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Effect of Enzyme-containing Mouth Rinse on Dental Biofilm in Patients With Fixed Orthodontic Appliances

NCT05033015 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-09-10

No results posted yet for this study

Summary

Caries is a biofilm-mediated global public health problem causing health, social and economic consequences for individuals, communities and countries.

Treatment with fixed orthodontic appliances is associated with impaired oral hygiene. This results in a demineralization of the enamel (white spot lesions). The prevalence is fairly high (30-50%) among adolescents and self-applied fluorides cannot completely prevent such lesions. It is therefore important to investigate novel approaches to combat these unwanted adverse effects. A systematic review has suggested that mouthwashes may be suitable technology to control biofilm accumulation in orthodontic patients. The aim of the present pilot study is to evaluate the effect of a novel mouth rinse containing a blend of natural enzymes in addition to fluoride on the presence of oral biofilm in patients undergoing treatment with fixed orthodontic appliances.

Conditions

  • Caries

Interventions

PROCEDURE

Mouth rinse

To test a novel mouth rinse containing enzymes to prevent development of WSL with a control

Sponsors & Collaborators

  • Novozymes A/S

    collaborator INDUSTRY

  • Malmö University

    lead OTHER

Principal Investigators

  • Mikael Sonesson, Assoc Prof. · Malmö University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-08-01
Completion
2021-12-07

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05033015 on ClinicalTrials.gov