Dental PlaqueNCT05579938
Effect of Enzymes on Dental Biofilm Accumulation
A study testing Enzyme-containing lozenge in people with Dental Plaque, run by Novozymes A/S at 1 site in United States.
Trial summary
Double-blind, placebo-controlled, cross-over study investigating dental biofilm accumulation after 4-days in 28 subjects randomised to receive: Sequence 1: 5 active enzyme-containing lozenges per day for 4-days followed by a 2-week washout period followed by 5 identical placebo lozenges per day for 4-days or Sequence… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Enzyme-containing lozenge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2022to 20 Nov 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy males and females 18-75 years of age.
- Able to read, sign and receive a copy of the signed informed consent form.
- Have at least 20 natural teeth with scorable facial and lingual surfaces. A scorable tooth is defined as having at least 2/3 of the natural tooth surface evaluable for the selected clinical measurements. The following will not be included in the scorable tooth count: third molars; teeth that are fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth; teeth exhibiting general cervical abrasion and/or enamel abrasion and calculus deposits which, in the opinion of the clinical examiner, would interfere with the assessments)..
- Willing to refrain from all oral hygiene 8-12 hours prior to Screening visit.
- Willing to refrain from use of chewing gum over the course of the 4-day intervention periods
- At the Screening Visit, subject presents with:
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- 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 12 hours plaque accumulation period.
- Willing and able to comply with scheduled visits, treatment plan and other study procedures.
- Willing to refrain from all oral hygiene (with the exception of lozenge consumption 5 times per day) for a 96-hour (4-day) period between Visits 2-4/Visits 5-7
- 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
- A subject with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the subject inappropriate for entry into this study.
- Subject self-reported as currently pregnant, or breastfeeding or subject intends to become pregnant through the duration of the study.
- Uncontrolled diabetes or hypertension.
- Health condition requirement for antibiotic premedication prior to dental procedures.
- Current history of antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 30 days of Screening visit.
- Subject is a smoker or user of smokeless tobacco, nicotine containing products (including chewing gum, patches, pouches or mints).
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- Subject has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- Presence of moderate or severe periodontal disease (Stage II, III or IV), or actively under treatment for periodontal disease.
- Presence of orthodontic appliances, peri/oral piercings, or removable partial dentures.
- 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 with high levels of extrinsic stain, calculus deposits or severely inflamed tissues which might interfere with dental plaque assessments.
- 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 Randomised, Double-blind Clinical Trial to Determine the Effect of a Lozenge Containing Enzymes on Dental Biofilm Accumulation in Healthy Adults Using a 4-day Plaque Regrowth Model.
Double-blind, placebo-controlled, cross-over study investigating dental biofilm accumulation after 4-days in 28 subjects randomised to receive:
Sequence 1: 5 active enzyme-containing lozenges per day for 4-days followed by a 2-week washout period followed by 5 identical placebo lozenges per day for 4-days or
Sequence 2: 5 placebo lozenges per day for 4-days followed by a 2-week washout period followed by 5 identical active enzyme lozenges per day for 4-days
Read the detailed description
28 healthy subjects (aged 18-75y) will be randomised to receive Sequence 1 or Sequence 2 in a double-blind, placebo-controlled cross-over study. Subjects will refrain from all mechanical oral hygiene over the course of each 4-day intervention period (e.g. no brushing, flossing, chewing gum) and will brush twice daily with a standard ADA accepted toothbrush and fluoride toothpaste during the 2-week washout period.
Sequence 1: 5 active enzyme-containing lozenges per day for 4-days followed by a 2-week washout period followed by 5 id entical placebo lozenges per day for 4-days or
Sequence 2: 5 placebo lozenges per day for 4-days followed by a 2-week washout period followed by 5 identical active enzyme lozenges per day for 4-days.
The primary outcome measure is 4-day biofilm accumulation as assessed by the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index score from Baseline (following dental prophy and score of 0) to Day 4 in the absence of oral mechanical hygiene (e.g. brushing, flossing).
The secondary outcome measure is 24-hour biofilm accumulation as assessed by the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index score from Baseline (following dental prophy and score of 0) to Day 1 (approximately 24-hours) in the absence of oral mechanical hygiene (e.g. brushing, flossing).
Exploratory measures include:
- Shift in S. mutans relative abundance and richness (number of species) from baseline to Day 4 based on Next Generation Sequencing (alpha/beta diversity and individual Amplicon Sequence Variants [ASV] measured by 16S sequencing)
- Shift in detected oral bacterial species of interest from baseline to Day 4, based on Next Generation Sequencing (alpha/beta diversity and individual Amplicon Sequence Variants [ASV] measured by 16S sequencing)
- Change in IL-1-beta, IL-6, IL-8 and TNF-alpha from baseline to Day 4, based on electrochemiluminescence assay
- Post-product use questionnaire (developed by sponsor) after 4 days of product use
- Conditions
- Dental Plaque
- Being tested
- Enzyme-containing lozenge, Placebo lozenge
- Keywords
- Enzymes, Dental biofilm, Dental plaque
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzyme-containing lozengeDietary supplement
A lozenge containing 3 active enzymes
Placebo lozengeDietary supplement
Identical placebo lozenge
| Study group | Role | What they receive |
|---|---|---|
| Verum Lozenges | Active comparator | Active enzyme-containing lozenges to be consumed 5 times per day for 4 days Receives: Dietary Supplement: Enzyme-containing lozenge |
| Identical Placebo Lozenges | Placebo comparator | Placebo lozenges to be consumed 5 times per day for 4 days Receives: Dietary Supplement: Placebo lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-day biofilm accumulation in the absence of oral mechanical hygiene
Biofilm accumulation is assessed by the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index (PLI)
Measured: 4-day biofilm accumulation from Baseline following dental prophylaxis (score of 0) to Day 4
Secondary outcomes (1)
24-hour biofilm accumulation in the absence of oral mechanical hygiene
Biofilm accumulation is assessed by the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index (PLI)
Measured: 24-hour biofilm accumulation from Baseline following dental prophylaxis (score of 0) to 24-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start19 Sep 2022
- Primary completion19 Oct 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novozymes A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery L Milleman, DDS, MPA, Principal investigator, Salus Research Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579938
- Sponsor's protocol ID
- 2022-NZ-03
- Status last verified
- Apr 2023
- First submitted
- 11 Oct 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind Clinical Trial to Determine the Effect of a Lozenge Containing Enzymes on Dental Biofilm Accumulation in Healthy Adults Using a 4-day Plaque Regrowth Model.
- ClinicalTrials.gov ID
- NCT05579938
- Acronym / sponsor ID
- 2022-NZ-03
- Conditions
- Dental Plaque
- Keywords
- Enzymes, Dental biofilm, Dental plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Novozymes A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 14 Oct 2022 (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.
Double-blind, placebo-controlled, cross-over study investigating dental biofilm accumulation after 4-days in 28 subjects randomised to receive:
Sequence 1: 5 active enzyme-containing lozenges per day for 4-days followed by a 2-week washout period followed by 5 identical placebo lozenges per day for 4-days or
Sequence 2: 5 placebo lozenges per day for 4-days followed by a 2-week washout period followed by 5 identical active enzyme lozenges per day for 4-days
Detailed description
28 healthy subjects (aged 18-75y) will be randomised to receive Sequence 1 or Sequence 2 in a double-blind, placebo-controlled cross-over study. Subjects will refrain from all mechanical oral hygiene over the course of each 4-day intervention period (e.g. no brushing, flossing, chewing gum) and will brush twice daily with a standard ADA accepted toothbrush and fluoride toothpaste during the 2-week washout period.
Sequence 1: 5 active enzyme-containing lozenges per day for 4-days followed by a 2-week washout period followed by 5 id entical placebo lozenges per day for 4-days or
Sequence 2: 5 placebo lozenges per day for 4-days followed by a 2-week washout period followed by 5 identical active enzyme lozenges per day for 4-days.
The primary outcome measure is 4-day biofilm accumulation as assessed by the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index score from Baseline (following dental prophy and score of 0) to Day 4 in the absence of oral mechanical hygiene (e.g. brushing, flossing).
The secondary outcome measure is 24-hour biofilm accumulation as assessed by the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index score from Baseline (following dental prophy and score of 0) to Day 1 (approximately 24-hours) in the absence of oral mechanical hygiene (e.g. brushing, flossing).
Exploratory measures include:
- Shift in S. mutans relative abundance and richness (number of species) from baseline to Day 4 based on Next Generation Sequencing (alpha/beta diversity and individual Amplicon Sequence Variants [ASV] measured by 16S sequencing)
- Shift in detected oral bacterial species of interest from baseline to Day 4, based on Next Generation Sequencing (alpha/beta diversity and individual Amplicon Sequence Variants [ASV] measured by 16S sequencing)
- Change in IL-1-beta, IL-6, IL-8 and TNF-alpha from baseline to Day 4, based on electrochemiluminescence assay
- Post-product use questionnaire (developed by sponsor) after 4 days of product use
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum Lozenges | Active comparator | Dietary Supplement: Enzyme-containing lozengeActive enzyme-containing lozenges to be consumed 5 times per day for 4 days |
| Identical Placebo Lozenges | Placebo comparator | Dietary Supplement: Placebo lozengePlacebo lozenges to be consumed 5 times per day for 4 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Generally healthy males and females 18-75 years of age.
- Able to read, sign and receive a copy of the signed informed consent form.
- Have at least 20 natural teeth with scorable facial and lingual surfaces. A scorable tooth is defined as having at least 2/3 of the natural tooth surface evaluable for the selected clinical measurements. The following will not be included in the scorable tooth count: third molars; teeth that are fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth; teeth exhibiting general cervical abrasion and/or enamel abrasion and calculus deposits which, in the opinion of the clinical examiner, would interfere with the assessments)..
- Willing to refrain from all oral hygiene 8-12 hours prior to Screening visit.
- Willing to refrain from use of chewing gum over the course of the 4-day intervention periods
Key exclusion criteria (12 listed)
- A subject with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the subject inappropriate for entry into this study.
- Subject self-reported as currently pregnant, or breastfeeding or subject intends to become pregnant through the duration of the study.
- Uncontrolled diabetes or hypertension.
- Health condition requirement for antibiotic premedication prior to dental procedures.
- Current history of antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 30 days of Screening visit.
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 |
|---|---|---|
| Enzyme-containing lozengeA lozenge containing 3 active enzymes | Dietary supplement | Verum Lozenges |
| Placebo lozengeIdentical placebo lozenge | Dietary supplement | Identical Placebo Lozenges |
Primary outcome
4-day biofilm accumulation in the absence of oral mechanical hygiene
Time frame: 4-day biofilm accumulation from Baseline following dental prophylaxis (score of 0) to Day 4
Biofilm accumulation is assessed by the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index (PLI)
1 secondary outcome
24-hour biofilm accumulation in the absence of oral mechanical hygiene
Time frame: 24-hour biofilm accumulation from Baseline following dental prophylaxis (score of 0) to 24-hours
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 12 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Jeffery L 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 Enzyme-containing lozenge in people with Dental Plaque, 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 10 inclusion and 12 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 12 Apr 2023. 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?
4-day biofilm accumulation in the absence of oral mechanical hygiene (time frame: 4-day biofilm accumulation from Baseline following dental prophylaxis (score of 0) to Day 4). 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 12 Apr 2023.