Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals

Dental Plaque Clinical Trial

Official title:

Effect of Enzyme-containing Lozenges on Dental Biofilm Accumulation in Healthy Individuals: A Randomized Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05082103
• Other study ID #: NZ-OHBFC-2021-01
• Status: Terminated
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2022
• 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 enzyme containing lozenges on dental plaque accumulation in healthy adults.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• 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.

• 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

• Dental Plaque

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Denmark	Aarhus University, Department of Dentistry and Oral Health	Aarhus

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	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	Plaque amount	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)	Change in QHPI score from baseline to Day 7 follow-up and from baseline to Day 14 follow-up
Secondary	Gingivitis	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)	Change in GI from baseline to Day 14 follow-up
Secondary	Plaque removal	Plaque removal by mechanical treatment with a water-/airpik. The technique will be applied professionally at the clinical site by co-investigator.	Day 14 visit
Secondary	Oral microbiome	Oral microbiome composition	Change in microbiome composition from baseline to Day 14 follow-up
Secondary	Plaque fluorescence intensity measurement	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.	Change in intensity measurement from baseline to Day 7 follow-up and Day 14 follow-up