Dental PlaqueNCT05082103
Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals
A study testing Enzyme lozenge 1 and Enzyme lozenge 2 in people with Dental Plaque, run by Novozymes A/S at 1 site in Denmark.
Trial summary
The purpose of the study is to assess the effect of enzyme containing lozenges on dental plaque accumulation in healthy adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Enzyme lozenge 1 and Enzyme lozenge 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2021to 31 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy males and females ≥18 years of age.
- Able to read, sign and receive a copy of the signed informed consent form.
- Have at least 20 natural teeth.
Who cannot join
- Clinically visible active caries lesions and/or periodontitis.
- Significant oral soft tissue pathology based on a visual examination.
- 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.
- History of allergies to ingredients in the test product.
- Self-reported as pregnant or nursing.
- Self-reported serious medical conditions.
Show all 9Show fewer
- Antibiotic or anti-inflammatory medication within 30 days of screening visit.
- Orthodontic appliances, including retainers, peri/oral piercings, or removable partial dentures.
- Acute sinusitis or severe oral-pharyngeal infections.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Department of Dentistry and Oral Health
Aarhus, 8000
About this study
Official title: Effect of Enzyme-containing Lozenges on Dental Biofilm Accumulation in Healthy Individuals: A Randomized Placebo-controlled Clinical Trial
The purpose of the study is to assess the effect of enzyme containing lozenges on dental plaque accumulation in healthy adults.
Read the detailed description
The purpose of the study is to examine the clinical effects of lozenges containing three extracellular matrix-degrading enzymes on dental plaque accumulation and removal, prevention of gingivitis, and oral microbiome composition after professional tooth cleaning, as compared to a placebo lozenge without enzymes. Two different concentrations of the enzymes will be tested, to investigate a potential dose-dependent effect of the enzymes. Furthermore, safety of the enzyme lozenge will be assessed by clinical evaluation of the oral mucosa. The null hypothesis is that treatment with enzyme-containing lozenges does not affect plaque accumulation as compared to a placebo control.
- Conditions
- Dental Plaque
- Being tested
- Enzyme lozenge 1, Enzyme lozenge 2, Placebo lozenge
- Keywords
- Enzymes, Dental plaque, Gingivitis, Oral microbiome
- Medical subject headings
- Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzyme lozenge 1Other
Participants are instructed to take one enzyme containing lozenge three times daily, at least 30 min after a meal, for 14 days. No normal oral hygiene procedures are allowed during the intervention period.
Enzyme lozenge 2Other
Participants are instructed to take one lozenge with 3x higher enzyme concentration three times daily, at least 30 min after a meal, for 14 days. No normal oral hygiene procedures are allowed during the intervention period.
Placebo lozengeOther
Participants are instructed to take one placebo lozenge three times daily, at least 30 min after a meal, for 14 days. No normal oral hygiene procedures are allowed during the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Enzyme lozenge 1 | Active comparator | The lozenge contains three plaque extracellular matrix degrading enzymes Receives: Other: Enzyme lozenge 1 |
| Enzyme lozenge 2 | Active comparator | The concentration of the three enzymes in the "Enzyme lozenge 2" is threefold the enzyme concentration than in the "Enzyme lozenge 1" Receives: Other: Enzyme lozenge 2 |
| Placebo lozenge | Placebo comparator | The placebo lozenge contains the same ingredients except for the enzymes and has an identical taste, color and texture Receives: Other: Placebo lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque amount
Dental plaque accumulation after 1-day use of either a test or placebo investigational lozenge assessed by the Turesky modified Quingly-Hein Plaque Index (QHPI) (score 0-5, 0 being no plaque, 5 being entire tooth covered with plaque)
Measured: Change in QHPI score from baseline to 24 hours' follow-up
Secondary outcomes (5)
Plaque amount
Dental plaque accumulation after 7 and 14 days assessed by the Turesky modified Quingly-Hein Plaque Index (QHPI) (score 0-5, 0 being no plaque, 5 being entire tooth covered with plaque)
Measured: Change in QHPI score from baseline to Day 7 follow-up and from baseline to Day 14 follow-up
Gingivitis
Development of gingivitis after 14 days assessed by the Gingival Index of Löe and Silness (GI) (score 0-3, 0 being no gingivitis, 3 being excessive gingivitis)
Measured: Change in GI from baseline to Day 14 follow-up
Plaque removal
Plaque removal by mechanical treatment with a water-/airpik. The technique will be applied professionally at the clinical site by co-investigator.
Measured: Day 14 visit
Oral microbiome
Oral microbiome composition
Measured: Change in microbiome composition from baseline to Day 14 follow-up
Plaque fluorescence intensity measurement
Dental plaque accumulation assessed by fluorescence intensity measurements, to provide information on the individual level of plaque formation. Soft biofilm on the teeth is calculated using an appropriate software program, compatible with the device used.
Measured: Change in intensity measurement from baseline to Day 7 follow-up and Day 14 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start15 Sep 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Why it stopped: The study was terminated after interim data analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novozymes A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Mette Rose Jørgensen, DDS, PhD, Study director, Novozymes A/SSebastian Schlafer, DDS, PhD, Principal investigator, Aarhus University, Department of Dentistry and Oral Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082103
- Sponsor's protocol ID
- NZ-OHBFC-2021-01
- Status last verified
- Jun 2022
- First submitted
- 16 Sep 2021
- Last updated
- 9 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rikvold PD, Johnsen KK, Del Rey YC, Hansen LBS, Knap I, Holz C, Meyer RL, Jorgensen MR, Schlafer S. The Effect of Enzymes on Dental Plaque: A Randomized Controlled Trial. J Dent Res. 2026 Feb;105(2):236-244. doi: 10.1177/00220345251347959. Epub 2025 Jul 17.
PubMed 40676928
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enzyme-containing Lozenges on Dental Biofilm Accumulation in Healthy Individuals: A Randomized Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05082103
- Acronym / sponsor ID
- NZ-OHBFC-2021-01
- Conditions
- Dental Plaque
- Keywords
- Enzymes, Dental plaque, Gingivitis, Oral microbiome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated after interim data analysis
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Novozymes A/SIndustry (pharma, biotech, devices)
- Collaborators
- University of Aarhus
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 18 Oct 2021 (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 purpose of the study is to assess the effect of enzyme containing lozenges on dental plaque accumulation in healthy adults.
Detailed description
The purpose of the study is to examine the clinical effects of lozenges containing three extracellular matrix-degrading enzymes on dental plaque accumulation and removal, prevention of gingivitis, and oral microbiome composition after professional tooth cleaning, as compared to a placebo lozenge without enzymes. Two different concentrations of the enzymes will be tested, to investigate a potential dose-dependent effect of the enzymes. Furthermore, safety of the enzyme lozenge will be assessed by clinical evaluation of the oral mucosa. The null hypothesis is that treatment with enzyme-containing lozenges does not affect plaque accumulation as compared to a placebo control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enzyme lozenge 1 | Active comparator | Other: Enzyme lozenge 1The lozenge contains three plaque extracellular matrix degrading enzymes |
| Enzyme lozenge 2 | Active comparator | Other: Enzyme lozenge 2The concentration of the three enzymes in the "Enzyme lozenge 2" is threefold the enzyme concentration than in the "Enzyme lozenge 1" |
| Placebo lozenge | Placebo comparator | Other: Placebo lozengeThe placebo lozenge contains the same ingredients except for the enzymes and has an identical taste, color and texture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Generally healthy males and females ≥18 years of age.
- Able to read, sign and receive a copy of the signed informed consent form.
- Have at least 20 natural teeth.
Key exclusion criteria (9 listed)
- Clinically visible active caries lesions and/or periodontitis.
- Significant oral soft tissue pathology based on a visual examination.
- 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.
- History of allergies to ingredients in the test product.
- Self-reported as pregnant or nursing.
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 lozenge 1Participants are instructed to take one enzyme containing lozenge three times daily, at least 30 min after a meal, for 14 days. No normal oral hygiene procedures are allowed during the intervention period. | Other | Enzyme lozenge 1 |
| Enzyme lozenge 2Participants are instructed to take one lozenge with 3x higher enzyme concentration three times daily, at least 30 min after a meal, for 14 days. No normal oral hygiene procedures are allowed during the intervention period. | Other | Enzyme lozenge 2 |
| Placebo lozengeParticipants are instructed to take one placebo lozenge three times daily, at least 30 min after a meal, for 14 days. No normal oral hygiene procedures are allowed during the intervention period. | Other | Placebo lozenge |
Primary outcome
Plaque amount
Time frame: Change in QHPI score from baseline to 24 hours' follow-up
Dental plaque accumulation after 1-day use of either a test or placebo investigational lozenge assessed by the Turesky modified Quingly-Hein Plaque Index (QHPI) (score 0-5, 0 being no plaque, 5 being entire tooth covered with plaque)
5 secondary outcomes
Plaque amount
Time frame: Change in QHPI score from baseline to Day 7 follow-up and from baseline to Day 14 follow-up
Gingivitis
Time frame: Change in GI from baseline to Day 14 follow-up
Plaque removal
Time frame: Day 14 visit
Oral microbiome
Time frame: Change in microbiome composition from baseline to Day 14 follow-up
Plaque fluorescence intensity measurement
Time frame: Change in intensity measurement from baseline to Day 7 follow-up and Day 14 follow-up
Results and safety
The study was stopped early (reason given: The study was terminated after interim data analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Derived from this study: PubMed 40676928Rikvold PD, Johnsen KK, Del Rey YC, Hansen LBS, Knap I, Holz C, Meyer RL, Jorgensen MR, Schlafer S. The Effect of Enzymes on Dental Plaque: A Randomized Controlled Trial. J Dent Res. 2026 Feb;105(2):236-244. doi: 10.1177/00220345251347959. Epub 2025 Jul 17.
- 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.
Mette Rose Jørgensen, DDS, PhD study director
Novozymes A/S
Sebastian Schlafer, DDS, PhD principal investigator
Aarhus University, Department of Dentistry and Oral Health
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 lozenge 1 and Enzyme lozenge 2 in people with Dental Plaque, run by Novozymes A/S at 1 site in Denmark.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 9 Jun 2022. 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 Denmark. 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 was stopped early (reason given: The study was terminated after interim data analysis). Results are not available in the source record.
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?
Plaque amount (time frame: Change in QHPI score from baseline to 24 hours' follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05082103, which also lists 1 linked publication.
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 9 Jun 2022.