Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals

June 7, 2022 updated by: Novozymes A/S

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University, Department of Dentistry and Oral Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Enzyme lozenge 1
The lozenge contains three plaque extracellular matrix degrading enzymes
Other: Enzyme lozenge 1
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.
Active Comparator: Enzyme lozenge 2
The concentration of the three enzymes in the "Enzyme lozenge 2" is threefold the enzyme concentration than in the "Enzyme lozenge 1"
Other: Enzyme lozenge 2
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 Comparator: Placebo lozenge
The placebo lozenge contains the same ingredients except for the enzymes and has an identical taste, color and texture
Other: Placebo lozenge
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Change in QHPI score from baseline to 24 hours' follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plaque amount
Time Frame: Change in QHPI score from baseline to Day 7 follow-up and from baseline to Day 14 follow-up
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)
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
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)
Change in GI from baseline to Day 14 follow-up
Plaque removal
Time Frame: Day 14 visit
Plaque removal by mechanical treatment with a water-/airpik. The technique will be applied professionally at the clinical site by co-investigator.
Day 14 visit
Oral microbiome
Time Frame: Change in microbiome composition from baseline to Day 14 follow-up
Oral microbiome composition
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
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.
Change in intensity measurement from baseline to Day 7 follow-up and Day 14 follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novozymes A/S

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Aarhus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mette Rose Jørgensen, DDS, PhD, Novozymes A/S
  • Principal Investigator: Sebastian Schlafer, DDS, PhD, Aarhus University, Department of Dentistry and Oral Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NZ-OHBFC-2021-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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