Effect of Enzymes on Dental Biofilm Accumulation
Primary Purpose
Dental Plaque
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enzyme-containing lozenge
Placebo lozenge
Sponsored by
About this trial
This is an interventional treatment trial for Dental Plaque focused on measuring Enzymes, Dental biofilm, Dental plaque
Eligibility Criteria
Inclusion Criteria:
- Generally healthy males and females 18-75 years of age.
- Able to read, sign and receive a copy of the signed informed consent form.
- Have at least 20 natural teeth with scorable facial and lingual surfaces. A scorable tooth is defined as having at least 2/3 of the natural tooth surface evaluable for the selected clinical measurements. The following will not be included in the scorable tooth count: third molars; teeth that are fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth; teeth exhibiting general cervical abrasion and/or enamel abrasion and calculus deposits which, in the opinion of the clinical examiner, would interfere with the assessments)..
- Willing to refrain from all oral hygiene 8-12 hours prior to Screening visit.
- Willing to refrain from use of chewing gum over the course of the 4-day intervention periods
At the Screening Visit, subject presents with:
a. A plaque index score ≥ 1.95 according to the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index, following 8 to 12 hours plaque accumulation period.
- Willing and able to comply with scheduled visits, treatment plan and other study procedures.
- Willing to refrain from all oral hygiene (with the exception of lozenge consumption 5 times per day) for a 96-hour (4-day) period between Visits 2-4/Visits 5-7
- Willing to refrain from the use of chemotherapeutic antiplaque/antigingivitis products containing antibacterial agents such as, but not limited to, amine fluoride, chlorhexidine, stannous fluoride, essential oils, cetylpyridinium chloride, etc. and other oral hygiene products during the study.
Exclusion Criteria:
- A subject with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the subject inappropriate for entry into this study.
- Subject self-reported as currently pregnant, or breastfeeding or subject intends to become pregnant through the duration of the study.
- Uncontrolled diabetes or hypertension.
- Health condition requirement for antibiotic premedication prior to dental procedures.
- Current history of antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 30 days of Screening visit.
- Subject is a smoker or user of smokeless tobacco, nicotine containing products (including chewing gum, patches, pouches or mints).
- Subject has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- Presence of moderate or severe periodontal disease (Stage II, III or IV), or actively under treatment for periodontal disease.
- Presence of orthodontic appliances, peri/oral piercings, or removable partial dentures.
- 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.
- A subject with high levels of extrinsic stain, calculus deposits or severely inflamed tissues which might interfere with dental plaque assessments.
- Have significant intra-oral soft tissue lesions due to pathology or trauma based on a visual examination.
Sites / Locations
- Salus Research Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Verum Lozenges
Identical Placebo Lozenges
Arm Description
Active enzyme-containing lozenges to be consumed 5 times per day for 4 days
Placebo lozenges to be consumed 5 times per day for 4 days
Outcomes
Primary Outcome Measures
4-day biofilm accumulation in the absence of oral mechanical hygiene
Biofilm accumulation is assessed by the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index (PLI)
Secondary Outcome Measures
24-hour biofilm accumulation in the absence of oral mechanical hygiene
Biofilm accumulation is assessed by the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index (PLI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05579938
Brief Title
Effect of Enzymes on Dental Biofilm Accumulation
Official Title
A Randomised, Double-blind Clinical Trial to Determine the Effect of a Lozenge Containing Enzymes on Dental Biofilm Accumulation in Healthy Adults Using a 4-day Plaque Regrowth Model.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
October 19, 2022 (Actual)
Study Completion Date
November 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novozymes A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Double-blind, placebo-controlled, cross-over study investigating dental biofilm accumulation after 4-days in 28 subjects randomised to receive:
Sequence 1: 5 active enzyme-containing lozenges per day for 4-days followed by a 2-week washout period followed by 5 identical placebo lozenges per day for 4-days or
Sequence 2: 5 placebo lozenges per day for 4-days followed by a 2-week washout period followed by 5 identical active enzyme lozenges per day for 4-days
Detailed Description
28 healthy subjects (aged 18-75y) will be randomised to receive Sequence 1 or Sequence 2 in a double-blind, placebo-controlled cross-over study. Subjects will refrain from all mechanical oral hygiene over the course of each 4-day intervention period (e.g. no brushing, flossing, chewing gum) and will brush twice daily with a standard ADA accepted toothbrush and fluoride toothpaste during the 2-week washout period.
Sequence 1: 5 active enzyme-containing lozenges per day for 4-days followed by a 2-week washout period followed by 5 id entical placebo lozenges per day for 4-days or
Sequence 2: 5 placebo lozenges per day for 4-days followed by a 2-week washout period followed by 5 identical active enzyme lozenges per day for 4-days.
The primary outcome measure is 4-day biofilm accumulation as assessed by the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index score from Baseline (following dental prophy and score of 0) to Day 4 in the absence of oral mechanical hygiene (e.g. brushing, flossing).
The secondary outcome measure is 24-hour biofilm accumulation as assessed by the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index score from Baseline (following dental prophy and score of 0) to Day 1 (approximately 24-hours) in the absence of oral mechanical hygiene (e.g. brushing, flossing).
Exploratory measures include:
Shift in S. mutans relative abundance and richness (number of species) from baseline to Day 4 based on Next Generation Sequencing (alpha/beta diversity and individual Amplicon Sequence Variants [ASV] measured by 16S sequencing)
Shift in detected oral bacterial species of interest from baseline to Day 4, based on Next Generation Sequencing (alpha/beta diversity and individual Amplicon Sequence Variants [ASV] measured by 16S sequencing)
Change in IL-1-beta, IL-6, IL-8 and TNF-alpha from baseline to Day 4, based on electrochemiluminescence assay
Post-product use questionnaire (developed by sponsor) after 4 days of product use
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
Keywords
Enzymes, Dental biofilm, Dental plaque
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Verum Lozenges
Arm Type
Active Comparator
Arm Description
Active enzyme-containing lozenges to be consumed 5 times per day for 4 days
Arm Title
Identical Placebo Lozenges
Arm Type
Placebo Comparator
Arm Description
Placebo lozenges to be consumed 5 times per day for 4 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Enzyme-containing lozenge
Intervention Description
A lozenge containing 3 active enzymes
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo lozenge
Intervention Description
Identical placebo lozenge
Primary Outcome Measure Information:
Title
4-day biofilm accumulation in the absence of oral mechanical hygiene
Description
Biofilm accumulation is assessed by the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index (PLI)
Time Frame
4-day biofilm accumulation from Baseline following dental prophylaxis (score of 0) to Day 4
Secondary Outcome Measure Information:
Title
24-hour biofilm accumulation in the absence of oral mechanical hygiene
Description
Biofilm accumulation is assessed by the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index (PLI)
Time Frame
24-hour biofilm accumulation from Baseline following dental prophylaxis (score of 0) to 24-hours
Other Pre-specified Outcome Measures:
Title
Abundance of salivary and plaque S. mutans
Description
alpha/beta diversity measured by 16S rRNA sequencing
Time Frame
4-days (Baseline to Day 4) for each crossover period
Title
Shift in detected plaque and saliva bacterial species of interest
Description
Analysis will be based on Next Generation Sequencing (alpha/beta diversity and individual Amplicon Sequence Variants [ASV] measured by 16S rRNA sequencing
Time Frame
4-days (Baseline to Day 4) for each crossover period
Title
Change in inflammatory markers from Baseline to Day 4
Description
Analysis of IL-1-beta, IL-6, IL-8 and TNF-alpha will be based on electrochemiluminescence assay
Time Frame
4-days (Baseline to Day 4)
Title
Post-product use questionnaire
Description
Consumer-based questionnaire developed by Sponsor
Time Frame
4-days (Baseline to Day 4) for each crossover period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Generally healthy males and females 18-75 years of age.
Able to read, sign and receive a copy of the signed informed consent form.
Have at least 20 natural teeth with scorable facial and lingual surfaces. A scorable tooth is defined as having at least 2/3 of the natural tooth surface evaluable for the selected clinical measurements. The following will not be included in the scorable tooth count: third molars; teeth that are fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth; teeth exhibiting general cervical abrasion and/or enamel abrasion and calculus deposits which, in the opinion of the clinical examiner, would interfere with the assessments)..
Willing to refrain from all oral hygiene 8-12 hours prior to Screening visit.
Willing to refrain from use of chewing gum over the course of the 4-day intervention periods
At the Screening Visit, subject presents with:
a. A plaque index score ≥ 1.95 according to the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index, following 8 to 12 hours plaque accumulation period.
Willing and able to comply with scheduled visits, treatment plan and other study procedures.
Willing to refrain from all oral hygiene (with the exception of lozenge consumption 5 times per day) for a 96-hour (4-day) period between Visits 2-4/Visits 5-7
Willing to refrain from the use of chemotherapeutic antiplaque/antigingivitis products containing antibacterial agents such as, but not limited to, amine fluoride, chlorhexidine, stannous fluoride, essential oils, cetylpyridinium chloride, etc. and other oral hygiene products during the study.
Exclusion Criteria:
A subject with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the subject inappropriate for entry into this study.
Subject self-reported as currently pregnant, or breastfeeding or subject intends to become pregnant through the duration of the study.
Uncontrolled diabetes or hypertension.
Health condition requirement for antibiotic premedication prior to dental procedures.
Current history of antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 30 days of Screening visit.
Subject is a smoker or user of smokeless tobacco, nicotine containing products (including chewing gum, patches, pouches or mints).
Subject has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
Presence of moderate or severe periodontal disease (Stage II, III or IV), or actively under treatment for periodontal disease.
Presence of orthodontic appliances, peri/oral piercings, or removable partial dentures.
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.
A subject with high levels of extrinsic stain, calculus deposits or severely inflamed tissues which might interfere with dental plaque assessments.
Have significant intra-oral soft tissue lesions due to pathology or trauma based on a visual examination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffery L Milleman, DDS, MPA
Organizational Affiliation
Salus Research Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salus Research Inc
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Enzymes on Dental Biofilm Accumulation
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