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

Not Applicable

Completed

• Conditions: Microbial Colonization; Dental Plaque; Gingivitis
• Interventions: Dietary Supplement: Enzyme containing lozenge; Dietary Supplement: Placebo lozenge

• Registration Number: NCT05070507
• Lead Sponsor: Novozymes A/S

Brief Summary

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

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 Timeline

• Study Start: 2021-01-08
• Primary Completion: 2021-02-26
• Study Completion: 2021-05-10
• Study First Submitted: 2021-09-12
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-05
• Last Update Submitted: 2021-10-05
• Study First Posted: 2021-10-07
• Last Update Posted: 2021-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enzyme containing lozenge	Enzyme containing lozenge	-
Placebo lozenge	Placebo lozenge	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aarhus University; 🇩🇰 Aarhus C, Denmark