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

Study Overview
=================
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.

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

Conditions
-----------------
Periodontitis

Intervention / Treatment
-----------------
* Procedure: Non-surgical periodontal treatment


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.
Masking: Double


Arms and Interventions

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

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 |