miRNAs in Periodontal Disease

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05046678
• Other study ID #: 318S106
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: September 2021
• Source: Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 1, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis
• Periodontal Diseases
• Periodontitis

Intervention

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 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
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
Turkey	Ordu University	Ordu	In The USA Or Canada, Please Select...

Sponsors (1)

Lead Sponsor	Collaborator
Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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