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

NCT05070507 | Completed

• 1 other identifier: NZ-OHBFC-2020-04
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Plaque; Gingivitis; Microbial Colonization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Accumulation of dental plaque after 7 days

  Change in dental plaque score from baseline to 7 days' follow-up

• Development of gingivitis after 7 days

  Change in gingivitis score from baseline to 7 days' follow-up

• Microbial characterization of the oral microbiome from plaque and saliva samples

  7 days' follow-up

Study Arms (2)

Enzyme containing lozenge

EXPERIMENTAL

Dietary Supplement: Enzyme containing lozenge

Placebo lozenge

PLACEBO COMPARATOR

Dietary Supplement: Placebo lozenge

Interventions

Enzyme containing lozenge DIETARY_SUPPLEMENT

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.

Enzyme containing lozenge

Placebo lozenge DIETARY_SUPPLEMENT

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 lozenge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novozymes A/S: lead
• University of Aarhus: collaborator

Study Sites (1)

Aarhus University

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis; Communicable Diseases

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sebastian Schlafer, DDS, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: October 7, 2021
• Study Start: January 8, 2021
• Primary Completion: February 26, 2021
• Study Completion: May 10, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)