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NCT06224699 Clinical Trial

Toothpaste With Sodium Carbonate in Patients With Gingivitis

Periodontal Diseases Clinical Trial

Official title:
Clinical and Antimicrobial Effectiveness of a Toothpaste With Sodium Carbonate in Patients With Gingivitis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06224699
Other study ID # 149/22/PO
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date March 1, 2024

Study information
Verified date January 2024
Source University of Catania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sodium carbonate has several properties that may be beneficial in the management of bacterial biofilm in gingivitis patients. The aim of this RCT study is to clinically evaluate the clinical properties of two toothpaste containing Sodium carbonate 67% and fluoride toothpaste that contains no bicarbonate on patients with gengivitis.

Description:

Sodium carbonate has several properties that may be beneficial in the management of bacterial biofilm in both gingivitis and periodontitis patients. The aim of this RCT study is to clinically evaluate the clinical properties of two toothpaste containing sodium carbonate at 67% or no sodium carbonate at 67% at 6-month follow-up in patients with gingivits. The study was designed as a double-blind randomized controlled trial (RCT) with 2 parallel groups of individuals.

Recruitment information / eligibility
Status Recruiting
Enrollment 44
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Clinically diagnosed with gingivitis according to the EFP/AAP 2017 criteria. Exclusion Criteria: - Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months. - Pregnancy. - Systemic diseases.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Toothpaste Product
Use of toothpaste with or without sodium carbonate at 67%

Locations
Country Name City State
Italy AOU Policlinico Catania Catania

Sponsors (1)
Lead Sponsor Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gingival index (1-4) Gingival index reduction 6-months
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