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Completed

NCT Number: NCT05046678

miRNAs in 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.

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Key information

Conditions

Periodontal Diseases Gingival Diseases Gingivitis Infections Mouth Diseases Periodontitis Stomatognathic Diseases

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ordu University

Ordu, In the USA Or Canada, Please Select..., 52100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control

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

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

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

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

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

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

Primary outcomes

  1. miRNAs gene expressions in the periodontal disease

    Time frame: baseline

    miR-203, miR-142-3p, miR-146a, miR-146b, miR-155, miR-29b gene expressions in saliva

Secondary outcomes

  1. miRNAs gene expressions in the periodontal disease

    Time frame: baseline and 6 weeks after treatment

    miR-203, miR-142-3p, miR-146a, miR-146b, miR-155, miR-29b gene expressions in saliva before and after non-surgical periodontal treatment

Other outcomes

  1. miRNAs gene expressions in the periodontal disease

    Time frame: baseline and 6 weeks after treatment

    miR-203, miR-142-3p, miR-146a, miR-146b, miR-155, miR-29b gene expressions in saliva of the individials with smokers and nonsmokers

Sponsors and collaborators

Lead sponsor

Bulent Ecevit University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Sep 16, 2021
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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