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

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Procedure: Non-surgical periodontal treatment

• Registration Number: NCT06028867
• Lead Sponsor: University of Catania

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-01-24
• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-08-31
• Study First Posted: 2023-09-08
• Primary Completion: 2024-01-30
• Study Completion: 2024-04-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine 0,20% mouthwash	Non-surgical periodontal treatment	Patients are treated with a mouthwash containing Chlorhexidine 0,20%
Placebo mouthwash	Non-surgical periodontal treatment	Patients are treated with a placebo mouthwash
Chlorhexidine 0,12% + Sodium DNA mouthwash	Non-surgical periodontal treatment	Patients are treated with a mouthwash containing Chlorhexidine 0,12% + Sodium DNA

Primary Outcome Measures

Name	Time	Method
Subgingival biofilm	2 weeks	Subgingival biofilm collected with sterile paper strips and analyzed by polimerase chain reaction

Trial Locations

Locations (1)

AOU Policlinico G. Rodolico; 🇮🇹 Catania, Italy