Dental CariesNCT03720379
Efficacy of Fluor Protector S in the Prevention in Adolescents
A study testing Fluor Protector S in people with Dental Caries and Fluor, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Purpose of the study is to evaluate the effectiveness of Fluor Protector S in preventing tooth decay in adolescents and to isolate factors that reduce its effectiveness. In this study, half of the randomly assigned participants will received fluoride varnish (Fluor Protector S) and will be considered an intervention… Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Fluor
- What is being tested?
- Fluor Protector S
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 sitePoland
- Study dates
- 19 Oct 2018to May 2020
- 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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age> 12 ≤ 19 years
- All permanent teeth (except the third molar teeth)
- Restored caries lesions
- Teeth with International Caries Detection and Assessment System II score 0, 1, or 2
- Agreement of parents / legal guardians and patients to participate in the study
Who cannot join
- Planned change of residence during the year
- Chronic illness or medication that increases the risk of tooth decay
- Orthodontic treatment
- Caries lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Fluor Protector S in the Prevention of Tooth Decay in Adolescents
Purpose of the study is to evaluate the effectiveness of Fluor Protector S in preventing tooth decay in adolescents and to isolate factors that reduce its effectiveness.
In this study, half of the randomly assigned participants will received fluoride varnish (Fluor Protector S) and will be considered an intervention group. The other half will undergo placebo application.
Read the detailed description
Evidence from 6 systematic reviews involving 200 trials and more than 80,000 participants further supports the effectiveness of fluoride varnishes, applied professionally 2-4 times a year, for preventing dental caries. Additionally, the simultaneous use of fluoride varnishes with fluoride toothpaste appears to significantly enhance the caries-inhibiting effect compared with the use of fluoride toothpaste alone. The relative benefit of fluoride varnishes application seems to occur irrespective of baseline caries risk, baseline caries severity, background exposure to fluorides and application features such as prior prophylaxis, concentration of fluoride or frequency of application.
To determine the sample size, the results of epidemiological studies conducted in the framework of the health monitoring of the Polish population in 2015 in the group of people aged 15 years (dmf = 5.75) and in 2016 in the group of people aged 12 years (dmf = 3) 0.7 as annual growth of caries, and literature data on the effectiveness of fluoride varnish in the prevention of permanent tooth decay in the general population at 43% (a reduction of about 0.3% per year in dmf, Standard Deviation = 0.8) and was considered achievable in the case Apply Fluor Protector S at 3 months intervals in the high risk group of caries. Size of the study group with such assumptions (α = 0,05, power = 80%, mean reduction of dmf: 0,3, Standard Deviation = 0,8 ; t test for comparison of two groups) - Minimum 84 patients [70 patients+ 20% (dropped out), in both groups].
Participants will be allocated to the "test" and to the "control" group, respectively, by computer-generated randomly permuted blocks using R package in statistical software..
- The children will be examined and re-examined clinically by the same examiners.
- Statistical analyses will be performed using statistical software, the level of significance was set at 0.05. Intra-examiner reliability was assessed by kappa statistics.
- To compare average values between two independent groups U Mann-Whitney test will be used (for e.g. to compare experimental group with the control one); Wilcoxon signed-rank test will be used for paired samples (for e.g. to compare first measurement with final measurement for experimental group). Comparison of fractions will be conducted using Pearson's chi-square test of independence and Z test. The 95% confidence intervals will be calculated on the basis of normal approximation.
Purpose of the study is to evaluate the effectiveness of Fluor Protector S in preventing tooth decay in adolescents and to isolate factors that reduce its effectiveness.
- Conditions
- Dental Caries, Fluor
- Being tested
- Fluor Protector S, Placebo
- Keywords
- fluoride varnish, dental caries, ADOLESCENTS
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluor Protector SDevice
. All of the elements of a clinical trial and the varnish applications will be performed every three-month during one year: Changes in The Simplified Oral Hygiene Index (OHl-S), white spot carious lesion discovered at the initial assessment as invisible, visible and inactive, active, cavities), dmft and dmfs and their components, bite-wings and Diagnodent assessment will be scored at follow-up examinations.
PlaceboDevice
All of the elements of a clinical trial and the placebo applications will be performed every three-month during one year: Changes in The Simplified Oral Hygiene Index (OHl-S), white spot carious lesion discovered at the initial assessment as invisible, visible and inactive, active, cavities), dmft and dmfs and their components, bite-wings and Diagnodent assessment will be scored at follow-up examinations.
| Study group | Role | What they receive |
|---|---|---|
| Fluoride Varnish - Fluor PROTECTOR S | Active comparator | Fluor Protector S - manufacturer: Ivoclar Vivadent Composition: ethanol, water, polymer, saccharin, mint flavor, 1.5% ammonium fluoride (7700 ppm fluoride), additional ingredients
APPLICATION OF Fluor Protector S will be performed AT BASELINE, after 3,6 months (control 1) and after 9 and 12 months (control 2). Preliminary(AT BASELINE) and control dental exams after 12 months will include an interview and a physical examination, radiological and Diagnodent examination, a 6 months follow-up -a physical examination, Diagnodent examination and interview. Receives: Device: Fluor Protector S |
| PLACEBO | Placebo comparator | - Placebo - manufacturer: Ivoclar Vivadent Composition: ethanol, water, polymer, saccharin, mint flavor.
APPLICATION OF PLACEBO will be performed AT BASELINE, after 3,6 months (control 1) and after 9 AND 12 months (control 2). Preliminary(AT BASELINE) and control dental exams after 12 months will include an interview and a physical examination, radiological and Diagnodent examination, a 6 months follow-up -a physical examination, Diagnodent examination and interview. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and intensity of dental caries
The decrease of caries, which means a lower caries occurrence and intensity (lower caries index dmft/dmfs) when comparing to the placebo group.
Diagnodent assessment scale similar at baseline and at the end of the study. The same number of teeth/surfaces with no caries in the fluoride varnish group when comparing to the placebo group, according to scale:
0-14 No caries 15-20 Enamel caries 21-99 Dentinal caries
In the study, bite-wing images are planned at 12 months intervals. The scale will be used to evaluate:
E1 - carious lesion including <1/2 enamel, E2 - carious lesion including> 1/2 enamel, D1 - tooth decay in dentin, not exceeding 1/3 of dentin, D2 - caries in the middle 1/3 of dentin, D3 carious lesion > 2/3 of dentin. Codes E1 and E2 will be recorded as pre-cavity, codes ≥ D1 as cavity. Primary outcome is no signs of caries during radiological examination in fluoride varnish group when comparing to the placebo group.
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 posted25 Oct 2018
- Study start19 Oct 2018
- Primary completionJan 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Model description
- We plan to include 168 subjects in this study. 1. Dental examination Qualified for the study will receive oral and written information on the causative factors of dental caries, hygienic and dietary recommendations. 2. Oral hygiene instruction will be provided. 3. Caries risk assesment 4. Application Fluor Protector S or Placebo Dental examination will be performed before the intervention (preliminary), after 6 months and after 12 months. Dental exams will include an interview, a physical examination , radiological examination (bite- wing x-ray images) and Diagnodent assessment. The applications of Fluor Protector S (intervention A) or placebo (intervention B) will be performed every three months during one year.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Ivoclar Vivadent AG, Wroclaw Medical University
- Responsible party
- Sponsor
- Investigators
- Dorota Olczak Kowalczyk, PROFESSOR, Study director, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720379
- Sponsor's protocol ID
- KB/226/2017
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2018
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lenzi TL, Montagner AF, Soares FZ, de Oliveira Rocha R. Are topical fluorides effective for treating incipient carious lesions?: A systematic review and meta-analysis. J Am Dent Assoc. 2016 Feb;147(2):84-91.e1. doi: 10.1016/j.adaj.2015.06.018. Epub 2015 Nov 6.
PubMed 26562737Bansal A, Ingle NA, Kaur N, Ingle E. Recent advancements in fluoride: A systematic review. J Int Soc Prev Community Dent. 2015 Sep-Oct;5(5):341-6. doi: 10.4103/2231-0762.165927.
PubMed 26539383Weyant RJ, Tracy SL, Anselmo TT, Beltran-Aguilar ED, Donly KJ, Frese WA, Hujoel PP, Iafolla T, Kohn W, Kumar J, Levy SM, Tinanoff N, Wright JT, Zero D, Aravamudhan K, Frantsve-Hawley J, Meyer DM; American Dental Association Council on Scientific Affairs Expert Panel on Topical Fluoride Caries Preventive Agents. Topical fluoride for caries prevention: executive summary of the updated clinical recommendations and supporting systematic review. J Am Dent Assoc. 2013 Nov;144(11):1279-91. doi: 10.14219/jada.archive.2013.0057.
PubMed 24177407Richards D. Substantial reduction in caries from regular fluoride varnish application. Evid Based Dent. 2013 Sep;14(3):72-3. doi: 10.1038/sj.ebd.6400947.
PubMed 24071672Gao SS, Zhang S, Mei ML, Lo EC, Chu CH. Caries remineralisation and arresting effect in children by professionally applied fluoride treatment - a systematic review. BMC Oral Health. 2016 Feb 1;16:12. doi: 10.1186/s12903-016-0171-6.
PubMed 26831727Marinho VC, Worthington HV, Walsh T, Clarkson JE. Fluoride varnishes for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD002279. doi: 10.1002/14651858.CD002279.pub2.
PubMed 23846772
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fluor Protector S in the Prevention of Tooth Decay in Adolescents
- ClinicalTrials.gov ID
- NCT03720379
- Acronym / sponsor ID
- KB/226/2017
- Conditions
- Dental Caries, Fluor
- Keywords
- fluoride varnish, dental caries, ADOLESCENTS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Ivoclar Vivadent AG, Wroclaw Medical University
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 25 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.
Purpose of the study is to evaluate the effectiveness of Fluor Protector S in preventing tooth decay in adolescents and to isolate factors that reduce its effectiveness.
In this study, half of the randomly assigned participants will received fluoride varnish (Fluor Protector S) and will be considered an intervention group. The other half will undergo placebo application.
Detailed description
Evidence from 6 systematic reviews involving 200 trials and more than 80,000 participants further supports the effectiveness of fluoride varnishes, applied professionally 2-4 times a year, for preventing dental caries. Additionally, the simultaneous use of fluoride varnishes with fluoride toothpaste appears to significantly enhance the caries-inhibiting effect compared with the use of fluoride toothpaste alone. The relative benefit of fluoride varnishes application seems to occur irrespective of baseline caries risk, baseline caries severity, background exposure to fluorides and application features such as prior prophylaxis, concentration of fluoride or frequency of application.
To determine the sample size, the results of epidemiological studies conducted in the framework of the health monitoring of the Polish population in 2015 in the group of people aged 15 years (dmf = 5.75) and in 2016 in the group of people aged 12 years (dmf = 3) 0.7 as annual growth of caries, and literature data on the effectiveness of fluoride varnish in the prevention of permanent tooth decay in the general population at 43% (a reduction of about 0.3% per year in dmf, Standard Deviation = 0.8) and was considered achievable in the case Apply Fluor Protector S at 3 months intervals in the high risk group of caries. Size of the study group with such assumptions (α = 0,05, power = 80%, mean reduction of dmf: 0,3, Standard Deviation = 0,8 ; t test for comparison of two groups) - Minimum 84 patients [70 patients+ 20% (dropped out), in both groups].
Participants will be allocated to the "test" and to the "control" group, respectively, by computer-generated randomly permuted blocks using R package in statistical software..
- The children will be examined and re-examined clinically by the same examiners.
- Statistical analyses will be performed using statistical software, the level of significance was set at 0.05. Intra-examiner reliability was assessed by kappa statistics.
- To compare average values between two independent groups U Mann-Whitney test will be used (for e.g. to compare experimental group with the control one); Wilcoxon signed-rank test will be used for paired samples (for e.g. to compare first measurement with final measurement for experimental group). Comparison of fractions will be conducted using Pearson's chi-square test of independence and Z test. The 95% confidence intervals will be calculated on the basis of normal approximation.
Purpose of the study is to evaluate the effectiveness of Fluor Protector S in preventing tooth decay in adolescents and to isolate factors that reduce its effectiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We plan to include 168 subjects in this study. 1. Dental examination Qualified for the study will receive oral and written information on the causative factors of dental caries, hygienic and dietary recommendations. 2. Oral hygiene instruction will be provided. 3. Caries risk assesment 4. Application Fluor Protector S or Placebo Dental examination will be performed before the intervention (preliminary), after 6 months and after 12 months. Dental exams will include an interview, a physical examination , radiological examination (bite- wing x-ray images) and Diagnodent assessment. The applications of Fluor Protector S (intervention A) or placebo (intervention B) will be performed every three months during one year.
| Arm | Type | Receives |
|---|---|---|
| Fluoride Varnish - Fluor PROTECTOR S | Active comparator | Device: Fluor Protector SFluor Protector S - manufacturer: Ivoclar Vivadent Composition: ethanol, water, polymer, saccharin, mint flavor, 1.5% ammonium fluoride (7700 ppm fluoride), additional ingredients APPLICATION OF Fluor Protector S will be performed AT BASELINE, after 3,6 months (control 1) and after 9 and 12 months (control 2). Preliminary(AT BASELINE) and control dental exams after 12 months will include an interview and a physical examination, radiological and Diagnodent examination, a 6 months follow-up -a physical examination, Diagnodent examination and interview. |
| PLACEBO | Placebo comparator | Device: Placebo- Placebo - manufacturer: Ivoclar Vivadent Composition: ethanol, water, polymer, saccharin, mint flavor. APPLICATION OF PLACEBO will be performed AT BASELINE, after 3,6 months (control 1) and after 9 AND 12 months (control 2). Preliminary(AT BASELINE) and control dental exams after 12 months will include an interview and a physical examination, radiological and Diagnodent examination, a 6 months follow-up -a physical examination, Diagnodent examination and interview. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age> 12 ≤ 19 years
- All permanent teeth (except the third molar teeth)
- Restored caries lesions
- Teeth with International Caries Detection and Assessment System II score 0, 1, or 2
- Agreement of parents / legal guardians and patients to participate in the study
Key exclusion criteria (4 listed)
- Planned change of residence during the year
- Chronic illness or medication that increases the risk of tooth decay
- Orthodontic treatment
- Caries lesions
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 |
|---|---|---|
| Fluor Protector S. All of the elements of a clinical trial and the varnish applications will be performed every three-month during one year: Changes in The Simplified Oral Hygiene Index (OHl-S), white spot carious lesion discovered at the initial assessment as invisible, visible and inactive, active, cavities), dmft and dmfs and their components, bite-wings and Diagnodent assessment will be scored at follow-up examinations. | Device | Fluoride Varnish - Fluor PROTECTOR S |
| PlaceboAll of the elements of a clinical trial and the placebo applications will be performed every three-month during one year: Changes in The Simplified Oral Hygiene Index (OHl-S), white spot carious lesion discovered at the initial assessment as invisible, visible and inactive, active, cavities), dmft and dmfs and their components, bite-wings and Diagnodent assessment will be scored at follow-up examinations. | Device | PLACEBO |
Primary outcome
Occurrence and intensity of dental caries
Time frame: 12 months
The decrease of caries, which means a lower caries occurrence and intensity (lower caries index dmft/dmfs) when comparing to the placebo group. Diagnodent assessment scale similar at baseline and at the end of the study. The same number of teeth/surfaces with no caries in the fluoride varnish group when comparing to the placebo group, according to scale: 0-14 No caries 15-20 Enamel caries 21-99 Dentinal caries In the study, bite-wing images are planned at 12 months intervals. The scale will be used to evaluate: E1 - carious lesion including <1/2 enamel, E2 - carious lesion including> 1/2 enamel, D1 - tooth decay in dentin, not exceeding 1/3 of dentin, D2 - caries in the middle 1/3 of dentin, D3 carious lesion > 2/3 of dentin. Codes E1 and E2 will be recorded as pre-cavity, codes ≥ D1 as cavity. Primary outcome is no signs of caries during radiological examination in fluoride varnish group when comparing to the placebo group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Background: PubMed 26562737Lenzi TL, Montagner AF, Soares FZ, de Oliveira Rocha R. Are topical fluorides effective for treating incipient carious lesions?: A systematic review and meta-analysis. J Am Dent Assoc. 2016 Feb;147(2):84-91.e1. doi: 10.1016/j.adaj.2015.06.018. Epub 2015 Nov 6.
- Background: PubMed 26539383Bansal A, Ingle NA, Kaur N, Ingle E. Recent advancements in fluoride: A systematic review. J Int Soc Prev Community Dent. 2015 Sep-Oct;5(5):341-6. doi: 10.4103/2231-0762.165927.
- Background: PubMed 24177407Weyant RJ, Tracy SL, Anselmo TT, Beltran-Aguilar ED, Donly KJ, Frese WA, Hujoel PP, Iafolla T, Kohn W, Kumar J, Levy SM, Tinanoff N, Wright JT, Zero D, Aravamudhan K, Frantsve-Hawley J, Meyer DM; American Dental Association Council on Scientific Affairs Expert Panel on Topical Fluoride Caries Preventive Agents. Topical fluoride for caries prevention: executive summary of the updated clinical recommendations and supporting systematic review. J Am Dent Assoc. 2013 Nov;144(11):1279-91. doi: 10.14219/jada.archive.2013.0057.
- Background: PubMed 24071672Richards D. Substantial reduction in caries from regular fluoride varnish application. Evid Based Dent. 2013 Sep;14(3):72-3. doi: 10.1038/sj.ebd.6400947.
- Background: PubMed 26831727Gao SS, Zhang S, Mei ML, Lo EC, Chu CH. Caries remineralisation and arresting effect in children by professionally applied fluoride treatment - a systematic review. BMC Oral Health. 2016 Feb 1;16:12. doi: 10.1186/s12903-016-0171-6.
- Background: PubMed 23846772Marinho VC, Worthington HV, Walsh T, Clarkson JE. Fluoride varnishes for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD002279. doi: 10.1002/14651858.CD002279.pub2.
- 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.
Dorota Olczak Kowalczyk, PROFESSOR study director
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluor Protector S in people with Dental Caries and Fluor, run by Medical University of Warsaw at 1 site in Poland.
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 5 inclusion and 4 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 27 Jun 2019. 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 Poland. 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. 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?
Occurrence and intensity of dental caries (time frame: 12 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 NCT03720379, which also lists 6 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 27 Jun 2019.