miRNAs in Periodontal Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Periodontal Diseases, Periodontitis, Gingivitis

Intervention / Treatment
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* Diagnostic Test: Control
* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Periodontally healthy, non-smoking | Diagnostic Test: Smokers with periodontally healthy<br>* 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<br>Diagnostic Test: Non-smokers with gingivitis<br>* 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<br>Diagnostic Test: Smokers with gingivitis<br>* 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<br>Diagnostic Test: Non-smokers with periodontitis<br>* 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<br>Diagnostic Test: Smokers with periodontitis<br>* 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<br>|
| Smokers with periodontally healthy<br>Periodontally healthy, smoking | Diagnostic Test: Control<br>* 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<br>Diagnostic Test: Non-smokers with gingivitis<br>* 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<br>Diagnostic Test: Smokers with gingivitis<br>* 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<br>Diagnostic Test: Non-smokers with periodontitis<br>* 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<br>Diagnostic Test: Smokers with periodontitis<br>* 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<br>|
| Non-smokers with gingivitis<br>Gingivitis, non-smoking | Diagnostic Test: Control<br>* 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<br>Diagnostic Test: Smokers with periodontally healthy<br>* 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<br>Diagnostic Test: Smokers with gingivitis<br>* 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<br>Diagnostic Test: Non-smokers with periodontitis<br>* 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<br>Diagnostic Test: Smokers with periodontitis<br>* 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<br>|
| Smokers with gingivitis<br>Gingivitis, smoking | Diagnostic Test: Control<br>* 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<br>Diagnostic Test: Smokers with periodontally healthy<br>* 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<br>Diagnostic Test: Non-smokers with gingivitis<br>* 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<br>Diagnostic Test: Non-smokers with periodontitis<br>* 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<br>Diagnostic Test: Smokers with periodontitis<br>* 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<br>|
| Non-smokers with periodontitis<br>Periodontitis, non-smoking | Diagnostic Test: Control<br>* 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<br>Diagnostic Test: Smokers with periodontally healthy<br>* 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<br>Diagnostic Test: Non-smokers with gingivitis<br>* 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<br>Diagnostic Test: Smokers with gingivitis<br>* 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<br>Diagnostic Test: Smokers with periodontitis<br>* 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<br>|
| Smokers with periodontitis<br>Periodontitis, smoking | Diagnostic Test: Control<br>* 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<br>Diagnostic Test: Smokers with periodontally healthy<br>* 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<br>Diagnostic Test: Non-smokers with gingivitis<br>* 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<br>Diagnostic Test: Smokers with gingivitis<br>* 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<br>Diagnostic Test: Non-smokers with periodontitis<br>* 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<br>|

What is the study measuring?
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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 |