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

NCT ID: NCT06028867

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-24

Study Completion Date

2024-04-20

Brief Summary

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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

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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.

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Sealed envelopes

Study Groups

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Chlorhexidine 0,12% + Sodium DNA mouthwash

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

Group Type EXPERIMENTAL

Non-surgical periodontal treatment

Intervention Type PROCEDURE

Subgingival biofilm ultrasonic debridement

Chlorhexidine 0,20% mouthwash

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

Group Type ACTIVE_COMPARATOR

Non-surgical periodontal treatment

Intervention Type PROCEDURE

Subgingival biofilm ultrasonic debridement

Placebo mouthwash

Patients are treated with a placebo mouthwash

Group Type PLACEBO_COMPARATOR

Non-surgical periodontal treatment

Intervention Type PROCEDURE

Subgingival biofilm ultrasonic debridement

Interventions

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Non-surgical periodontal treatment

Subgingival biofilm ultrasonic debridement

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Isola

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AOU Policlinico G. Rodolico

Catania, , Italy

Site Status

Countries

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Italy

Other Identifiers

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121-29

Identifier Type: -

Identifier Source: org_study_id

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