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Effect of an Enzyme-containing Lozenge on Dental Biofilm in Healthy Individuals.

Primary Purpose

Dental Plaque, Gingivitis, Microbial Colonization

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Enzyme containing lozenge
Placebo lozenge
Sponsored by
Novozymes A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Plaque

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.
  • History of allergies towards enzymes.
  • 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Enzyme containing lozenge

Placebo lozenge

Arm Description

Outcomes

Primary Outcome Measures

Accumulation of dental plaque after 24 hours
Dental plaque assessed by the modified Quigley-Hein Plaque Index

Secondary Outcome Measures

Accumulation of dental plaque after 7 days
Dental plaque assessed by the modified Quigley-Hein Plaque Index
Development of gingivitis after 7 days
Gingivitis assessed by the Silness-Löe Plaque Index
Microbial characterization of the oral microbiome from plaque and saliva samples
Assessed by 16S rRNA sequencing

Full Information

First Posted
September 12, 2021
Last Updated
October 5, 2021
Sponsor
Novozymes A/S
Collaborators
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT05070507
Brief Title
Effect of an Enzyme-containing Lozenge on Dental Biofilm in Healthy Individuals.
Official Title
Preventive Effect of an Enzyme-containing Lozenge on Dental Biofilm Accumulation in Healthy Individuals: A Clinical Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 8, 2021 (Actual)
Primary Completion Date
February 26, 2021 (Actual)
Study Completion Date
May 10, 2021 (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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque, Gingivitis, Microbial Colonization

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enzyme containing lozenge
Arm Type
Experimental
Arm Title
Placebo lozenge
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Enzyme containing lozenge
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo lozenge
Intervention Description
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.
Primary Outcome Measure Information:
Title
Accumulation of dental plaque after 24 hours
Description
Dental plaque assessed by the modified Quigley-Hein Plaque Index
Time Frame
Change in dental plaque score from baseline to 24 hours' follow-up
Secondary Outcome Measure Information:
Title
Accumulation of dental plaque after 7 days
Description
Dental plaque assessed by the modified Quigley-Hein Plaque Index
Time Frame
Change in dental plaque score from baseline to 7 days' follow-up
Title
Development of gingivitis after 7 days
Description
Gingivitis assessed by the Silness-Löe Plaque Index
Time Frame
Change in gingivitis score from baseline to 7 days' follow-up
Title
Microbial characterization of the oral microbiome from plaque and saliva samples
Description
Assessed by 16S rRNA sequencing
Time Frame
7 days' follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
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. History of allergies towards enzymes. 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
Sebastian Schlafer, DDS, PhD
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of an Enzyme-containing Lozenge on Dental Biofilm in Healthy Individuals.

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