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

Primary Purpose

Periodontal Therapy, miRNA-223, Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
experimental-periodontitis-mirna-223-gingival tissue-saliva samples
control-clinical healthy mirna-223-gingival tissue-saliva samples
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Periodontal Therapy focused on measuring periodontal therapy, biomarker, periodontitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Biruni ÜniversitesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: periodontitis

Control: clinical healthy

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 29, 2022
Last Updated
May 17, 2022
Sponsor
Biruni University
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1. Study Identification

Unique Protocol Identification Number
NCT05372965
Brief Title
The Effects of Smoking on miRNA-223 Before-After Non-Surgical Periodontal Therapy in Patients With Stage-3, Grade-B Periodontitis
Official Title
The Effects of Smoking on miRNA-223 Before and After Non-Surgical Periodontal Therapy in Patients With Stage 3, Grade B Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Therapy, miRNA-223, Periodontitis, Biomarker
Keywords
periodontal therapy, biomarker, periodontitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Investigator
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: periodontitis
Arm Type
Experimental
Arm Description
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).
Arm Title
Control: clinical healthy
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
experimental-periodontitis-mirna-223-gingival tissue-saliva samples
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
control-clinical healthy mirna-223-gingival tissue-saliva samples
Intervention Description
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.
Primary Outcome Measure Information:
Title
Examination of miRNA-223 expressions, which are stated to be associated with periodontal disease, in saliva and gingival samples obtained from individuals with periodontitis,
Description
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.
Time Frame
During study (up to 1 year)
Title
Evaluation of the effect of non-surgical periodontal treatment on changes in miRNA-223 expressions,
Description
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.
Time Frame
4 weeks after the non surgical periodontal therapy
Title
Examining the effect of smoking, which is one of the main risk factors of periodontitis, on miRNA-223 levels and
Description
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.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
to determine which sample is more reliable by comparing miRNA-223 levels in saliva and tissue samples
Description
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.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleyna Eray
Phone
05389809449
Email
aleynaeray95@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Burcu Karaduman
Phone
05389809449
Email
bkaraduman@biruni.edu.tr
Facility Information:
Facility Name
Biruni Üniversitesi
City
Istanbul
State/Province
İstanbul, Zeytinburnu
ZIP/Postal Code
34025
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burcu Karaduman
Phone
05323763366
Email
bkaraduman@biruni.edu.tr
First Name & Middle Initial & Last Name & Degree
Aleyna Eray
Phone
05389809449
Email
aleynaeray95@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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