Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals

NCT05082103 | Terminated

• 1 other identifier: NZ-OHBFC-2021-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Plaque

Keywords

Enzymes; Dental plaque; Gingivitis; Oral microbiome

Outcome Measures

Primary Outcomes (1)

• Plaque amount

  Dental plaque accumulation after 1-day use of either a test or placebo investigational lozenge assessed by the Turesky modified Quingly-Hein Plaque Index (QHPI) (score 0-5, 0 being no plaque, 5 being entire tooth covered with plaque)

  Change in QHPI score from baseline to 24 hours' follow-up

Secondary Outcomes (5)

• Plaque amount

  Change in QHPI score from baseline to Day 7 follow-up and from baseline to Day 14 follow-up

• Gingivitis

  Change in GI from baseline to Day 14 follow-up

• Plaque removal

  Day 14 visit

• Oral microbiome

  Change in microbiome composition from baseline to Day 14 follow-up

• Plaque fluorescence intensity measurement

  Change in intensity measurement from baseline to Day 7 follow-up and Day 14 follow-up

Study Arms (3)

Enzyme lozenge 1

ACTIVE COMPARATOR

The lozenge contains three plaque extracellular matrix degrading enzymes

Other: Enzyme lozenge 1

Enzyme lozenge 2

ACTIVE COMPARATOR

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

Other: Enzyme lozenge 2

Placebo lozenge

PLACEBO COMPARATOR

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

Other: Placebo lozenge

Interventions

Enzyme lozenge 1 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 1

Enzyme lozenge 2 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.

Enzyme lozenge 2

Placebo lozenge 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.

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.
• 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, Department of Dentistry and Oral Health

Aarhus, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40676928 DERIVED

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• Mette Rose Jørgensen, DDS, PhD

  Novozymes A/S

  STUDY DIRECTOR

• Sebastian Schlafer, DDS, PhD

  Aarhus University, Department of Dentistry and Oral Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 18, 2021
• Study Start: September 15, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)