Effect of Non-Surgical Periodontal Treatment on Biomarker Levels

Healthy Clinical Trial

Official title:

Effect of Non-Surgical Periodontal Treatment on Biomarker Levels in Smoker and Non-Smoker Periodontitis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06178081
• Other study ID #: 2015-KAEK-79-23-08
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: December 2023
• Source: Biruni University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Periodontitis

Intervention

Other:
• Periodontal Healthy
Non surgical periodontal therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biruni University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison biomarkers of study groups.	Comparison of gingival crevicular fluid and saliva samples taken before treatment in individuals with periodontitis in terms of IL-39 levels.	up to 1 year
Primary	Examination of IL-39 levels of periodontal disease and clinically healthy	Examination of IL-39 levels, which are stated to be associated with periodontal disease, in gingival crevicular fluid and saliva samples obtained from individuals with periodontitis.	up to 1 year
Secondary	Evaluation of the effect of non-surgical periodontal treatment on changes in IL-39 level.	Evaluation of the effect of non-surgical periodontal treatment on changes in IL-39 level.	up to 1 year