miRNAs in Periodontal Disease

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 25 to 55 years
• All sexes
• Healthy volunteers accepted
• Adult

Study population: 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

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Periodontal Diseases, Periodontitis, Gingivitis

Being tested

Control, Smokers with periodontally healthy, Non-smokers with gingivitis, Smokers with gingivitis, Non-smokers with periodontitis

Medical subject headings

Periodontal Diseases, Periodontitis, Gingivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• ControlDiagnostic 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 healthyDiagnostic 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 gingivitisDiagnostic 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 gingivitisDiagnostic 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 periodontitisDiagnostic 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 periodontitisDiagnostic 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

   Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted16 Sep 2021
2. Study start1 Mar 2019
3. Primary completion1 Sep 2019
4. Study completion1 Nov 2020

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.