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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06028867

Enrollment

Registered

2023-09-08

Start date

2020-01-24

Completion date

2024-04-20

Last updated

2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

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 0.2% + Sodium DNA and Chlorhexidine 0.2% 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 0.2% + Sodium DNA and Chlorhexidine 0.20% for 2 weeks of therapy, 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.

Interventions

PROCEDURENon-surgical periodontal treatment

Subgingival biofilm ultrasonic debridement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Masking description

Sealed envelopes

Intervention model description

The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Subgingival biofilm	6 months	Subgingival biofilm collected with sterile paper strips and analyzed by polimerase chain reaction
FMBS	6 months	Full mouth bleeding score

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026