miRNAs in Periodontal Disease
Effects of Smoking on Saliva MicroRNAs Before and After Non-Surgical Periodontal Therapy in Patients With Periodontal Disease
1 other identifier
observational
90
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 13, 2021
CompletedFirst Posted
Study publicly available on registry
September 16, 2021
CompletedSeptember 16, 2021
September 1, 2021
6 months
September 13, 2021
September 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
miRNAs gene expressions in the periodontal disease
baseline and 6 weeks after treatment
Other Outcomes (1)
miRNAs gene expressions in the periodontal disease
baseline and 6 weeks after treatment
Study Arms (6)
Control
Periodontally healthy, non-smoking
Smokers with periodontally healthy
Periodontally healthy, smoking
Non-smokers with gingivitis
Gingivitis, non-smoking
Smokers with gingivitis
Gingivitis, smoking
Non-smokers with periodontitis
Periodontitis, non-smoking
Smokers with periodontitis
Periodontitis, smoking
Interventions
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
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
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
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
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
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
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ordu University
Ordu, In the USA Or Canada, Please Select..., 52100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- T.C. ORDU ÜNİVERSİTESİ
Study Record Dates
First Submitted
September 13, 2021
First Posted
September 16, 2021
Study Start
March 1, 2019
Primary Completion
September 1, 2019
Study Completion
November 1, 2020
Last Updated
September 16, 2021
Record last verified: 2021-09