Toothpaste With Sodium Carbonate in Patients With Gingivitis

University of Catania

Status: Enrolling

Conditions: Periodontal Diseases; Gingivitis

Treatments: Drug: Toothpaste Product

Study type: Interventional

Funder types: Other

Identifiers

NCT06224699

149/22/PO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Test group

Experimental group

Description:

Use of toothpaste with sodium carbonate 67%

Treatment:

Drug: Toothpaste Product

Control

Placebo Comparator group

Description:

Use of toothpaste without sodium carbonate 67%

Treatment:

Drug: Toothpaste Product