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Clinical trial

Clinical and Antimicrobial Effectiveness of a Toothpaste With Sodium Carbonate in Patients With Gingivitis

ID
Name
149/22/PO
Description
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.
Trial arms
Trial start
2023-09-01
Estimated PCD
2024-03-01
Trial end
2024-03-01
Status
Recruiting
Treatment
Toothpaste Product
Use of toothpaste with or without sodium carbonate at 67%
Arms:
Control, Test group
Size
44
Primary endpoint
Gingival index (1-4)
6-months
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study was designed as a double-blind randomized controlled trial (RCT) with 2 parallel groups of individuals with gingivitis', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Sealed envelopes', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 44, 'type': 'ESTIMATED'}}
Updated at
2024-01-25

1 organization

1 product

2 indications

Organization
University of Catania
Product
Toothpaste
Indication
Gingivitis
Indication
Periodontal Diseases