White Spot LesionsinfiltrationNCT01881100
Randomized Trial on Resin Infiltration in Deciduous Teeth
A study testing resin infiltration and fluoride varnish in people with White Spot Lesions and Caries, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
It was hypothesized that resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth reduce considerably the progression of treated caries lesions, compared to fluoride varnish therapy only. Read more about this study
- Who is it for?
- Ages 18 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesions, Caries
- What is being tested?
- resin infiltration and fluoride varnish
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2011to Aug 2012
- 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 18 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- at least two active smooth-surface caries lesions in deciduous teeth (ICDAS II code 2)
- a written consent of parents/ guardians for participation in the research study
Who cannot join
- age above 5.9 years
- systematic disease
- cavitated lesions
- enamel defects
- current participation in another study
- a planned change of residence within one year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial on Resin Infiltration Versus Fluoride Varnish Treatment of Early Smooth-surface Caries Lesions in Deciduous Teeth
It was hypothesized that resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth reduce considerably the progression of treated caries lesions, compared to fluoride varnish therapy only.
Read the detailed description
- To determine the number of patients, sample size was based on data from studies assessing fluoride varnish efficacy in children with deciduous teeth (progression of caries reduction by 33 %)(95% CI, from 19 to 48%, P<0.0001); (α = 0.05; power = 80%; chi-square test2). The calculated sample size was 60 children and 120 white spot lesions. The initially planned number of participants was increased by expected 20% drop-out after 1 year, at least 72 children; the minimal number of treated active caries lesions amounted to 144.
- Participants were allocated to the "test" and to the "control" group, respectively, by computer-generated randomly permuted blocks using package blockrand in R statistical software, sealed in envelopes.
- The children were re-examined clinically by the same 2 examiners as at baseline evaluation.
- Statistical analyses were performed using statistical software STATISTICA 10 (StatSoft), 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 was used (for e.g. to compare experimental group with the control one); Wilcoxon signed-rank test was used for paired samples (for e.g. to compare first measurement with final measurement for experimental group). Comparison of fractions was conducted using Pearson's chi-square test of independence and Z test. The 95% confidence intervals were calculated on the basis of normal approximation.
- Conditions
- White Spot Lesions, Caries
- Being tested
- resin infiltration, fluoride varnish
- Keywords
- resin infiltration, randomized clinical trial, fluoride varnish, caries lesion, deciduous teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resin infiltrationOther
Also called Icon DMG Germany, Duraphat Colgate Palmolive Germany
The test group (41 children) had caries lesions treated with the resin infiltration technique using Icon by the following procedure: rubber dam applying; etching with 15% hydrochloric acid for 120 s; surface rinsing and drying; dehydrating with ethanol for 30 s and air-drying; infiltrant resin infiltration with a syringe for 180 s; resin polymerization (polymerized by blue light - wavelength of 450 nm and intensity of 800mW/cm2; resin reapplication for 60 s and polymerization; rubber dam removal, and working on the infiltrated lesion with polishing rubbers. After the procedure fluoride varnish was applied.
fluoride varnishOther
Also called Duraphat Colgate Palmolive, Hamburg, Germany
All tooth surfaces including WSL treated with fluoride varnish (2,26% F, Duraphat ® Colgate Palmolive, Hamburg, Germany).
| Study group | Role | What they receive |
|---|---|---|
| resin infiltration | Experimental | The test group (41 children) had caries lesions treated with the infiltration technique using Icon (DMG, Hamburg, Germany) and fluoride varnish (Duraphat, Colgate Palmolive, Hamburg, Germany)at baseline evaluation. Fluoride varnish was applied every control visit every three months during 1 year. Receives: Other: resin infiltration; Other: fluoride varnish |
| fluoride varnish | Active comparator | The control group (40 children) had all tooth surfaces including WSL treated with fluoride varnish (Duraphat Colgate Palmolive, Hamburg, Germany)only at baseline evaluation and every control visit every three months during 1 year. Receives: Other: fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth versus fluoride varnish therapy only.
The condition of treated white spot lesions (WSL) were scored using the Nyvad et al. system (17): I-WSL (Inactive WSL) - inactive spot lesion, when surface was becoming smooth, hard and glossy; S -WSL (Sound WSL) - invisible spot lesion taking the appearance of healthy enamel with proper translucency level and surface texture. Active enamel lesions and assessment scores 3-6 according to ICDAS II within a year were considered as decayed (D-Enamel/Dental cavity). Treatment was considered successful when lesions did not progress (I-WSL or S-WSL); unsuccessful when lesions remained active and enamel underwent erosion - i.e. caries occurred (D).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Turska Szybka, Medical University of Warsaw
- Investigators
- Dorota Olczak-Kowalczyk, Ass. Prof., Study director, Warsaw Medical University, 61 Żwirki i Wigury St.,02-091WarsawDorota Olczak-Kowalczyk, Ass.Prof., Study director, Warsaw Medical University, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881100
- Sponsor's protocol ID
- No sponsor ID
- Other IDs
- WarsawMU
- Acronym
- infiltration
- Status last verified
- Jun 2013
- First submitted
- 16 Jun 2013
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on Resin Infiltration Versus Fluoride Varnish Treatment of Early Smooth-surface Caries Lesions in Deciduous Teeth
- ClinicalTrials.gov ID
- NCT01881100
- Acronym / sponsor ID
- infiltration / No sponsor ID
- Conditions
- White Spot Lesions, Caries
- Keywords
- resin infiltration, randomized clinical trial, fluoride varnish, caries lesion, deciduous teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Jun 2013 (estimated)
- 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.
It was hypothesized that resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth reduce considerably the progression of treated caries lesions, compared to fluoride varnish therapy only.
Detailed description
- To determine the number of patients, sample size was based on data from studies assessing fluoride varnish efficacy in children with deciduous teeth (progression of caries reduction by 33 %)(95% CI, from 19 to 48%, P<0.0001); (α = 0.05; power = 80%; chi-square test2). The calculated sample size was 60 children and 120 white spot lesions. The initially planned number of participants was increased by expected 20% drop-out after 1 year, at least 72 children; the minimal number of treated active caries lesions amounted to 144.
- Participants were allocated to the "test" and to the "control" group, respectively, by computer-generated randomly permuted blocks using package blockrand in R statistical software, sealed in envelopes.
- The children were re-examined clinically by the same 2 examiners as at baseline evaluation.
- Statistical analyses were performed using statistical software STATISTICA 10 (StatSoft), 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 was used (for e.g. to compare experimental group with the control one); Wilcoxon signed-rank test was used for paired samples (for e.g. to compare first measurement with final measurement for experimental group). Comparison of fractions was conducted using Pearson's chi-square test of independence and Z test. The 95% confidence intervals were calculated on the basis of normal approximation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resin infiltration | Experimental | Other: resin infiltration, Other: fluoride varnishThe test group (41 children) had caries lesions treated with the infiltration technique using Icon (DMG, Hamburg, Germany) and fluoride varnish (Duraphat, Colgate Palmolive, Hamburg, Germany)at baseline evaluation. Fluoride varnish was applied every control visit every three months during 1 year. |
| fluoride varnish | Active comparator | Other: fluoride varnishThe control group (40 children) had all tooth surfaces including WSL treated with fluoride varnish (Duraphat Colgate Palmolive, Hamburg, Germany)only at baseline evaluation and every control visit every three months during 1 year. |
Who may qualify
- Ages
- 18 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- at least two active smooth-surface caries lesions in deciduous teeth (ICDAS II code 2)
- a written consent of parents/ guardians for participation in the research study
Key exclusion criteria (6 listed)
- age above 5.9 years
- systematic disease
- cavitated lesions
- enamel defects
- current participation in another study
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 |
|---|---|---|
| resin infiltrationAlso: Icon DMG Germany, Duraphat Colgate Palmolive GermanyThe test group (41 children) had caries lesions treated with the resin infiltration technique using Icon by the following procedure: rubber dam applying; etching with 15% hydrochloric acid for 120 s; surface rinsing and drying; dehydrating with ethanol for 30 s and air-drying; infiltrant resin infiltration with a syringe for 180 s; resin polymerization (polymerized by blue light - wavelength of 450 nm and intensity of 800mW/cm2; resin reapplication for 60 s and polymerization; rubber dam removal, and working on the infiltrated lesion with polishing rubbers. After the procedure fluoride varnish was applied. | Other | resin infiltration |
| fluoride varnishAlso: Duraphat Colgate Palmolive, Hamburg, GermanyAll tooth surfaces including WSL treated with fluoride varnish (2,26% F, Duraphat ® Colgate Palmolive, Hamburg, Germany). | Other | fluoride varnish, resin infiltration |
Primary outcome
Resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth versus fluoride varnish therapy only.
Time frame: one year
The condition of treated white spot lesions (WSL) were scored using the Nyvad et al. system (17): I-WSL (Inactive WSL) - inactive spot lesion, when surface was becoming smooth, hard and glossy; S -WSL (Sound WSL) - invisible spot lesion taking the appearance of healthy enamel with proper translucency level and surface texture. Active enamel lesions and assessment scores 3-6 according to ICDAS II within a year were considered as decayed (D-Enamel/Dental cavity). Treatment was considered successful when lesions did not progress (I-WSL or S-WSL); unsuccessful when lesions remained active and enamel underwent erosion - i.e. caries occurred (D).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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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, Ass. Prof. study director
Warsaw Medical University, 61 Żwirki i Wigury St.,02-091Warsaw
Dorota Olczak-Kowalczyk, Ass.Prof. study director
Warsaw Medical University, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resin infiltration and fluoride varnish in people with White Spot Lesions and Caries, 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 19 Jun 2013. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth versus fluoride varnish therapy only. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2013.