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

Sponsor

University of Catania (Other)

Overall Status

Recruiting

CT.gov ID

NCT06028867

Collaborator

(none)

Enrollment

Location

Arms

48.3

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis	Procedure: Non-surgical periodontal treatment	N/A

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

Study Type:

Interventional

Anticipated 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.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 :

Jan 24, 2020

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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

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

Primary Outcome Measures

Subgingival biofilm [2 weeks]
Subgingival biofilm collected with sterile paper strips and analyzed by polimerase chain reaction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Policlinico G. Rodolico	Catania		Italy	95124

Sponsors and Collaborators

University of Catania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gaetano Isola, Researcher, University of Catania

ClinicalTrials.gov Identifier:

NCT06028867

Other Study ID Numbers:

121-29

First Posted:

Sep 8, 2023

Last Update Posted:

Sep 8, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Periodontitis

Study Results

No Results Posted as of Sep 8, 2023