NCT06082869

Evaluation and Comparison of a Novel Dentrifice Formulation on Plaque Removal

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Protegera, Inc. · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

Summary

To evaluate and compare plaque removal efficacy and safety of a novel dentifrice formulation immediately after the first supervised use and following one week of twice, daily use at home.

Detailed description

Study participants brushed their teeth for one minute, two times daily, for seven days. Participants who met study entry criteria were randomized to either the test (Protegera™) or control (Crest™ Cavity Protection) toothpaste, and each were given the same straight, soft bristled toothbrush to use throughout the study. On Day 1, participants were given an oral exam, and a pre-brushing plaque score was recorded. Participants then brushed their teeth for one minute under supervision, and a post-brushing plaque score was recorded. On Day 7, participants were given an oral exam, and a pre-brushing plaque score was recorded. Participants then brushed their teeth for one minute under supervision, and a post-brushing plaque score was recorded.

Conditions

• Dental Plaque

Interventions

Type	Name	Description
DRUG	Protegera™ toothpaste (NaF)	Plaque Reduction
DRUG	Crest™ Cavity Protection toothpaste (NaF)	Plaque Reduction

Timeline

• Start date: 2023-01-30
• Primary completion: 2023-02-23
• Completion: 2023-02-23
• First posted: 2023-10-13
• Last updated: 2023-10-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study