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

University of Catania

Status: Completed

Conditions: Periodontitis

Treatments: Procedure: Non-surgical periodontal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06028867

121-29

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 3 patient groups, including a placebo group

Chlorhexidine 0,12% + Sodium DNA mouthwash

Experimental group

Description:

Patients are treated with a mouthwash containing Chlorhexidine 0,12% + Sodium DNA

Treatment:

Procedure: Non-surgical periodontal treatment

Chlorhexidine 0,20% mouthwash

Active Comparator group

Description:

Patients are treated with a mouthwash containing Chlorhexidine 0,20%

Treatment:

Procedure: Non-surgical periodontal treatment

Placebo mouthwash

Placebo Comparator group

Description:

Patients are treated with a placebo mouthwash

Treatment:

Procedure: Non-surgical periodontal treatment