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NCT07079683 · ClinicalTrials.gov registry record · NA
RCT: Enzyme Blend Toothpaste on Dental Biofilm Plaque Accumulation
A NA study, sponsored by Novozymes A/S.
- Completed
- Registry status
- NA
- Development phase
- 132
- Enrollment target
NCT07079683 is a NA study that has completed, run by Novozymes A/S. The registered enrollment target is 132 participants.
The verdict
NCT07079683, a NA study, has completed, sponsored by Novozymes A/S.
- COMPLETED
- Registry status
- NA
- Development phase
- 132 participants
- Enrollment target
Study Summary
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 package
Interventions
- OTHER Toothpaste Product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2023-10-30 |
| Est. Completion | 2023-12-13 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07079683
The ClinicalTrials.gov registry entry for NCT07079683 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novozymes A/S, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Toothpaste Product is the first listed.
NCT07079683 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07079683 about?
NCT07079683 is a clinical study titled "RCT: Enzyme Blend Toothpaste on Dental Biofilm Plaque Accumulation". 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 ...
What is the current status of trial NCT07079683?
This trial is currently completed. It is a NA study. The enrollment target is 132 participants. The study started on 2023-10-30. Estimated completion is 2023-12-13.
What interventions are being tested in trial NCT07079683?
The interventions under investigation include: Toothpaste Product (OTHER).
Who is sponsoring clinical trial NCT07079683?
This trial is sponsored by Novozymes A/S, which has 5 total clinical trials registered on ClinicalTrials.gov.
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