Orthodontic Appliance ComplicationNCT03725020
Efficacy of a Novel Fluoride Varnish in Preventing WSL During/After Treatment With Fixed Orthodontic Appliances
A study testing Fluoride varnish in people with Orthodontic Appliance Complication, run by Malmö University.
Trial summary
The aim of the present study is to evaluate the efficacy of a novel fluoride varnish (NFV) in preventing white spot lesion development in adolescents during and after treatment with fixed orthodontic appliances. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Fluoride varnish
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 31 Dec 2019
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The inclusion criterion is a scheduled treatment with fixed maxillary appliances according a standard straight-wire concept (McLaughlin et al., 2001) during a period of at least 12 months
Who cannot join
- In the event of long-term prescriptions of general antibiotics during the course of the study, this should be recorded separately
About this study
Official title: Efficacy of a Novel Fluoride Varnish Formula in Preventing White Spot Lesions During and After Treatment With Fixed Orthodontic Appliances
The aim of the present study is to evaluate the efficacy of a novel fluoride varnish (NFV) in preventing white spot lesion development in adolescents during and after treatment with fixed orthodontic appliances.
Read the detailed description
The study will employ a double-blind, randomized placebo-controlled design with two parallel groups. The intervention will start at onset of the fixed appliances and will be finalized one year after debonding. The primary outcome will be incidence of white spot lesions on the labial surfaces of the maxillary incisors, canines and premolars, as assessed from high-resolution digital photos. The secondary outcome is the prevalence of WSLs at debonding.
During the course of the orthodontic treatment, the patients are regularly checked every 6th week. At the end of each such occasion, the clinical staff will apply either the test or the placebo varnish with a small brush in a thin layer around the base of the braces on the maxillary teeth.
The pre- and post-treatment photos are projected on a screen (Hewlett Packard ProBook 6650b, Palo Alto CA, USA) in a dark room and the incidence and severity of enamel demineralization will be registered independently by two experienced and calibrated orthodontists according to the index of Gorelick et al. (1982).
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Fluoride varnish
- Keywords
- Orthodontics, Fixed appliance, White Spot Lesions, Fluoride varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride varnishOther
The study will employ a double-blind, randomized placebo-controlled design with two parallel groups. The intervention will start at onset of the fixed appliances and will be finalized one year after debond. The primary outcome will be incidence of white spot lesions on the labial surfaces of the maxillary incisors, canines and premolars, as assessed from high-resolution digital photos. The secondary outcome is the prevalence of WSLs at debonding.
| Study group | Role | What they receive |
|---|---|---|
| Fluoride varnish | Experimental | During the course of the orthodontic treatment, the patients are regularly checked every 6th week. At the end of each such occasion, the clinical staff will apply the test varnish with a small brush in a thin layer around the base of the braces on the maxillary teeth. The varnish is let to dry and the subjects are instructed not to eat or drink within 60 minutes after the application. The NFV test varnish has mint flavour and the active ingredient is ammonium fluoride dissolved in ethanol, water and an acrylate polymer. Receives: Other: Fluoride varnish |
| Varnish without Fluoride | Placebo comparator | During the course of the orthodontic treatment, the patients are regularly checked every 6th week. At the end of each such occasion, the clinical staff will apply either the placebo varnish with a small brush in a thin layer around the base of the braces on the maxillary teeth. The varnish is let to dry and the subjects are instructed not to eat or drink within 60 minutes after the application. The placebo varnish has an identical composition as the test varnish except for the ammonium fluoride. Thus, taste, colour and handling properties are the same. Receives: Other: Fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be incidence of white spot lesions on the labial surfaces of the maxillary incisors, canines and premolars
Assessed from high-resolution digital photos
Measured: 12-24 months
Secondary outcomes (1)
The secondary outcome is the prevalence of WSLs at debonding and one year after debond
Assessed from high-resolution digital photos
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 Jun 2014
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Appliance ComplicationStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Mikael Sonesson, Malmö University
- Investigators
- Mikael Sonesson, Odont. Dr., Principal investigator, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725020
- Sponsor's protocol ID
- MalmoUSonesson
- Status last verified
- Nov 2018
- First submitted
- 29 Oct 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sonesson M, Brechter A, Lindman R, Abdulraheem S, Twetman S. Fluoride varnish for white spot lesion prevention during orthodontic treatment: results of a randomized controlled trial 1 year after debonding. Eur J Orthod. 2021 Aug 3;43(4):473-477. doi: 10.1093/ejo/cjaa055.
PubMed 33009565Sonesson M, Brechter A, Abdulraheem S, Lindman R, Twetman S. Fluoride varnish for the prevention of white spot lesions during orthodontic treatment with fixed appliances: a randomized controlled trial. Eur J Orthod. 2020 Jun 23;42(3):326-330. doi: 10.1093/ejo/cjz045.
PubMed 31197364
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Novel Fluoride Varnish Formula in Preventing White Spot Lesions During and After Treatment With Fixed Orthodontic Appliances
- ClinicalTrials.gov ID
- NCT03725020
- Acronym / sponsor ID
- MalmoUSonesson
- Conditions
- Orthodontic Appliance Complication
- Keywords
- Orthodontics, Fixed appliance, White Spot Lesions, Fluoride varnish
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 30 Oct 2018 (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.
The aim of the present study is to evaluate the efficacy of a novel fluoride varnish (NFV) in preventing white spot lesion development in adolescents during and after treatment with fixed orthodontic appliances.
Detailed description
The study will employ a double-blind, randomized placebo-controlled design with two parallel groups. The intervention will start at onset of the fixed appliances and will be finalized one year after debonding. The primary outcome will be incidence of white spot lesions on the labial surfaces of the maxillary incisors, canines and premolars, as assessed from high-resolution digital photos. The secondary outcome is the prevalence of WSLs at debonding.
During the course of the orthodontic treatment, the patients are regularly checked every 6th week. At the end of each such occasion, the clinical staff will apply either the test or the placebo varnish with a small brush in a thin layer around the base of the braces on the maxillary teeth.
The pre- and post-treatment photos are projected on a screen (Hewlett Packard ProBook 6650b, Palo Alto CA, USA) in a dark room and the incidence and severity of enamel demineralization will be registered independently by two experienced and calibrated orthodontists according to the index of Gorelick et al. (1982).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoride varnish | Experimental | Other: Fluoride varnishDuring the course of the orthodontic treatment, the patients are regularly checked every 6th week. At the end of each such occasion, the clinical staff will apply the test varnish with a small brush in a thin layer around the base of the braces on the maxillary teeth. The varnish is let to dry and the subjects are instructed not to eat or drink within 60 minutes after the application. The NFV test varnish has mint flavour and the active ingredient is ammonium fluoride dissolved in ethanol, water and an acrylate polymer. |
| Varnish without Fluoride | Placebo comparator | Other: Fluoride varnishDuring the course of the orthodontic treatment, the patients are regularly checked every 6th week. At the end of each such occasion, the clinical staff will apply either the placebo varnish with a small brush in a thin layer around the base of the braces on the maxillary teeth. The varnish is let to dry and the subjects are instructed not to eat or drink within 60 minutes after the application. The placebo varnish has an identical composition as the test varnish except for the ammonium fluoride. Thus, taste, colour and handling properties are the same. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The inclusion criterion is a scheduled treatment with fixed maxillary appliances according a standard straight-wire concept (McLaughlin et al., 2001) during a period of at least 12 months
Key exclusion criteria (1 listed)
- In the event of long-term prescriptions of general antibiotics during the course of the study, this should be recorded separately
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 |
|---|---|---|
| Fluoride varnishThe study will employ a double-blind, randomized placebo-controlled design with two parallel groups. The intervention will start at onset of the fixed appliances and will be finalized one year after debond. The primary outcome will be incidence of white spot lesions on the labial surfaces of the maxillary incisors, canines and premolars, as assessed from high-resolution digital photos. The secondary outcome is the prevalence of WSLs at debonding. | Other | Fluoride varnish, Varnish without Fluoride |
Primary outcome
The primary outcome will be incidence of white spot lesions on the labial surfaces of the maxillary incisors, canines and premolars
Time frame: 12-24 months
Assessed from high-resolution digital photos
1 secondary outcome
The secondary outcome is the prevalence of WSLs at debonding and one year after debond
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Derived from this study: PubMed 33009565Sonesson M, Brechter A, Lindman R, Abdulraheem S, Twetman S. Fluoride varnish for white spot lesion prevention during orthodontic treatment: results of a randomized controlled trial 1 year after debonding. Eur J Orthod. 2021 Aug 3;43(4):473-477. doi: 10.1093/ejo/cjaa055.
- Derived from this study: PubMed 31197364Sonesson M, Brechter A, Abdulraheem S, Lindman R, Twetman S. Fluoride varnish for the prevention of white spot lesions during orthodontic treatment with fixed appliances: a randomized controlled trial. Eur J Orthod. 2020 Jun 23;42(3):326-330. doi: 10.1093/ejo/cjz045.
- Individual participant dataSharing planned: No
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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, Odont. Dr. principal investigator
Malmö University
Questions about this trial
What is this clinical trial studying?
A study testing Fluoride varnish in people with Orthodontic Appliance Complication, run by Malmö University.
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 1 inclusion and 1 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The primary outcome will be incidence of white spot lesions on the labial surfaces of the maxillary incisors, canines and premolars (time frame: 12-24 months). 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 NCT03725020, which also lists 2 linked publications.
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 6 Nov 2018.