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

Preventive Effect of an Enzyme-containing Lozenge on Dental Biofilm Accumulation in Healthy Individuals: A Clinical Pilot Study.

The purpose of the study is to assess the effect of an enzyme containing lozenge on dental plaque accumulation in healthy adults.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Microbial Colonization; Dental Plaque
• Intervention / Treatment: Dietary supplement: Enzyme containing lozenge; Dietary supplement: Placebo lozenge

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• 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.
• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enzyme containing lozenge	Dietary supplement: Enzyme containing lozenge; 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.
Placebo Comparator: Placebo lozenge	Dietary supplement: Placebo lozenge; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accumulation of dental plaque after 24 hours	Dental plaque assessed by the modified Quigley-Hein Plaque Index	Change in dental plaque score from baseline to 24 hours' follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accumulation of dental plaque after 7 days	Dental plaque assessed by the modified Quigley-Hein Plaque Index	Change in dental plaque score from baseline to 7 days' follow-up
Development of gingivitis after 7 days	Gingivitis assessed by the Silness-Löe Plaque Index	Change in gingivitis score from baseline to 7 days' follow-up
Microbial characterization of the oral microbiome from plaque and saliva samples	Assessed by 16S rRNA sequencing	7 days' follow-up

Collaborators and Investigators

• Sponsor: Novozymes A/S
• Collaborators: University of Aarhus
• Investigators: Principal Investigator: Sebastian Schlafer, DDS, PhD, University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Actual): February 26, 2021
• Study Completion (Actual): May 10, 2021

Study Registration Dates

• First Submitted: September 12, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Tooth Diseases; Dental Deposits; Infections; Communicable Diseases; Gingivitis; Dental Plaque
• Other Study ID Numbers: NZ-OHBFC-2020-04

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