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Toothpaste With Sodium Carbonate in Patients With Gingivitis

Not Applicable
Recruiting
Conditions
Gingivitis
Periodontal Diseases
Interventions
Drug: Toothpaste Product
Registration Number
NCT06224699
Lead Sponsor
University of Catania
Brief 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.

Detailed 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 & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
44
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Test groupToothpaste ProductUse of toothpaste with sodium carbonate 67%
ControlToothpaste ProductUse of toothpaste without sodium carbonate 67%
Primary Outcome Measures
NameTimeMethod
Gingival index (1-4)6-months

Gingival index reduction

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

AOU Policlinico Catania

🇮🇹

Catania, Italy

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