The Effects of Smoking on miRNA-223 Before-After Non-Surgical Periodontal Therapy in Patients With Stage-3, Grade-B Periodontitis

Periodontitis Clinical Trial

Official title:

The Effects of Smoking on miRNA-223 Before and After Non-Surgical Periodontal Therapy in Patients With Stage 3, Grade B Periodontitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05372965
• Other study ID #: 2015-KAEK-58-22-02
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: May 2022
• Source: Biruni University
• Contact: Aleyna Eray
• Phone: 05389809449
• Email: aleynaeray95[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 4 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Periodontal healthy group

• Stage III Grade B 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.

Related Conditions & MeSH terms

• Biomarker
• Periodontitis

Intervention

Other:
• 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 4 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 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.

Locations

Country	Name	City	State
Turkey	Biruni Üniversitesi	Istanbul	Istanbul, Zeytinburnu

Sponsors (1)

Lead Sponsor	Collaborator
Biruni University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examination of miRNA-223 expressions, which are stated to be associated with periodontal disease, in saliva and gingival samples obtained from individuals with 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.	During study (up to 1 year)
Primary	Evaluation of the effect of non-surgical periodontal treatment on changes in miRNA-223 expressions,	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 4 weeks after the treatment.	4 weeks after the non surgical periodontal therapy
Primary	Examining the effect of smoking, which is one of the main risk factors of periodontitis, on miRNA-223 levels and	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.	through study completion, an average of 1 year
Secondary	to determine which sample is more reliable by comparing miRNA-223 levels in saliva and tissue samples	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.	through study completion, an average of 1 year