miRNAs in Periodontal Disease

Effects of Smoking on Saliva MicroRNAs Before and After Non-Surgical Periodontal Therapy in Patients With Periodontal Disease

It has been stated that microRNA (miRNA) play an important role in development, homeostasis and immune functions, and abnormal miRNA expression may cause faster disease progression. The aim of this study was to determine miR-203, miR-142-3p, miR-146a, miR-146b, miR-155, miR-29b gene expressions in saliva of the patients with periodontal disease before and after non-surgical periodontal therapy (NSPT) and to evaluate the effect of smoking on these miRNAs. A total of 90 individuals, 30 with periodontitis, 30 with gingivitis, and 30 periodontally healthy (control group), were included. These three groups were divided into subgroups as smoking and non-smoking individuals, with 15 people in each group. NSPT was applied to patients with periodontitis and gingivitis. Saliva samples and clinical parameters were taken from at baseline and repeated 6 weeks after NSPT.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Periodontal Diseases; Gingivitis
• Intervention / Treatment: Diagnostic test: Smokers with periodontally healthy; Diagnostic test: Non-smokers with gingivitis; Diagnostic test: Smokers with gingivitis; Diagnostic test: Non-smokers with periodontitis; Diagnostic test: Smokers with periodontitis; Diagnostic test: Control

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Turkey
  • In The USA Or Canada, Please Select...
    • Ordu, In The USA Or Canada, Please Select..., Turkey, 52100
      • Ordu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

1. group (Control): Periodontally and systemically healthy and non-smoking
2. group: Periodontally and systemically healthy and smoking
3. group: Gingivitis, Systemically healthy and non-smoking
4. group: Gingivitis, Systemically healthy and smoking
5. group: Periodontitis, Systemically healthy and non-smoking
6. group: Periodontitis, Systemically healthy and smoking

Description

Inclusion Criteria:

Have at least 20 natural teeth, excluding third molars. Periodontitis patients had at least two non-adjacent sites per quadrant with probing depth (PD) ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm with gingival inflammation, and alveolar bone loss affecting >30% of the teeth, as detected on clinical and radiographical examinations.

Gingivitis patients had without attachment and alveolar bone loss who had gingival inflammation, PD ≤ 3 mm and BOP > 30% in the entire mouth Periodontally healthy control group had no sign of gingival inflammation, no PD > 3mm and no evidence of attachment or bone loss

Exclusion Criteria:

History of systemic disease. Regular use of any drugs which can effect the immune system or inflammatory response in the 6 months preceding the start of the study.

Periodontal treatment during last 6 months that could affect periodontal status.

History of radiotherapy or chemotherapy. Current pregnancy, lactation or menopause.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Periodontally healthy, non-smoking	Diagnostic test: Smokers with periodontally healthy; probing pocket depth (PPD)≤ 3 mm (presence of normal gingival sulcus), bleeding on probing (BOP) < 10%, clinical absence of periodontal inflammation, radiological bone loss, and any prior periodontal disease, additionally presence of anatomically intact periodontium and smokers if they had smoked ≥10 cigarettes/day for ≥5 years; Diagnostic test: Non-smokers with gingivitis; without attachment and alveolar bone loss who had gingival inflammation, PD ≤ 3 mm and BOP > 30% in the full mouth and nonsmokers if they had no previous history of smoking; Diagnostic test: Smokers with gingivitis; without attachment and alveolar bone loss who had gingival inflammation, PD ≤ 3 mm and BOP > 30% in the full mouth and smokers if they had smoked ≥10 cigarettes/day for ≥5 years; Diagnostic test: Non-smokers with periodontitis; interdental clinical attachment level (CAL) ≥ 5 mm and PPD ≥ 6 mm on at least two non-adjacent teeth, bone loss involving the middle or apical third of the root radiographically, moderate ridge defect and ≥30% of teeth and nonsmokers if they had no previous history of smoking; Diagnostic test: Smokers with periodontitis; interdental clinical attachment level (CAL) ≥ 5 mm and PPD ≥ 6 mm on at least two non-adjacent teeth, bone loss involving the middle or apical third of the root radiographically, moderate ridge defect and ≥30% of teeth and smokers if they had smoked ≥10 cigarettes/day for ≥5 years
Smokers with periodontally healthy; Periodontally healthy, smoking	Diagnostic test: Non-smokers with gingivitis; without attachment and alveolar bone loss who had gingival inflammation, PD ≤ 3 mm and BOP > 30% in the full mouth and nonsmokers if they had no previous history of smoking; Diagnostic test: Smokers with gingivitis; without attachment and alveolar bone loss who had gingival inflammation, PD ≤ 3 mm and BOP > 30% in the full mouth and smokers if they had smoked ≥10 cigarettes/day for ≥5 years; Diagnostic test: Non-smokers with periodontitis; interdental clinical attachment level (CAL) ≥ 5 mm and PPD ≥ 6 mm on at least two non-adjacent teeth, bone loss involving the middle or apical third of the root radiographically, moderate ridge defect and ≥30% of teeth and nonsmokers if they had no previous history of smoking; Diagnostic test: Smokers with periodontitis; interdental clinical attachment level (CAL) ≥ 5 mm and PPD ≥ 6 mm on at least two non-adjacent teeth, bone loss involving the middle or apical third of the root radiographically, moderate ridge defect and ≥30% of teeth and smokers if they had smoked ≥10 cigarettes/day for ≥5 years; Diagnostic test: Control; probing pocket depth (PPD)≤ 3 mm (presence of normal gingival sulcus), bleeding on probing (BOP) < 10%, clinical absence of periodontal inflammation, radiological bone loss, and any prior periodontal disease, additionally presence of anatomically intact periodontium and nonsmokers if they had no previous history of smoking
Non-smokers with gingivitis; Gingivitis, non-smoking	Diagnostic test: Smokers with periodontally healthy; probing pocket depth (PPD)≤ 3 mm (presence of normal gingival sulcus), bleeding on probing (BOP) < 10%, clinical absence of periodontal inflammation, radiological bone loss, and any prior periodontal disease, additionally presence of anatomically intact periodontium and smokers if they had smoked ≥10 cigarettes/day for ≥5 years; Diagnostic test: Smokers with gingivitis; without attachment and alveolar bone loss who had gingival inflammation, PD ≤ 3 mm and BOP > 30% in the full mouth and smokers if they had smoked ≥10 cigarettes/day for ≥5 years; Diagnostic test: Non-smokers with periodontitis; interdental clinical attachment level (CAL) ≥ 5 mm and PPD ≥ 6 mm on at least two non-adjacent teeth, bone loss involving the middle or apical third of the root radiographically, moderate ridge defect and ≥30% of teeth and nonsmokers if they had no previous history of smoking; Diagnostic test: Smokers with periodontitis; interdental clinical attachment level (CAL) ≥ 5 mm and PPD ≥ 6 mm on at least two non-adjacent teeth, bone loss involving the middle or apical third of the root radiographically, moderate ridge defect and ≥30% of teeth and smokers if they had smoked ≥10 cigarettes/day for ≥5 years; Diagnostic test: Control; probing pocket depth (PPD)≤ 3 mm (presence of normal gingival sulcus), bleeding on probing (BOP) < 10%, clinical absence of periodontal inflammation, radiological bone loss, and any prior periodontal disease, additionally presence of anatomically intact periodontium and nonsmokers if they had no previous history of smoking
Smokers with gingivitis; Gingivitis, smoking	Diagnostic test: Smokers with periodontally healthy; probing pocket depth (PPD)≤ 3 mm (presence of normal gingival sulcus), bleeding on probing (BOP) < 10%, clinical absence of periodontal inflammation, radiological bone loss, and any prior periodontal disease, additionally presence of anatomically intact periodontium and smokers if they had smoked ≥10 cigarettes/day for ≥5 years; Diagnostic test: Non-smokers with gingivitis; without attachment and alveolar bone loss who had gingival inflammation, PD ≤ 3 mm and BOP > 30% in the full mouth and nonsmokers if they had no previous history of smoking; Diagnostic test: Non-smokers with periodontitis; interdental clinical attachment level (CAL) ≥ 5 mm and PPD ≥ 6 mm on at least two non-adjacent teeth, bone loss involving the middle or apical third of the root radiographically, moderate ridge defect and ≥30% of teeth and nonsmokers if they had no previous history of smoking; Diagnostic test: Smokers with periodontitis; interdental clinical attachment level (CAL) ≥ 5 mm and PPD ≥ 6 mm on at least two non-adjacent teeth, bone loss involving the middle or apical third of the root radiographically, moderate ridge defect and ≥30% of teeth and smokers if they had smoked ≥10 cigarettes/day for ≥5 years; Diagnostic test: Control; probing pocket depth (PPD)≤ 3 mm (presence of normal gingival sulcus), bleeding on probing (BOP) < 10%, clinical absence of periodontal inflammation, radiological bone loss, and any prior periodontal disease, additionally presence of anatomically intact periodontium and nonsmokers if they had no previous history of smoking
Non-smokers with periodontitis; Periodontitis, non-smoking	Diagnostic test: Smokers with periodontally healthy; probing pocket depth (PPD)≤ 3 mm (presence of normal gingival sulcus), bleeding on probing (BOP) < 10%, clinical absence of periodontal inflammation, radiological bone loss, and any prior periodontal disease, additionally presence of anatomically intact periodontium and smokers if they had smoked ≥10 cigarettes/day for ≥5 years; Diagnostic test: Non-smokers with gingivitis; without attachment and alveolar bone loss who had gingival inflammation, PD ≤ 3 mm and BOP > 30% in the full mouth and nonsmokers if they had no previous history of smoking; Diagnostic test: Smokers with gingivitis; without attachment and alveolar bone loss who had gingival inflammation, PD ≤ 3 mm and BOP > 30% in the full mouth and smokers if they had smoked ≥10 cigarettes/day for ≥5 years; Diagnostic test: Smokers with periodontitis; interdental clinical attachment level (CAL) ≥ 5 mm and PPD ≥ 6 mm on at least two non-adjacent teeth, bone loss involving the middle or apical third of the root radiographically, moderate ridge defect and ≥30% of teeth and smokers if they had smoked ≥10 cigarettes/day for ≥5 years; Diagnostic test: Control; probing pocket depth (PPD)≤ 3 mm (presence of normal gingival sulcus), bleeding on probing (BOP) < 10%, clinical absence of periodontal inflammation, radiological bone loss, and any prior periodontal disease, additionally presence of anatomically intact periodontium and nonsmokers if they had no previous history of smoking
Smokers with periodontitis; Periodontitis, smoking	Diagnostic test: Smokers with periodontally healthy; probing pocket depth (PPD)≤ 3 mm (presence of normal gingival sulcus), bleeding on probing (BOP) < 10%, clinical absence of periodontal inflammation, radiological bone loss, and any prior periodontal disease, additionally presence of anatomically intact periodontium and smokers if they had smoked ≥10 cigarettes/day for ≥5 years; Diagnostic test: Non-smokers with gingivitis; without attachment and alveolar bone loss who had gingival inflammation, PD ≤ 3 mm and BOP > 30% in the full mouth and nonsmokers if they had no previous history of smoking; Diagnostic test: Smokers with gingivitis; without attachment and alveolar bone loss who had gingival inflammation, PD ≤ 3 mm and BOP > 30% in the full mouth and smokers if they had smoked ≥10 cigarettes/day for ≥5 years; Diagnostic test: Non-smokers with periodontitis; interdental clinical attachment level (CAL) ≥ 5 mm and PPD ≥ 6 mm on at least two non-adjacent teeth, bone loss involving the middle or apical third of the root radiographically, moderate ridge defect and ≥30% of teeth and nonsmokers if they had no previous history of smoking; Diagnostic test: Control; probing pocket depth (PPD)≤ 3 mm (presence of normal gingival sulcus), bleeding on probing (BOP) < 10%, clinical absence of periodontal inflammation, radiological bone loss, and any prior periodontal disease, additionally presence of anatomically intact periodontium and nonsmokers if they had no previous history of smoking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
miRNAs gene expressions in the periodontal disease	miR-203, miR-142-3p, miR-146a, miR-146b, miR-155, miR-29b gene expressions in saliva	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
miRNAs gene expressions in the periodontal disease	miR-203, miR-142-3p, miR-146a, miR-146b, miR-155, miR-29b gene expressions in saliva before and after non-surgical periodontal treatment	baseline and 6 weeks after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
miRNAs gene expressions in the periodontal disease	miR-203, miR-142-3p, miR-146a, miR-146b, miR-155, miR-29b gene expressions in saliva of the individials with smokers and nonsmokers	baseline and 6 weeks after treatment

Collaborators and Investigators

• Sponsor: Bulent Ecevit University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Mouth Diseases; Gingival Diseases; Periodontitis; Gingivitis; Periodontal Diseases
• Other Study ID Numbers: 318S106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No