Dental Biofilm AccumulationNCT06142409
Effect of Enzyme-containing Lozenge on Dental Biofilm Formation, Composition and Functionality
A study testing Enzyme containing lozenge in people with Dental Biofilm Accumulation, run by Novozymes A/S at 1 site in Denmark.
Trial summary
A double-blind, placebo-controlled randomized cross-over trial evaluating the effect of enzyme-containing lozenge on in vivo and in situ grown dental biofilm accumulation. The study includes two phases, one each for the investigation of in-vivo and in-situ grown dental biofilm Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Biofilm Accumulation
- What is being tested?
- Enzyme containing lozenge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Aug 2023to 25 Feb 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years old.
- Have three or more active carious lesions.
- Anatomically possible to manufacture an intraoral lower-jaw splint.
- Able to understand and follow instructions, as well as to read and sign the informed consent form.
- A plaque index score ≥ 2 according to the Turesky Modification of the Quigley-Hein Plaque Index (TM-QHPI), following 8 to 12 hours plaque accumulation period.
Who cannot join
- History of allergies towards any of the ingredients in the test products
- Self-reported pregnant or nursing
- Antibiotic or anti-inflammatory medication within 90 days of the screening visit.
- Orthodontic appliances, including retainers, or removable partial dentures.
- Self-reported serious medical conditions
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Dentistry and Oral Health, Aarhus University
Aarhus, DK-8000 Aarhus C
About this study
Official title: The Effect of Non-biocidal Adjuncts on the Formation, Composition, Functionality, and Microscale Architecture of Dental Biofilms: a Randomized Controlled Trial
A double-blind, placebo-controlled randomized cross-over trial evaluating the effect of enzyme-containing lozenge on in vivo and in situ grown dental biofilm accumulation. The study includes two phases, one each for the investigation of in-vivo and in-situ grown dental biofilm
Read the detailed description
Up to 50 subjects (aged ≥ 18 years old) with 3 or more active caries lesion, will be randomized to receive:
Phase 1: The effect of multiple-enzyme treatment on plaque accumulation in vivo
Phase 1 includes two experimental periods lasting for one day each, with a washout period of two weeks in between. Each experimental period will include two visits, at day 0 and day 1.
At day 0, the participants will receive a professional tooth cleaning and be randomized to receive Sequence 1 or Sequence 2 in a double-blind randomized cross-over design:
Sequence 1: 3 active enzyme-containing lozenges per day for one day (app. 24h) followed by a washout period of two weeks, followed by 3 identical placebo lozenges per day for one day (app. 24h).
Sequence 2: 3 placebo lozenges per day for one day (app. 24h) followed by a washout period of two weeks, followed by 3 identical active enzyme lozenges per day for one day (app. 24h).
The participants will be instructed to take one lozenge three times (morning, noon, evening) for one day. No normal oral hygiene procedures will be allowed during the intervention periods of one day. At the end of both experimental phases, plaque is assessed using planimetric recordings obtained with an intraoral camera and TM-QHPI to provide information on the individual level of plaque formation.
Phase 2: The effect of multiple-enzyme treatment on in situ-grown biofilms
The phase is designed in a double-blind randomized cross-over design, including two experimental periods lasting for 2 days, with a washout period of 5 days in between. Each experimental period will include two visits, on day 0 and day 2. Oral biofilms will be grown in situ on prefabricated non-fluorescent glass slabs for 48 hours. The glass slabs will be mounted on the individual lower-jaw splints.
At day 0, the participants will be randomized to receive Sequence 1 or Sequence 2:
Sequence 1: 3 active enzyme-containing lozenges per day for 2 days followed by a washout period of 5 days, followed by 3 identical placebo lozenges per day for 2 days.
Sequence 2: 3 placebo lozenges per day for 2 days followed by a washout period of 5 days, followed by 3 identical active enzyme lozenges per day for 2 days.
Oral biofilms will be grown in situ on prefabricated non-fluorescent glass slabs for 2-4 experimental periods of 48 hours. After each experimental period, the in situ-grown biofilms will be collected and stored in a research biobank.
- Conditions
- Dental Biofilm Accumulation
- Being tested
- Enzyme containing lozenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzyme containing lozengeDietary supplement
Lozenge containing multiple enzyme combination
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Active comparator | Enzyme-containing lozenge Receives: Dietary Supplement: Enzyme containing lozenge |
| Placebo arm | Placebo comparator | Placebo lozenge Receives: Dietary Supplement: Enzyme containing lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in in-vivo dental biofilm accumulation
To investigate the effect of an enzyme-containing lozenge on dental biofilm accumulation in caries-active subjects in vivo assessed by the planimetric plaque index (PPI)
Measured: 1 day
Secondary outcomes (3)
Change in in-vivo dental biofilm accumulation
To investigate the effect of an enzyme-containing lozenge on dental biofilm accumulation in caries-active subjects in vivo assessed by the Turesky-modified Quigley Hein Plaque Index (TM-QHPI)
Measured: 1 days
Change in in-situ grown dental biofilm accumulation
The effect of enzyme-containing lozenge on changes in the microarchitecture of in situ-grown biofilms from caries-active subjects analyzed by optical coherence tomography.
Measured: 2 days
Change in oral microbial community composition of in-situ grown dental biofilm
Shift in oral microbial community composition of in situ-grown biofilms from caries-active subjects assessed by next-generation sequencing of 16S rRNA genes
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start17 Aug 2023
- Primary completion25 Feb 2024
- Study completion25 Feb 2024
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novozymes A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142409
- Sponsor's protocol ID
- NZ-2022-05
- Status last verified
- Jan 2025
- First submitted
- 16 Nov 2023
- Last updated
- 3 Jan 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 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-biocidal Adjuncts on the Formation, Composition, Functionality, and Microscale Architecture of Dental Biofilms: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06142409
- Acronym / sponsor ID
- NZ-2022-05
- Conditions
- Dental Biofilm Accumulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Novozymes A/SIndustry (pharma, biotech, devices)
- Collaborators
- University of Aarhus
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 21 Nov 2023 (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.
A double-blind, placebo-controlled randomized cross-over trial evaluating the effect of enzyme-containing lozenge on in vivo and in situ grown dental biofilm accumulation. The study includes two phases, one each for the investigation of in-vivo and in-situ grown dental biofilm
Detailed description
Up to 50 subjects (aged ≥ 18 years old) with 3 or more active caries lesion, will be randomized to receive:
Phase 1: The effect of multiple-enzyme treatment on plaque accumulation in vivo
Phase 1 includes two experimental periods lasting for one day each, with a washout period of two weeks in between. Each experimental period will include two visits, at day 0 and day 1.
At day 0, the participants will receive a professional tooth cleaning and be randomized to receive Sequence 1 or Sequence 2 in a double-blind randomized cross-over design:
Sequence 1: 3 active enzyme-containing lozenges per day for one day (app. 24h) followed by a washout period of two weeks, followed by 3 identical placebo lozenges per day for one day (app. 24h).
Sequence 2: 3 placebo lozenges per day for one day (app. 24h) followed by a washout period of two weeks, followed by 3 identical active enzyme lozenges per day for one day (app. 24h).
The participants will be instructed to take one lozenge three times (morning, noon, evening) for one day. No normal oral hygiene procedures will be allowed during the intervention periods of one day. At the end of both experimental phases, plaque is assessed using planimetric recordings obtained with an intraoral camera and TM-QHPI to provide information on the individual level of plaque formation.
Phase 2: The effect of multiple-enzyme treatment on in situ-grown biofilms
The phase is designed in a double-blind randomized cross-over design, including two experimental periods lasting for 2 days, with a washout period of 5 days in between. Each experimental period will include two visits, on day 0 and day 2. Oral biofilms will be grown in situ on prefabricated non-fluorescent glass slabs for 48 hours. The glass slabs will be mounted on the individual lower-jaw splints.
At day 0, the participants will be randomized to receive Sequence 1 or Sequence 2:
Sequence 1: 3 active enzyme-containing lozenges per day for 2 days followed by a washout period of 5 days, followed by 3 identical placebo lozenges per day for 2 days.
Sequence 2: 3 placebo lozenges per day for 2 days followed by a washout period of 5 days, followed by 3 identical active enzyme lozenges per day for 2 days.
Oral biofilms will be grown in situ on prefabricated non-fluorescent glass slabs for 2-4 experimental periods of 48 hours. After each experimental period, the in situ-grown biofilms will be collected and stored in a research biobank.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active arm | Active comparator | Dietary Supplement: Enzyme containing lozengeEnzyme-containing lozenge |
| Placebo arm | Placebo comparator | Dietary Supplement: Enzyme containing lozengePlacebo lozenge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females ≥ 18 years old.
- Have three or more active carious lesions.
- Anatomically possible to manufacture an intraoral lower-jaw splint.
- Able to understand and follow instructions, as well as to read and sign the informed consent form.
- A plaque index score ≥ 2 according to the Turesky Modification of the Quigley-Hein Plaque Index (TM-QHPI), following 8 to 12 hours plaque accumulation period.
Key exclusion criteria (5 listed)
- History of allergies towards any of the ingredients in the test products
- Self-reported pregnant or nursing
- Antibiotic or anti-inflammatory medication within 90 days of the screening visit.
- Orthodontic appliances, including retainers, or removable partial dentures.
- 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 |
|---|---|---|
| Enzyme containing lozengeLozenge containing multiple enzyme combination | Dietary supplement | Active arm, Placebo arm |
Primary outcome
Change in in-vivo dental biofilm accumulation
Time frame: 1 day
To investigate the effect of an enzyme-containing lozenge on dental biofilm accumulation in caries-active subjects in vivo assessed by the planimetric plaque index (PPI)
3 secondary outcomes
Change in in-vivo dental biofilm accumulation
Time frame: 1 days
Change in in-situ grown dental biofilm accumulation
Time frame: 2 days
Change in oral microbial community composition of in-situ grown dental biofilm
Time frame: 2 days
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 3 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Biofilm Accumulation, 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 5 inclusion and 5 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 3 Jan 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 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?
Change in in-vivo dental biofilm accumulation (time frame: 1 day). 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 3 Jan 2025.