Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals

Not Applicable

Terminated

• Conditions: Dental Plaque
• Interventions: Other: Enzyme lozenge 1; Other: Placebo lozenge; Other: Enzyme lozenge 2

• Registration Number: NCT05082103
• Lead Sponsor: Novozymes A/S

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.

Study Timeline

• Study Start: 2021-09-15
• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-18
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enzyme lozenge 1	Enzyme lozenge 1	The lozenge contains three plaque extracellular matrix degrading enzymes
Placebo lozenge	Placebo lozenge	The placebo lozenge contains the same ingredients except for the enzymes and has an identical taste, color and texture
Enzyme lozenge 2	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"

Primary Outcome Measures

Name	Time	Method
Plaque amount	Change in QHPI score from baseline to 24 hours' follow-up	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)

Secondary Outcome Measures

Name	Time	Method
Gingivitis	Change in GI from baseline to Day 14 follow-up	Development of gingivitis after 14 days assessed by the Gingival Index of Löe and Silness (GI) (score 0-3, 0 being no gingivitis, 3 being excessive gingivitis)
Plaque fluorescence intensity measurement	Change in intensity measurement from baseline to Day 7 follow-up and Day 14 follow-up	Dental plaque accumulation assessed by fluorescence intensity measurements, to provide information on the individual level of plaque formation. Soft biofilm on the teeth is calculated using an appropriate software program, compatible with the device used.
Plaque amount	Change in QHPI score from baseline to Day 7 follow-up and from baseline to Day 14 follow-up	Dental plaque accumulation after 7 and 14 days assessed by the Turesky modified Quingly-Hein Plaque Index (QHPI) (score 0-5, 0 being no plaque, 5 being entire tooth covered with plaque)
Plaque removal	Day 14 visit	Plaque removal by mechanical treatment with a water-/airpik. The technique will be applied professionally at the clinical site by co-investigator.
Oral microbiome	Change in microbiome composition from baseline to Day 14 follow-up	Oral microbiome composition

Trial Locations

Locations (1)

Aarhus University, Department of Dentistry and Oral Health; 🇩🇰 Aarhus, Denmark