Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals

NCT ID: NCT05082103

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2022-03-31

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.

Conditions

Dental Plaque

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Enzyme lozenge 1

The lozenge contains three plaque extracellular matrix degrading enzymes

Group Type: ACTIVE_COMPARATOR

Enzyme lozenge 1

Intervention Type: OTHER

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.

Enzyme lozenge 2

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

Group Type: ACTIVE_COMPARATOR

Enzyme lozenge 2

Intervention Type: OTHER

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.

Placebo lozenge

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

Group Type: PLACEBO_COMPARATOR

Placebo lozenge

Intervention Type: OTHER

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.

Interventions

Enzyme lozenge 1

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

Enzyme lozenge 2

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

Placebo lozenge

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: collaborator

Novozymes A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mette Rose Jørgensen, DDS, PhD

Role: STUDY_DIRECTOR

Novozymes A/S

Sebastian Schlafer, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University, Department of Dentistry and Oral Health

Locations

Aarhus University, Department of Dentistry and Oral Health

Aarhus, , Denmark

Countries

Denmark

References

Rikvold PD, Johnsen KK, Del Rey YC, Hansen LBS, Knap I, Holz C, Meyer RL, Jorgensen MR, Schlafer S. The Effect of Enzymes on Dental Plaque: A Randomized Controlled Trial. J Dent Res. 2025 Jul 17:220345251347959. doi: 10.1177/00220345251347959. Online ahead of print.

Reference Type: DERIVED

PMID: 40676928 (View on PubMed)

Other Identifiers

NZ-OHBFC-2021-01

Identifier Type: -

Identifier Source: org_study_id