased tooth mobility and tooth loss. Although the primary etiological factor is microbial dental plaque, the host response plays an important role in the transition from periodontal health to disease. Smoking is a major risk factor for periodontitis and affects the formation and severity of the disease and healing after periodontal treatment by changing the host response to plaque. Proinflammatory and antiinflammatory cytokines have an important role in the pathogenesis of periodontal disease. Among these cytokines, interleukin (IL)-1β, IL-10 and currently IL-39 have been associated with periodontal disease. Further studies with post-treatment longitudinal evaluation are needed to elucidate the functions of IL-39 and its possible role in the pathogenesis of periodontal diseases. In this study, it was aimed to investigate the effects of non-surgical periodontal treatment on salivary and gingival crevicular fluid (GCF) IL-39, IL-1β and IL-10 levels in smokers and non-smokers with Stage 3 Grade B periodontitis and periodontally healthy individuals, both smokers and non-smokers. To the best of our knowledge, there is no study investigating the effects of non-surgical periodontal treatment and smoking on IL-39.

50 individuals with periodontitis and 50 periodontally healthy individuals (total 100 individuals) will be included in our study, and these two groups will be divided into two sub-groups as smokers and non-smokers. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing), saliva and GCF samples will be taken from all individuals at the beginning of the study. Non-surgical periodontal treatment will be performed in individuals with periodontitis. Saliva and GCF samples will be collected before treatment. The clinical measurements, saliva and GCF collection will be repeated 12 weeks after the treatment. The saliva and GCF levels of IL-39, IL-1β and IL-10 will be analyzed by ELISA. Cotinine levels will be examined to evaluate the effects of smoking before and after treatment in periodontal health and periodontitis.

With this study, we aimed to develop IL-39 diagnostic kits for the diagnosis of periodontal diseases, detection of disease activity, follow-up of response to treatment and healing.

Conditions

Healthy; Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Clinical Healthy

Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) salivary sample and gingival crevicular fluid will be taken from all individuals at the beginning of the study. IL-39 and cotinine levels will be examined to evaluate the effects of smoking before and after treatment in periodontal health and periodontitis. A pre-treatment saliva sample and gingival crevicular fluid will be collected from the clinically healthy group.

Group Type: ACTIVE_COMPARATOR

Periodontal Healthy

Intervention Type: OTHER

Non surgical periodontal therapy

Periodontitis

Non-surgical periodontal treatment will be applied to individuals with periodontitis, clinical measurements, saliva collection and gingival crevicular fluid will be repeated 12 weeks after the treatment. IL-39 analysis will be performed by ELISA in saliva and gingival crevicular fluid of individuals. IL-39 and cotinine levels will be examined to evaluate the effects of smoking 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

Periodontal Healthy

Intervention Type: OTHER

Non surgical periodontal therapy

Interventions

Periodontal Healthy

Non surgical periodontal therapy

Intervention Type: OTHER

Other Intervention Names

Periodontitis

Eligibility Criteria

Inclusion Criteria

• Periodontal healthy group
• Stage III Grade B and C Periodontitis Group
• To meet the above-mentioned periodontal health and disease criteria

Exclusion Criteria

• Chronic alcohol use,
• Oral contraceptive use, pregnancy, pregnant,
• Last 6 months antibiotic or anti-inflammatory drug use,
• To have periodontal therapy in the last 6 months

• 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

Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Biruni University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2015-KAEK-79-23-08

Identifier Type: -

Identifier Source: org_study_id