Toothpaste With Sodium Carbonate in Patients With Gingivitis

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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