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Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals

Primary Purpose

Dental Plaque

Status

Terminated

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Enzyme lozenge 1

Enzyme lozenge 2

Placebo lozenge

About this trial

This is an interventional prevention trial for Dental Plaque focused on measuring Enzymes, Dental plaque, Gingivitis, Oral microbiome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Aarhus University, Department of Dentistry and Oral Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Enzyme lozenge 1

Enzyme lozenge 2

Placebo lozenge

Arm Description

The lozenge contains three plaque extracellular matrix degrading enzymes

The concentration of the three enzymes in the "Enzyme lozenge 2" is threefold the enzyme concentration than in the "Enzyme lozenge 1"

The placebo lozenge contains the same ingredients except for the enzymes and has an identical taste, color and texture

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

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)

Plaque removal

Plaque removal by mechanical treatment with a water-/airpik. The technique will be applied professionally at the clinical site by co-investigator.

Oral microbiome

Oral microbiome composition

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.

Full Information

NCT ID

NCT05082103

First Posted

September 16, 2021

Last Updated

June 7, 2022

Sponsor

Novozymes A/S

Collaborators

University of Aarhus

1. Study Identification

Unique Protocol Identification Number

NCT05082103

Brief Title

Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals

Official Title

Effect of Enzyme-containing Lozenges on Dental Biofilm Accumulation in Healthy Individuals: A Randomized Placebo-controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated after interim data analysis

Study Start Date

September 15, 2021 (Actual)

Primary Completion Date

March 31, 2022 (Actual)

Study Completion Date

March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novozymes A/S

Collaborators

University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Plaque

Keywords

Enzymes, Dental plaque, Gingivitis, Oral microbiome

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Enzyme lozenge 1

Arm Type

Active Comparator

Arm Description

The lozenge contains three plaque extracellular matrix degrading enzymes

Arm Title

Enzyme lozenge 2

Arm Type

Active Comparator

Arm Description

The concentration of the three enzymes in the "Enzyme lozenge 2" is threefold the enzyme concentration than in the "Enzyme lozenge 1"

Arm Title

Placebo lozenge

Arm Type

Placebo Comparator

Arm Description

The placebo lozenge contains the same ingredients except for the enzymes and has an identical taste, color and texture

Intervention Type

Other

Intervention Name(s)

Enzyme lozenge 1

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Enzyme lozenge 2

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo lozenge

Intervention Description

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.

Primary Outcome Measure Information:

Title

Plaque amount

Description

Time Frame

Change in QHPI score from baseline to 24 hours' follow-up

Secondary Outcome Measure Information:

Title

Plaque amount

Description

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)

Time Frame

Change in QHPI score from baseline to Day 7 follow-up and from baseline to Day 14 follow-up

Title

Gingivitis

Description

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)

Time Frame

Change in GI from baseline to Day 14 follow-up

Title

Plaque removal

Description

Plaque removal by mechanical treatment with a water-/airpik. The technique will be applied professionally at the clinical site by co-investigator.

Time Frame

Day 14 visit

Title

Oral microbiome

Description

Oral microbiome composition

Time Frame

Change in microbiome composition from baseline to Day 14 follow-up

Title

Plaque fluorescence intensity measurement

Description

Time Frame

Change in intensity measurement from baseline to Day 7 follow-up and Day 14 follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mette Rose Jørgensen, DDS, PhD

Organizational Affiliation

Novozymes A/S

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Sebastian Schlafer, DDS, PhD

Organizational Affiliation

Aarhus University, Department of Dentistry and Oral Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aarhus University, Department of Dentistry and Oral Health

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals

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