Periodontitis Clinical Trial
Official title:
Validation of the Clinical and Antimicrobial Effectiveness of a Clorexidine and Sodium DNA Based Mouthwash in Patients With Stage III and IV Periodontitis: a Randomized-controlled Clinical Trial
NCT number | NCT06028867 |
Other study ID # | 121-29 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 24, 2020 |
Est. completion date | April 20, 2024 |
Verified date | May 2024 |
Source | University of Catania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Sodium DNA has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. The aim of this RCT study is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine 0.12% + Sodium DNA and Chlorhexidine 0.20% at two weeks, compared with a placebo, on patients with stage III or IV periodontitis.
Status | Completed |
Enrollment | 56 |
Est. completion date | April 20, 2024 |
Est. primary completion date | January 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: • Clinically diagnosed with stage III or IV periodontitis according to the EFP/AAP 2017 criteria. Exclusion Criteria: - Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months. - Pregnancy. - Systemic diseases. |
Country | Name | City | State |
---|---|---|---|
Italy | AOU Policlinico G. Rodolico | Catania |
Lead Sponsor | Collaborator |
---|---|
University of Catania |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subgingival biofilm | Subgingival biofilm collected with sterile paper strips and analyzed by polimerase chain reaction | 2 weeks |
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