NCT05033015

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2021

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

August 27, 2021

Last Update Submit

September 2, 2021

Conditions

Caries

Outcome Measures

Primary Outcomes (1)

  • dental biofilm in test and control

    clinical scoring according to Orthodontic Plaque Index, of the amount and extension of the dental biofilm at baseline and after 7 days. Score 0 no extension Score 5 extended biofilm

    7 days

Secondary Outcomes (1)

  • composition of the salivary microbiome

    7 days

Study Arms (2)

Test

EXPERIMENTAL

Mouth rinse containing enzymes

Procedure: Mouth rinse

Placebo

ACTIVE COMPARATOR

Control, same content as test, without enzymes

Procedure: Mouth rinse

Interventions

Mouth rinsePROCEDURE

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

PlaceboTest

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with fixed orthodontic appliances in at least one arch for at least 3-6 months,
  • visible plaque around the bracket bases of at least 6 teeth
  • repeated oral hygiene instructions have been given during the orthodontic treatment

You may not qualify if:

  • 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, including allergy against enzymes
  • history of common food allergies, such as peanuts, tree nuts, milk, eggs, shellfish, fish, wheat, soybeans
  • self-reported serious medical conditions, pregnancy or nursing
  • acute sinusitis or severe oral-pharyngeal infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mikael Sonesson

Malmo, Skåne County, 20506, Sweden

Location

Related Publications (1)

  • Hoffstedt T, Skov Hansen LB, Twetman S, Sonesson M. Effect of an enzyme-containing mouthwash on the dental biofilm and salivary microbiome in patients with fixed orthodontic appliances: a randomized placebo-controlled pilot trial. Eur J Orthod. 2023 Feb 10;45(1):96-102. doi: 10.1093/ejo/cjac062.

    PMID: 36214729DERIVED

MeSH Terms

Interventions

Mouthwashes

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesCosmeticsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Mikael Sonesson, Assoc Prof.

    Malmö University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Self applied
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 2, 2021

Study Start

March 1, 2021

Primary Completion

August 1, 2021

Study Completion

December 7, 2021

Last Updated

September 10, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)