Dental Biofilm AccumulationNCT07079683
RCT: Enzyme Blend Toothpaste on Dental Biofilm Plaque Accumulation
A study testing Toothpaste Product in people with Dental Biofilm Accumulation, run by Novozymes A/S at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Biofilm Accumulation
- What is being tested?
- Toothpaste Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2023to 13 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy males and females 18-65 years of age.
- Able to read, sign and receive a copy of the signed informed consent form.
- Willing and able to comply with scheduled visits, treatment plan and other study procedures.
- Subject is in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the subject's safety, wellbeing or the outcome of the study.
- At the Screening Visit (Visit 1):
- Have at least 20 natural teeth with scorable facial and lingual surfaces. (A scorable surface is defined as having 2/3rds of the natural tooth surface gradable for the selected clinical indices. The following should not be included in the evaluable surface count- third molars; fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth; surfaces with calculus deposits which, in the opinion of the clinical examiner, would interfere with the baseline assessments of the selected clinical indices.)
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- Subject with generalized mild-moderate plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by visual examinations.
- At Screening Visit (Visit 1):
- A gingival index score of ≥ 1.0, according to the Löe-Silness Gingival Index.
- A plaque index score ≥ 1.95 according to the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index, following 8 to 16 hours plaque accumulation period.
- Willing to refrain from all oral hygiene 8-16 hours prior to each study visit, refrain from eating within 4 hours prior to each study visit and discontinue drinking 30 minutes prior to each study visit.
- Willing to refrain from using chewing gum, breath mints and lozenges for the duration of the study.
- Willing to refrain from the use of chemotherapeutic antiplaque/antigingivitis products containing antibacterial agents such as, but not limited to, amine fluoride, chlorhexidine, stannous fluoride, essential oils, cetylpyridinium chloride, etc. and other oral hygiene products during the study.
Who cannot join
- Subjects presenting with any of the following will not be included in the study:
- Have any medical condition that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
- History of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
- A subject who is pregnant or intending to become pregnant over the duration of the study (self-reported).
- A subject who is breastfeeding.
- Self-reported serious medical conditions.
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- Uncontrolled diabetes or hypertension.
- Antibiotic or anti-inflammatory medication within 30 days of screening visit. 8. Smokers or users of other nicotine products.
- 9. Any health condition that requires prophylactic antibiotics prior to any dental procedure to prevent infective endocarditis.
- 10. Daily use of steroidal or non-steroidal anti-inflammatory drugs. 11. Have had antibiotic, anti-inflammatory, or chemotherapeutic antiplaque/antigingivitis therapy within 30 days of screening exams.
- 12. Unwilling to discontinue use of other oral hygiene products (e.g., antiplaque-antigingivitis mouthrinses or dentifrices, power toothbrushes, oral irrigators/water flossers) for the duration of the study.
- 13. Clinically visible active caries lesions and/or periodontitis. 14. Orthodontic appliances, including retainers, peri/oral piercings, or removable partial dentures.
- 15. Exhibits ≥ 30% of teeth with stage II - IV periodontitis, according to the American Academy of Periodontology revised classification system for periodontal and peri-implant diseases and conditions,8 at screening and/or baseline visit, or being actively treated for periodontal disease, and have more than three teeth with periodontal pockets depths measuring more than 5 mm. 16. Have significant intra-oral soft tissue lesions due to pathology or trauma based on a visual examination.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Toothpaste Product
- Keywords
- RCT, Toothpaste, Enzymes, Biofilm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste ProductOther
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.
Toothpaste ProductOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo toothpaste without enzymes | Placebo comparator | Placebo toothpaste without 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. Receives: Other: Toothpaste Product |
| BioFresh Clean toothpaste containing a blend of alpha-amylase and gluco-amylase enzymes | Experimental | 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. Receives: Other: Toothpaste Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole mouth dental plaque accumulation at Day 28.
Change in mean whole Mouth (WM) dental plaque accumulation assessed using the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index (PLI) with a score range from 0 to 5. A score of 0 means no plaque, while higher scores indicate increasing amounts of plaque.
Measured: Day 28
Secondary outcomes (14)
Whole mouth dental plaque accumulation Day 1
Mean WM dental plaque accumulation is assessed using PLI with a score range from 0 to 5. A score of 0 means no plaque, while higher scores indicate increasing amounts of plaque.
Measured: Day 1
Whole mouth dental plaque accumulation Day 14
Mean WM dental plaque accumulation is assessed using PLI with a score range from 0 to 5. A score of 0 means no plaque, while higher scores indicate increasing amounts of plaque.
Measured: Day 14
Gumline Plaque Severity Index (PSI) scores Day 1
Gumline Plaque Severity Index (PSI) scores calculated from PLI scores by dividing the total number of tooth surface sites receiving scores of 3, 4 or 5 by the total number of tooth surface sites scored in the mouth. The scale is ranging from 0 to 5, with higher scores indicating a worse condition.
Measured: Day 1
Gumline Plaque Severity Index (PSI) scores Day 14
Gumline PSI scores calculated from PLI scores by dividing the total number of tooth surface sites receiving scores of 3, 4 or 5 by the total number of tooth surface sites scored in the mouth. The scale is ranging from 0 to 5, with higher scores indicating a worse condition.
Measured: Day 14
Gumline Plaque Severity Index (PSI) scores Day 28
Gumline PSI scores calculated from PLI scores by dividing the total number of tooth surface sites receiving scores of 3, 4 or 5 by the total number of tooth surface sites scored in the mouth. The scale is ranging from 0 to 5, with higher scores indicating a worse condition.
Measured: Day 28
Proximal Plaque Severity Index (PSI) scores at Day 1
Proximal Plaque Severity Index (PSI) scores calculated from PLI scores by dividing the total number of tooth surface sites receiving scores of 3, 4 or 5 by the total number of tooth surface sites scored in the mouth. The scale is ranging from 0 to 5, with higher scores indicating a worse condition.
Measured: Day 1
Proximal Plaque Severity Index (PSI) scores Day 14
Proximal PSI scores calculated from PLI scores by dividing the total number of tooth surface sites receiving scores of 3, 4 or 5 by the total number of tooth surface sites scored in the mouth. The scale is ranging from 0 to 5, with higher scores indicating a worse condition.
Measured: Day 14
Proximal Plaque Severity Index (PSI) scores Day 28
Proximal PSI scores calculated from PLI scores by dividing the total number of tooth surface sites receiving scores of 3, 4 or 5 by the total number of tooth surface sites scored in the mouth. The scale is ranging from 0 to 5, with higher scores indicating a worse condition.
Measured: Day 28
Whole mouth Gingival Index (GI) scores Day 14
Whole mouth Gingivitis Index score according to according to the Löe-Silness Gingival Index (GI) scoring it on a scale from 0 to 3, with 0 representing a healthy gingiva and 3 indicating severe inflammation.
Measured: Day 14
Whole mouth Gingival Index (GI) scores Day 28
Whole mouth Gingivitis Index score according to according to the Löe-Silness Gingival Index (GI) scoring it on a scale from 0 to 3, with 0 representing a healthy gingiva and 3 indicating severe inflammation.
Measured: Day 28
Gumline Gingivitis Severity Index score Day 14
Gumline Gingivitis Severity Index score according to the Löe-Silness Gingival Index, the proportion of tooth sites receiving the high-level GI scores of 2 and 3 at baseline will be included in the calculation to provide the Gingivitis Severity Index measures.19 Site-wise scores for whole mouth, gumline and proximal sites, will be calculated by counting the scores for the sites with baseline GI = 2 and 3 and dividing by the total number of sites assessed. The score is ranging from 0 to 3, with higher scores reflect more advanced inflammation.
Measured: Day 14
Gumline Gingivitis Severity Index score Day 28
Gumline Gingivitis Severity Index score according to the Löe-Silness Gingival Index, the proportion of tooth sites receiving the high-level GI scores of 2 and 3 at baseline will be included in the calculation to provide the Gingivitis Severity Index measures.19 Site-wise scores for whole mouth, gumline and proximal sites, will be calculated by counting the scores for the sites with baseline GI = 2 and 3 and dividing by the total number of sites assessed. The score is ranging from 0 to 3, with higher scores reflect more advanced inflammation.
Measured: Day 28
Proximal Gingivitis Severity Index score Day 14
Proximal Gingivitis Severity Index score according to the Löe-Silness Gingival Index, the proportion of tooth sites receiving the high-level GI scores of 2 and 3 at baseline will be included in the calculation to provide the Gingivitis Severity Index measures.19 Site-wise scores for whole mouth, gumline and proximal sites, will be calculated by counting the scores for the sites with baseline GI = 2 and 3 and dividing by the total number of sites assessed. The score is ranging from 0 to 3, with higher scores reflect more advanced inflammation.
Measured: Day 14
Proximal Gingivitis Severity Index scores Day 28
Proximal Gingivitis Severity Index score according to the Löe-Silness Gingival Index, the proportion of tooth sites receiving the high-level GI scores of 2 and 3 at baseline will be included in the calculation to provide the Gingivitis Severity Index measures.19 Site-wise scores for whole mouth, gumline and proximal sites, will be calculated by counting the scores for the sites with baseline GI = 2 and 3 and dividing by the total number of sites assessed. The score is ranging from 0 to 3, with higher scores reflect more advanced inflammation.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start30 Oct 2023
- Primary completion7 Dec 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Biofilm AccumulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a single center, placebo controlled, double-blind, randomized, two-treatment arm, parallel design, clinical study. Study subjects will be aged 18 years or older, non-smokers, in good general health with generalized mild to moderate plaque-induced gingivitis and ≥ 20 natural teeth. The use of a Washout period prior to Baseline will be included in this design so that subjects avoid use of antimicrobial mouth rinses, dentifrices or other dental products that might affect a subject's plaque or gingivitis status. Subjects will be asked to use a marketed fluoride-free toothpaste and soft bristle toothbrush as their only oral hygiene regimen. A minimum of 7 days lead-in period is appropriate to allow subjects to comply with study and lifestyle restrictions prior to Baseline Visit. Subjects must meet all study criteria at both the Screening and Baseline visits to be eligible for participation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novozymes A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Milleman, DDS, MPA, Principal investigator, Salus Research Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079683
- Sponsor's protocol ID
- NZ-2022-04
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07079683
- Acronym / sponsor ID
- NZ-2022-04
- Conditions
- Dental Biofilm Accumulation
- Keywords
- RCT, Toothpaste, Enzymes, Biofilm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Novozymes A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a single center, placebo controlled, double-blind, randomized, two-treatment arm, parallel design, clinical study. Study subjects will be aged 18 years or older, non-smokers, in good general health with generalized mild to moderate plaque-induced gingivitis and ≥ 20 natural teeth. The use of a Washout period prior to Baseline will be included in this design so that subjects avoid use of antimicrobial mouth rinses, dentifrices or other dental products that might affect a subject's plaque or gingivitis status. Subjects will be asked to use a marketed fluoride-free toothpaste and soft bristle toothbrush as their only oral hygiene regimen. A minimum of 7 days lead-in period is appropriate to allow subjects to comply with study and lifestyle restrictions prior to Baseline Visit. Subjects must meet all study criteria at both the Screening and Baseline visits to be eligible for participation.
| Arm | Type | Receives |
|---|---|---|
| Placebo toothpaste without enzymes | Placebo comparator | Other: Toothpaste ProductPlacebo toothpaste without 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. |
| BioFresh Clean toothpaste containing a blend of alpha-amylase and gluco-amylase enzymes | Experimental | Other: Toothpaste ProductBioFresh 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Generally healthy males and females 18-65 years of age.
- Able to read, sign and receive a copy of the signed informed consent form.
- Willing and able to comply with scheduled visits, treatment plan and other study procedures.
- Subject is in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the subject's safety, wellbeing or the outcome of the study.
- At the Screening Visit (Visit 1):
Key exclusion criteria (13 listed)
- Have any medical condition that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
- History of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
- A subject who is pregnant or intending to become pregnant over the duration of the study (self-reported).
- A subject who is breastfeeding.
- Self-reported serious medical conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toothpaste ProductBioFresh 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 | BioFresh Clean toothpaste containing a blend of alpha-amylase and gluco-amylase enzymes |
| Toothpaste ProductPlacebo 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. | Other | Placebo toothpaste without enzymes |
Primary outcome
Whole mouth dental plaque accumulation at Day 28.
Time frame: Day 28
Change in mean whole Mouth (WM) dental plaque accumulation assessed using the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index (PLI) with a score range from 0 to 5. A score of 0 means no plaque, while higher scores indicate increasing amounts of plaque.
14 secondary outcomes
Whole mouth dental plaque accumulation Day 1
Time frame: Day 1
Whole mouth dental plaque accumulation Day 14
Time frame: Day 14
Gumline Plaque Severity Index (PSI) scores Day 1
Time frame: Day 1
Gumline Plaque Severity Index (PSI) scores Day 14
Time frame: Day 14
Gumline Plaque Severity Index (PSI) scores Day 28
Time frame: Day 28
Proximal Plaque Severity Index (PSI) scores at Day 1
Time frame: Day 1
Proximal Plaque Severity Index (PSI) scores Day 14
Time frame: Day 14
Proximal Plaque Severity Index (PSI) scores Day 28
Time frame: Day 28
Whole mouth Gingival Index (GI) scores Day 14
Time frame: Day 14
Whole mouth Gingival Index (GI) scores Day 28
Time frame: Day 28
Gumline Gingivitis Severity Index score Day 14
Time frame: Day 14
Gumline Gingivitis Severity Index score Day 28
Time frame: Day 28
Proximal Gingivitis Severity Index score Day 14
Time frame: Day 14
Proximal Gingivitis Severity Index scores Day 28
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Milleman, DDS, MPA principal investigator
Salus Research Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothpaste Product in people with Dental Biofilm Accumulation, run by Novozymes A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole mouth dental plaque accumulation at Day 28. (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.