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NCT06028867 Clinical Trial

Validation of the Clinical and Antimicrobial Effectiveness of a Clorexidine and Sodium DNA Based Mouthwash in Patients With Stage III and IV Periodontitis

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

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date May 2024
Source University of Catania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

Sodium DNA has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. The aim of this RCTstudy 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. The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Non-surgical periodontal treatment
Subgingival biofilm ultrasonic debridement

Locations
Country Name City State
Italy AOU Policlinico G. Rodolico Catania

Sponsors (1)
Lead Sponsor Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome
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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