Clinical and Antimicrobial Effectiveness of a Toothpaste With Sodium Carbonate in Patients With Gingivitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Catania
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Gingival index (1-4)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Sealed envelopes
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Test group
Use of toothpaste with sodium carbonate 67%
Intervention: Toothpaste Product (Drug)
Control
Use of toothpaste without sodium carbonate 67%
Intervention: Toothpaste Product (Drug)
Outcomes
Primary Outcomes
Gingival index (1-4)
Time Frame: 6-months
Gingival index reduction
Secondary Outcomes
No secondary outcomes reported
Investigators
Gaetano Isola
Associate Professor
University of Catania