miRNAs in Periodontal Disease

NCT ID: NCT05046678

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-11-01

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.

Detailed Description

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Conditions

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Periodontal Diseases Periodontitis Gingivitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Periodontally healthy, non-smoking

Smokers with periodontally healthy

Intervention Type DIAGNOSTIC_TEST

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

Non-smokers with gingivitis

Intervention Type DIAGNOSTIC_TEST

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

Smokers with gingivitis

Intervention Type DIAGNOSTIC_TEST

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

Non-smokers with periodontitis

Intervention Type DIAGNOSTIC_TEST

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

Smokers with periodontitis

Intervention Type DIAGNOSTIC_TEST

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

Control

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Smokers with gingivitis

Intervention Type DIAGNOSTIC_TEST

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

Non-smokers with periodontitis

Intervention Type DIAGNOSTIC_TEST

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

Smokers with periodontitis

Intervention Type DIAGNOSTIC_TEST

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

Non-smokers with gingivitis

Gingivitis, non-smoking

Control

Intervention Type DIAGNOSTIC_TEST

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 periodontally healthy

Intervention Type DIAGNOSTIC_TEST

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

Smokers with gingivitis

Intervention Type DIAGNOSTIC_TEST

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

Non-smokers with periodontitis

Intervention Type DIAGNOSTIC_TEST

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

Smokers with periodontitis

Intervention Type DIAGNOSTIC_TEST

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 gingivitis

Gingivitis, smoking

Control

Intervention Type DIAGNOSTIC_TEST

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 periodontally healthy

Intervention Type DIAGNOSTIC_TEST

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

Non-smokers with gingivitis

Intervention Type DIAGNOSTIC_TEST

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

Non-smokers with periodontitis

Intervention Type DIAGNOSTIC_TEST

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

Smokers with periodontitis

Intervention Type DIAGNOSTIC_TEST

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

Non-smokers with periodontitis

Periodontitis, non-smoking

Control

Intervention Type DIAGNOSTIC_TEST

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 periodontally healthy

Intervention Type DIAGNOSTIC_TEST

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

Non-smokers with gingivitis

Intervention Type DIAGNOSTIC_TEST

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

Smokers with gingivitis

Intervention Type DIAGNOSTIC_TEST

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

Smokers with periodontitis

Intervention Type DIAGNOSTIC_TEST

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 periodontitis

Periodontitis, smoking

Control

Intervention Type DIAGNOSTIC_TEST

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 periodontally healthy

Intervention Type DIAGNOSTIC_TEST

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

Non-smokers with gingivitis

Intervention Type DIAGNOSTIC_TEST

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

Smokers with gingivitis

Intervention Type DIAGNOSTIC_TEST

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

Non-smokers with periodontitis

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bulent Ecevit University

OTHER

Sponsor Role lead

Responsible Party

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Figen Öngöz Dede

T.C. ORDU ÜNİVERSİTESİ

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ordu University

Ordu, In the USA Or Canada, Please Select..., Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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318S106

Identifier Type: -

Identifier Source: org_study_id

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