CariesNCT05033015
Effect of Enzyme-containing Mouth Rinse on Dental Biofilm in Patients With Fixed Orthodontic Appliances
A study testing Mouth rinse in people with Caries, run by Malmö University at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- Mouth rinse
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2021to 7 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Enzyme-containing Mouth Rinse on Dental Biofilm Accumulation in Patients With Fixed Orthodontic Appliances: a Randomized Placebo-controlled Clinical Trial
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.
Read the detailed description
Study design A randomized, double-blind placebo-controlled design with two parallel groups will be performed. The null hypothesis is that the effect on the dental biofilm of the experimental mouth rinse will not differ from that of a placebo rinse without active enzymes.
Patients Adolescent patients (14-18 years) attending the Orthodontic specialist clinic in Karlshamn, Sweden will be invited.
Methods The patients are randomly allocated to the test group or the control group with aid of computer-generated random number. After the baseline clinical registration, the participants are instructed to thoroughly rinse their mouth by swishing the mouth rinse around the teeth twice daily (morning and evening) for 30 seconds. 10 mL of the assigned solution should be used at each occasion. After rinsing, the subjects should spit out but no additional rinsing with water is allowed afterwards. The duration of the intervention is one week and the patients are instructed to brush their teeth twice daily using a 1,450 ppm fluoride toothpaste. The test and the placebo mouth rinses should be separated from the daily tooth brushing with at least 30 minutes. The patients are provided with a standardized enzyme-free toothpaste to be used during the intervention.
Intervention The water-based test rinse contains a blend of enzymes in an aqueous solution. The safety evaluation of the three enzymes is tested. The control (placebo) rinse has an identical taste, color and texture but contains no enzymes. The solutions are provided in color-coded tubes, each containing exactly 10 mL of the test or placebo mouth rinse. An independent monitor based at Malmö University but not involved in the project will guarantee the allocation concealment.
Statistical methods All clinical data are processed with the IBM-SPSS software (version 25.0, Chicago, USA). Descriptive analyses will be performed with continuous and categorical data. Differences between and within the groups are compared with unpaired and paired tests, respectively. A p-value less than 0.05 is regarded as statistically significant. The statistical calculations are completed before the group allocation is unveiled.
Power calculation There are no previous clinical data available on the biofilm response to the experimental mouth rinse and this pilot study will form the basis of future sample-size calculations. A mean difference of 0.5 units (SD 0.4) is considered as clinically meaningful and an estimation based on α=0.05 and β=0.8 indicate that 20 patients in each group needs to be enrolled to the pilot project.
- Conditions
- Caries
- Being tested
- Mouth rinse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouth rinseProcedure or surgery
To test a novel mouth rinse containing enzymes to prevent development of WSL with a control
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Mouth rinse containing enzymes Receives: Procedure: Mouth rinse |
| Placebo | Active comparator | Control, same content as test, without enzymes Receives: Procedure: Mouth rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (1)
composition of the salivary microbiome
DNA-extraction and whole genome sequencing will be conducted when all samples are collected. The DNA-extraction will be performed with Macherey-Nagel™ NucleoSpin™ Soil kit. The V3-V4 region of 16S will be PCR amplified using universal primers and sequenced using Illumina MiSeq 300bp paired end.
DNA-extraction and whole genome sequencing will be conducted when all samples are collected. The DNA-extraction will be performed with Macherey-Nagel™ NucleoSpin™ Soil kit. The V3-V4 region of 16S will be PCR amplified using universal primers and sequenced using Illumina MiSeq 300bp paired end.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Mar 2021
- Primary completion1 Aug 2021
- Study completion7 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Collaborators
- Novozymes A/S
- Responsible party
- Principal investigator, Mikael Sonesson, Malmö University
- Investigators
- Mikael Sonesson, Assoc Prof., Principal investigator, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033015
- Sponsor's protocol ID
- 2020-05221
- Status last verified
- Sep 2021
- First submitted
- 27 Aug 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36214729
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Enzyme-containing Mouth Rinse on Dental Biofilm Accumulation in Patients With Fixed Orthodontic Appliances: a Randomized Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05033015
- Acronym / sponsor ID
- 2020-05221
- Conditions
- Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Collaborators
- Novozymes A/S
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 7 Dec 2021 (estimated)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design A randomized, double-blind placebo-controlled design with two parallel groups will be performed. The null hypothesis is that the effect on the dental biofilm of the experimental mouth rinse will not differ from that of a placebo rinse without active enzymes.
Patients Adolescent patients (14-18 years) attending the Orthodontic specialist clinic in Karlshamn, Sweden will be invited.
Methods The patients are randomly allocated to the test group or the control group with aid of computer-generated random number. After the baseline clinical registration, the participants are instructed to thoroughly rinse their mouth by swishing the mouth rinse around the teeth twice daily (morning and evening) for 30 seconds. 10 mL of the assigned solution should be used at each occasion. After rinsing, the subjects should spit out but no additional rinsing with water is allowed afterwards. The duration of the intervention is one week and the patients are instructed to brush their teeth twice daily using a 1,450 ppm fluoride toothpaste. The test and the placebo mouth rinses should be separated from the daily tooth brushing with at least 30 minutes. The patients are provided with a standardized enzyme-free toothpaste to be used during the intervention.
Intervention The water-based test rinse contains a blend of enzymes in an aqueous solution. The safety evaluation of the three enzymes is tested. The control (placebo) rinse has an identical taste, color and texture but contains no enzymes. The solutions are provided in color-coded tubes, each containing exactly 10 mL of the test or placebo mouth rinse. An independent monitor based at Malmö University but not involved in the project will guarantee the allocation concealment.
Statistical methods All clinical data are processed with the IBM-SPSS software (version 25.0, Chicago, USA). Descriptive analyses will be performed with continuous and categorical data. Differences between and within the groups are compared with unpaired and paired tests, respectively. A p-value less than 0.05 is regarded as statistically significant. The statistical calculations are completed before the group allocation is unveiled.
Power calculation There are no previous clinical data available on the biofilm response to the experimental mouth rinse and this pilot study will form the basis of future sample-size calculations. A mean difference of 0.5 units (SD 0.4) is considered as clinically meaningful and an estimation based on α=0.05 and β=0.8 indicate that 20 patients in each group needs to be enrolled to the pilot project.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Procedure: Mouth rinseMouth rinse containing enzymes |
| Placebo | Active comparator | Procedure: Mouth rinseControl, same content as test, without enzymes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mouth rinseTo test a novel mouth rinse containing enzymes to prevent development of WSL with a control | Procedure or surgery | Placebo, Test |
Primary outcome
dental biofilm in test and control
Time frame: 7 days
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
1 secondary outcome
composition of the salivary microbiome
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Derived from this study: PubMed 36214729Hoffstedt 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.
- Individual participant dataSharing planned: No
Related trials for Caries
Active, not recruiting
Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities
Caries, Defective Restorations
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruitingObservational study
Diagnostic Performance of Ai vs Junior Dentists
Diagnosis
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikael Sonesson, Assoc Prof. principal investigator
Malmö University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouth rinse in people with Caries, run by Malmö University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dental biofilm in test and control (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05033015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.