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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Non-surgical periodontal treatment

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Catania, Italy, 95124
    • AOU Policlinico G. Rodolico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chlorhexidine 0,12% + Sodium DNA mouthwash; Patients are treated with a mouthwash containing Chlorhexidine 0,12% + Sodium DNA	Procedure: Non-surgical periodontal treatment; Subgingival biofilm ultrasonic debridement
Active Comparator: Chlorhexidine 0,20% mouthwash; Patients are treated with a mouthwash containing Chlorhexidine 0,20%	Procedure: Non-surgical periodontal treatment; Subgingival biofilm ultrasonic debridement
Placebo Comparator: Placebo mouthwash; Patients are treated with a placebo mouthwash	Procedure: Non-surgical periodontal treatment; Subgingival biofilm ultrasonic debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subgingival biofilm	Subgingival biofilm collected with sterile paper strips and analyzed by polimerase chain reaction	2 weeks

Collaborators and Investigators

• Sponsor: University of Catania

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2020
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): April 20, 2024

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: 121-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No