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

Gingivitis Clinical Trial

Official title:

Preventive Effect of an Enzyme-containing Lozenge on Dental Biofilm Accumulation in Healthy Individuals: A Clinical Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05070507
• Other study ID #: NZ-OHBFC-2020-04
• Status: Completed
• Phase: N/A
• Start date: January 8, 2021
• Est. completion date: May 10, 2021

Study information

• Verified date: October 2021
• Source: Novozymes A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 10, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Dental Plaque
• Gingivitis
• Infections
• Microbial Colonization

Intervention

Dietary Supplement:
• Enzyme containing lozenge
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
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.

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
Novozymes A/S	University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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