Toothpaste with sodium carbonate for treating gingivitis
Clinical and Antimicrobial Effectiveness of a Toothpaste With Sodium Carbonate in Patients With Gingivitis
This study is testing if a toothpaste with sodium carbonate can help people with gingivitis reduce bacteria in their mouths better than regular fluoride toothpaste.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Catania Academic / other |
| Locations | 1 site (Catania) |
| Trial ID | NCT06224699 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two types of toothpaste: one containing 67% sodium carbonate and another fluoride toothpaste without bicarbonate, in managing gingivitis. It is designed as a double-blind randomized controlled trial with two parallel groups, assessing the clinical properties of these toothpastes over a 6-month follow-up period. The study aims to determine if sodium carbonate can effectively reduce bacterial biofilm in patients diagnosed with gingivitis.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals clinically diagnosed with gingivitis.
Not a fit: Patients who have undergone periodontal treatment or are on medications like antibiotics or NSAIDs in the last 6 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from gingivitis.
How similar studies have performed: While the specific use of sodium carbonate in toothpaste for gingivitis is novel, similar studies have shown promise in using alternative agents for managing oral biofilms.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Catania
- AOU Policlinico Catania — Catania, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.