The Effects of Smoking on miRNA-223 Before-After Non-Surgical Periodontal Therapy

NCT ID: NCT05372965

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-05
• Study Completion Date: 2023-12-12

Brief Summary

Periodontal diseases are one of the most common inflammatory diseases. Periodontal disease results from a complex interplay between the subgingival biofilm and the host immune-inflammatory events that develop in the gingival and periodontal tissues in response to the challenge presented by the bacteria. The net result of these inflammatory changes is the breakdown of the fibers of the periodontal ligament, resulting in clinical loss of attachment together with resorption of the alveolar bone. It is known that smoking is a major risk factor for periodontitis and affects the occurrence and severity of the disease and recovery after periodontal treatment by changing the host response to plaque. Biomarkers can be used to diagnose periodontitis early, to determine the rate of destruction, and also to evaluate the response to treatment. It has been reported that microRNAs (miRNAs) play an important role in development, homeostasis and immune functions, and abnormal miRNA expression may increase the severity of disease progression. It can be thought that early diagnosis can be achieved with the detection of miRNAs in patients with periodontitis, thus helping to prevent bone and tooth loss. To the best of our knowledge, there is no study in the literature investigating the effects of periodontal treatment and smoking on miRNAs in saliva or gingival samples. From this point of view, the aim of our study is to examine and compare miRNA-223 expressions in saliva and tissue samples before and after non-surgical periodontal treatment in individuals with periodontitis and to investigate the effect of smoking on miRNA-223 levels.

Materials-Methods: Our study will include 42 people with periodontitis and 42 healthy periodontal patients (84 individuals in total), and these two groups will be divided into two as smokers and non-smokers. 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. Non-surgical periodontal treatment will be applied to individuals with periodontitis, gingival samples will be collected during the treatment, clinical measurements and saliva collection will be repeated 6 weeks after the treatment. MiRNA-223 gene expression analysis will be performed by real-time PCR method in saliva and gingival samples of individuals. MiRNA-223 and cotinine levels will be examined to evaluate the effects of smoking before and after treatment in periodontal health and periodontitis.

With our study, it is aimed to better illuminate the role of miRNA-223 in periodontitis and also to determine which sample is more reliable by comparing miRNA-223 levels in saliva and tissue samples. Thus, the first step towards the development of diagnostic kits in the future will be taken.

Conditions

Periodontal Therapy; miRNA-223; Periodontitis; Biomarker

Study Design

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

Study Groups

Experimental: periodontitis

Our study will include 42 people with periodontitis patients and these two groups will be divided into two as smokers (21) and non-smokers (21).

Group Type: EXPERIMENTAL

experimental-periodontitis-mirna-223-gingival tissue-saliva samples

Intervention Type: OTHER

Non-surgical periodontal treatment will be applied to individuals with periodontitis, gingival samples will be collected during the treatment, clinical measurements and saliva collection will be repeated 6 weeks after the treatment. MiRNA-223 gene expression analysis will be performed by real-time PCR (Polymerase Chain Reaction) method in saliva and gingival samples of individuals. MiRNA-223 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.

Control: clinical healthy

Our study will include 42 people with clinical healthy patients and these two groups will be divided into two as smokers (21) and non-smokers (21).

Group Type: ACTIVE_COMPARATOR

control-clinical healthy mirna-223-gingival tissue-saliva samples

Intervention Type: OTHER

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. MiRNA-223 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 will be collected from the clinically healthy group. A tissue sample will be collected during the clinical crown lengthening operation.

Interventions

experimental-periodontitis-mirna-223-gingival tissue-saliva samples

Non-surgical periodontal treatment will be applied to individuals with periodontitis, gingival samples will be collected during the treatment, clinical measurements and saliva collection will be repeated 6 weeks after the treatment. MiRNA-223 gene expression analysis will be performed by real-time PCR (Polymerase Chain Reaction) method in saliva and gingival samples of individuals. MiRNA-223 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.

Intervention Type: OTHER

control-clinical healthy mirna-223-gingival tissue-saliva samples

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. MiRNA-223 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 will be collected from the clinically healthy group. A tissue sample will be collected during the clinical crown lengthening operation.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Periodontal tissues, periodontal disease course, periodontal application training and to have,
• Chronic alcohol use,
• Oral contraceptive use, pregnancy, pregnant,
• Last 6 system or anti-inflammatory drug use,
• To have developed periodontal in the last 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biruni University

OTHER

Sponsor Role: lead

Responsible Party

Burcu KARADUMAN

Doç. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Biruni Üniversitesi

Istanbul, İstanbul, Zeytinburnu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2015-KAEK-58-22-02

Identifier Type: -

Identifier Source: org_study_id