Dental PlaqueNCT05070507
Effect of an Enzyme-containing Lozenge on Dental Biofilm in Healthy Individuals.
A study testing Enzyme containing lozenge in people with Dental Plaque and Gingivitis, run by Novozymes A/S at 1 site in Denmark.
Trial summary
The purpose of the study is to assess the effect of an enzyme containing lozenge 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, Gingivitis, Microbial Colonization
- What is being tested?
- Enzyme containing lozenge
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Jan 2021to 10 May 2021
- 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.
- History of allergies towards enzymes.
- Self-reported as pregnant or nursing.
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- Self-reported serious medical conditions.
- 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.
About this study
Official title: Preventive Effect of an Enzyme-containing Lozenge on Dental Biofilm Accumulation in Healthy Individuals: A Clinical Pilot Study.
The purpose of the study is to assess the effect of an enzyme containing lozenge on dental plaque accumulation in healthy adults.
Read the detailed description
The purpose of this study is to examine the clinical effects of a lozenge containing enzymes on dental plaque accumulation and oral microbiome composition after professional dental cleaning, as compared to a placebo lozenge without enzymes. Furthermore, safety of the enzyme lozenge will be assessed by clinical evaluation of the oral hard and soft tissues. The null hypothesis is that the treatment with enzyme-containing lozenges do not affect plaque accumulation, as compared to a placebo control.
- Conditions
- Dental Plaque, Gingivitis, Microbial Colonization
- Being tested
- Enzyme containing lozenge, Placebo lozenge
- Medical subject headings
- Dental Plaque, Gingivitis, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzyme containing lozengeDietary supplement
Subjects are instructed to take one lozenge three times daily, at least 30 minutes after a meal, for seven days. No oral health care procedures are allowed during the intervention period.
Placebo lozengeDietary supplement
Subjects are instructed to take one lozenge three times daily, at least 30 minutes after a meal, for seven days. No oral health care procedures are allowed during the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Enzyme containing lozenge | Experimental | Not described Receives: Dietary Supplement: Enzyme containing lozenge |
| Placebo lozenge | Placebo comparator | Not described Receives: Dietary Supplement: Placebo lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulation of dental plaque after 24 hours
Dental plaque assessed by the modified Quigley-Hein Plaque Index
Measured: Change in dental plaque score from baseline to 24 hours' follow-up
Secondary outcomes (3)
Accumulation of dental plaque after 7 days
Dental plaque assessed by the modified Quigley-Hein Plaque Index
Measured: Change in dental plaque score from baseline to 7 days' follow-up
Development of gingivitis after 7 days
Gingivitis assessed by the Silness-Löe Plaque Index
Measured: Change in gingivitis score from baseline to 7 days' follow-up
Microbial characterization of the oral microbiome from plaque and saliva samples
Assessed by 16S rRNA sequencing
Measured: 7 days' follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start8 Jan 2021
- Primary completion26 Feb 2021
- Study completion10 May 2021
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novozymes A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Sebastian Schlafer, DDS, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070507
- Sponsor's protocol ID
- NZ-OHBFC-2020-04
- Status last verified
- Oct 2021
- First submitted
- 12 Sep 2021
- Last updated
- 7 Oct 2021
- Results posted
- 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 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Effect of an Enzyme-containing Lozenge on Dental Biofilm Accumulation in Healthy Individuals: A Clinical Pilot Study.
- ClinicalTrials.gov ID
- NCT05070507
- Acronym / sponsor ID
- NZ-OHBFC-2020-04
- Conditions
- Dental Plaque, Gingivitis, Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novozymes A/SIndustry (pharma, biotech, devices)
- Collaborators
- University of Aarhus
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 7 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 an enzyme containing lozenge on dental plaque accumulation in healthy adults.
Detailed description
The purpose of this study is to examine the clinical effects of a lozenge containing enzymes on dental plaque accumulation and oral microbiome composition after professional dental cleaning, as compared to a placebo lozenge without enzymes. Furthermore, safety of the enzyme lozenge will be assessed by clinical evaluation of the oral hard and soft tissues. The null hypothesis is that the treatment with enzyme-containing lozenges do not affect plaque accumulation, as compared to a placebo control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enzyme containing lozenge | Experimental | Dietary Supplement: Enzyme containing lozenge |
| Placebo lozenge | Placebo comparator | Dietary Supplement: Placebo lozenge |
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 (10 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.
- History of allergies towards enzymes.
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 lozengeSubjects are instructed to take one lozenge three times daily, at least 30 minutes after a meal, for seven days. No oral health care procedures are allowed during the intervention period. | Dietary supplement | Enzyme containing lozenge |
| Placebo lozengeSubjects are instructed to take one lozenge three times daily, at least 30 minutes after a meal, for seven days. No oral health care procedures are allowed during the intervention period. | Dietary supplement | Placebo lozenge |
Primary outcome
Accumulation of dental plaque after 24 hours
Time frame: Change in dental plaque score from baseline to 24 hours' follow-up
Dental plaque assessed by the modified Quigley-Hein Plaque Index
3 secondary outcomes
Accumulation of dental plaque after 7 days
Time frame: Change in dental plaque score from baseline to 7 days' follow-up
Development of gingivitis after 7 days
Time frame: Change in gingivitis score from baseline to 7 days' follow-up
Microbial characterization of the oral microbiome from plaque and saliva samples
Time frame: 7 days' follow-up
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 7 Oct 2021.
- 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.
Sebastian Schlafer, DDS, PhD principal investigator
University of Aarhus
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 and Gingivitis, 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 10 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 7 Oct 2021. 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 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?
Accumulation of dental plaque after 24 hours (time frame: Change in dental plaque 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?
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 7 Oct 2021.