RCT: Enzyme Blend Toothpaste on Dental Biofilm Plaque Accumulation

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 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

Conditions

• Dental Biofilm Accumulation

Interventions

OTHER

Toothpaste Product

BioFresh toothpaste containing a blend of alpha-amylase and gluco-amylase enzymes to be used twice a day, morning and evening, (one minute) at a dose of approximately 1.5 g/toothbrushing (full ribbon of toothpaste) for the 28-day study duration.

OTHER

Toothpaste Product

Placebo toothpaste containing no enzymes to be used twice a day, morning and evening, (one minute) at a dose of approximately 1.5 g/toothbrushing (full ribbon of toothpaste) for the 28-day study duration.

Sponsors & Collaborators

• Novozymes A/S

  lead INDUSTRY

Principal Investigators

• Jeffrey Milleman, DDS, MPA · Salus Research Inc

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-10-30

Primary Completion

2023-12-07

Completion

2023-12-13

Countries

• United States

Study Locations