Gingivitis, Periodontal Diseases
Conditions
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.
Interventions
Use of toothpaste with or without sodium carbonate at 67%
Sponsors
University of Catania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Sealed envelopes
Intervention model description
The study was designed as a double-blind randomized controlled trial (RCT) with 2 parallel groups of individuals with gingivitis
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival index (1-4) | 6-months | Gingival index reduction |
Countries
Italy
Outcome results
None listed