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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06028867
Recruitment Status : Completed
First Posted : September 8, 2023
Last Update Posted : May 8, 2024
Sponsor:
Information provided by (Responsible Party):
Gaetano Isola, University of Catania

Study Description
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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.

Condition or disease Intervention/treatment Phase
Periodontitis Procedure: Non-surgical periodontal treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.
Masking: Double (Participant, Care Provider)
Masking Description: Sealed envelopes
Primary Purpose: Treatment
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
Actual Study Start Date : January 24, 2020
Actual Primary Completion Date : January 30, 2024
Actual Study Completion Date : April 20, 2024
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Subgingival biofilm [ Time Frame: 2 weeks ]
    Subgingival biofilm collected with sterile paper strips and analyzed by polimerase chain reaction


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06028867


Locations
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Italy
AOU Policlinico G. Rodolico
Catania, Italy, 95124
Sponsors and Collaborators
University of Catania
More Information
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Responsible Party: Gaetano Isola, Researcher, University of Catania
ClinicalTrials.gov Identifier: NCT06028867    
Other Study ID Numbers: 121-29
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: May 8, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases