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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

Primary Purpose

Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Non-surgical periodontal treatment
Sponsored by
University of Catania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • AOU Policlinico G. RodolicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Chlorhexidine 0,12% + Sodium DNA mouthwash

Chlorhexidine 0,20% mouthwash

Placebo mouthwash

Arm Description

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

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

Patients are treated with a placebo mouthwash

Outcomes

Primary Outcome Measures

Subgingival biofilm
Subgingival biofilm collected with sterile paper strips and analyzed by polimerase chain reaction

Secondary Outcome Measures

Full Information

First Posted
August 31, 2023
Last Updated
August 31, 2023
Sponsor
University of Catania
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1. Study Identification

Unique Protocol Identification Number
NCT06028867
Brief Title
Validation of the Clinical and Antimicrobial Effectiveness of a Clorexidine and Sodium DNA Based Mouthwash in Patients With Stage III and IV Periodontitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2020 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.
Masking
ParticipantCare Provider
Masking Description
Sealed envelopes
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine 0,12% + Sodium DNA mouthwash
Arm Type
Experimental
Arm Description
Patients are treated with a mouthwash containing Chlorhexidine 0,12% + Sodium DNA
Arm Title
Chlorhexidine 0,20% mouthwash
Arm Type
Active Comparator
Arm Description
Patients are treated with a mouthwash containing Chlorhexidine 0,20%
Arm Title
Placebo mouthwash
Arm Type
Placebo Comparator
Arm Description
Patients are treated with a placebo mouthwash
Intervention Type
Procedure
Intervention Name(s)
Non-surgical periodontal treatment
Intervention Description
Subgingival biofilm ultrasonic debridement
Primary Outcome Measure Information:
Title
Subgingival biofilm
Description
Subgingival biofilm collected with sterile paper strips and analyzed by polimerase chain reaction
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaetano Prof. Isola, PhD
Phone
+39-095-378-2453
Email
gaetano.isola@unict.it
Facility Information:
Facility Name
AOU Policlinico G. Rodolico
City
Catania
ZIP/Postal Code
95124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola, DDS
Phone
+3909537800
Email
gaetano.isola@unict.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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