RCT: Enzyme Blend Toothpaste on Dental Biofilm Plaque Accumulation
Public ClinicalTrials.gov record NCT07079683. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Clinical Trial to Determine the Effect of a Toothpaste Containing Enzymes Blend of Alpha-Amylase and Gluco-Amylase on Dental Biofilm Plaque Accumulation in Healthy Adults Over a 28-Day Period of Product Use
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The aim of the study is to investigate whether brushing twice a day with a toothpaste (Biofresh Clean) containing a blend of alpha-amylase and gluco-amylase improves oral health outcomes over a 14-day period. The primary objective is to evaluate if the enzyme-containing toothpaste has an effect on dental plaque accumulation compared to placebo following 28 days of use. The secondary objectives are to: * Evaluate if the enzyme-containing toothpaste has an effect on dental plaque accumulation compared to placebo at Days 1 and 14 * Evaluate if the enzyme-containing toothpaste has an effect on gumline and proximal plaque severity compared to placebo at Days 1, 14 and 28 * Evaluate if the enzyme-containing toothpaste has an effect on whole mouth Gingivitis as well as gumline and proximal Gingivitis severity compared to placebo at Days 14 and 28 The exploratory variables are to investigate if the enzyme-containing toothpaste results in: * Shift in detected oral bacterial species of interest at Screening and Baseline to Days 14 and 28, based on microbial DNA-extraction and microbial whole genome sequencing compared to placebo. * Shift in immune markers (IL-1β, , IL-8 and MIF) at Screening and Baseline to Days 14 and 28, based on electrochemiluminescence assay compared to placebo. * Difference in performance attributes compared to placebo based on End of Study Post-product use questionnaire after 28 days of product use. The safety objective is to investigate safety and tolerability of brushing twice daily based on treatment emergent adverse events. Target Population Randomized subjects are generally healthy males and females (18-65y) with at least 20 natural teeth, A gingival index score of ≥ 1.0, according to the Löe-Silness Gingival Index at baseline and a plaque index score ≥ 1.95 according to the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index.. Researchers will compare Biofresh Clean Toothpaste to an identically packaged and labelled placebo to see if Biofresh Clean Toothpaste reduces dental plaque accumulation and Gingivitis. Participants will: * Brush teeth for one minute twice per day (morning and evening) with either 1.5g of Biofresh Clean toothpaste or identical placebo toothpaste over 14-days. * Visit the dental clinic on 5 occasions: 1. Screening visit to assess eligibility; 2. Baseline visit; 3. Day 1 Visit; 4. Day 14 visit; 5. Day 28 visit
Study identification
- NCT ID
- NCT07079683
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 132 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 29, 2023
- Primary completion
- Dec 6, 2023
- Completion
- Dec 12, 2023
- Last update posted
- Aug 7, 2025
2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Salus Research Inc | Fort Wayne | Indiana | 46825 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07079683, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 7, 2025 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07079683 live on ClinicalTrials.gov.