Dental CariesPhase 4NCT00723515
Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study
A Phase 4 study testing sodium fluoride and sodium fluoride calcium fluoride in people with Dental Caries, run by University of Pernambuco at 1 site in Brazil.
Trial summary
The study hypothesis is the difference in therapeutic effect of two varnish formulations (G1 = NaF, 2.26%F, G2 = NaF, 2.71% F + CaF2). These products are commercially available in the Brazilian and international market and they are used for dental caries as white spot lesions control. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- sodium fluoride and sodium fluoride calcium fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2007to Oct 2007
- Phase
- Phase 4
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- regular hygiene habits (brushing teeth everyday)
- registered in public schools
Who cannot join
- dental caries such as small cavities or restorations in the target teeth (permanent anterior teeth)
- development enamel alterations (hypoplasia, fluorosis) or periodontal disease
- children using orthodontic devices
- under medical treatment
- taking any kind of medicine
- no informed consent form signed
Trial locations and contacts
1 site in 1 country.
About this study
The study hypothesis is the difference in therapeutic effect of two varnish formulations (G1 = NaF, 2.26%F, G2 = NaF, 2.71% F + CaF2). These products are commercially available in the Brazilian and international market and they are used for dental caries as white spot lesions control.
Read the detailed description
The aim of this study was to evaluate the therapeutic effect of two varnish formulations (G1 = NaF, 2.26%F, G2 = NaF, 2.71% F + CaF2) on the remineralization of white spot lesions (WSL). The sample was composed of 15 (7- to 12-year-old) children with 45 active WSL in anterior permanent teeth. The children were randomly divided in two groups providing 22 lesions for G1 and 23 for G2. The children were submitted to weekly varnish applications 4 times. The WSL were evaluated twice: baseline and on week 4. Maximum lesion dimensions (mesial-distal and incisal-gingival) were measured in millimeters and classified in four grades of size. WSL were also recorded assessing lesion activity by one calibrated examiner. The Pearson chi-square and Fisher's exact tests were used (P < 0.01). WSL reductions were observed in both varnish groups (Chi-square= 0.15, d.f.=1, P=0.90); and with similar magnitude (in mm): 1.19 and 1.29 for G1 and G2, respectively. Thirty-six WLS (15 in G1 and 26 in G2) were classified as inactive in week 4 reaching an overall value of 80%. No difference was observed between G1 and G2 regarding activity scores (Fisher's exact test, p > 0.01). It can be concluded that after 4 applications the two varnish formulations tested produced similar clinical effects indicating the reduction and the control of carious activity in most WSL.
- Conditions
- Dental Caries
- Being tested
- sodium fluoride, sodium fluoride calcium fluoride
- Keywords
- White spot lesion, Tooth remineralization, Fluoride varnishes
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium fluorideDrug
Also called Duraphat®, Colgate Palmolive GmbH, Hamburg, Germany
sodium fluoride 5%
sodium fluoride calcium fluorideDrug
Also called Duofluorid XII®, FGM, Joinville, Brazil
sodium fluoride 5% + calcium fluoride
| Study group | Role | What they receive |
|---|---|---|
| G1 | Active comparator | NaF (sodium fluoride varnish) with 2.26% of fluoride Receives: Drug: sodium fluoride |
| G2 | Experimental | NaF (sodium fluoride)2.71% of fluoride plus CaF2 (calcium fluoride) Receives: Drug: sodium fluoride calcium fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of the size of the caries lesion
Measured: 4 weeks
Secondary outcomes (1)
Inactivation of carious lesions
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startFeb 2007
- Primary completionJun 2007
- Study completionOct 2007
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 Dental 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pernambuco
- Sponsor type
- University, hospital or other
- Investigators
- Jainara MS Ferreira, Master, Principal investigator, University of PernambucoAna Karla R Aragão, Graduate, Study chair, Univeristy of PernambucoAdriana DB Rosa, student, Study chair, Federal University of ParaibaFabio C Sampaio, PhD, Study chair, Federal Univerisity of ParaibaValdenice A Menezes, PhD, Study chair, Univeristy of Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723515
- Sponsor's protocol ID
- UPE 260/08
- Status last verified
- Jul 2008
- First submitted
- 24 Jul 2008
- Last updated
- 28 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferreira JM, Aragao AK, Rosa AD, Sampaio FC, Menezes VA. Therapeutic effect of two fluoride varnishes on white spot lesions: a randomized clinical trial. Braz Oral Res. 2009 Oct-Dec;23(4):446-51. doi: 10.1590/s1806-83242009000400015.
PubMed 20027453
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study
- ClinicalTrials.gov ID
- NCT00723515
- Acronym / sponsor ID
- UPE 260/08
- Conditions
- Dental Caries
- Keywords
- White spot lesion, Tooth remineralization, Fluoride varnishes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PernambucoUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jun 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 28 Jul 2008 (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.
The study hypothesis is the difference in therapeutic effect of two varnish formulations (G1 = NaF, 2.26%F, G2 = NaF, 2.71% F + CaF2). These products are commercially available in the Brazilian and international market and they are used for dental caries as white spot lesions control.
Detailed description
The aim of this study was to evaluate the therapeutic effect of two varnish formulations (G1 = NaF, 2.26%F, G2 = NaF, 2.71% F + CaF2) on the remineralization of white spot lesions (WSL). The sample was composed of 15 (7- to 12-year-old) children with 45 active WSL in anterior permanent teeth. The children were randomly divided in two groups providing 22 lesions for G1 and 23 for G2. The children were submitted to weekly varnish applications 4 times. The WSL were evaluated twice: baseline and on week 4. Maximum lesion dimensions (mesial-distal and incisal-gingival) were measured in millimeters and classified in four grades of size. WSL were also recorded assessing lesion activity by one calibrated examiner. The Pearson chi-square and Fisher's exact tests were used (P < 0.01). WSL reductions were observed in both varnish groups (Chi-square= 0.15, d.f.=1, P=0.90); and with similar magnitude (in mm): 1.19 and 1.29 for G1 and G2, respectively. Thirty-six WLS (15 in G1 and 26 in G2) were classified as inactive in week 4 reaching an overall value of 80%. No difference was observed between G1 and G2 regarding activity scores (Fisher's exact test, p > 0.01). It can be concluded that after 4 applications the two varnish formulations tested produced similar clinical effects indicating the reduction and the control of carious activity in most WSL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G1 | Active comparator | Drug: sodium fluorideNaF (sodium fluoride varnish) with 2.26% of fluoride |
| G2 | Experimental | Drug: sodium fluoride calcium fluorideNaF (sodium fluoride)2.71% of fluoride plus CaF2 (calcium fluoride) |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- regular hygiene habits (brushing teeth everyday)
- registered in public schools
Key exclusion criteria (6 listed)
- dental caries such as small cavities or restorations in the target teeth (permanent anterior teeth)
- development enamel alterations (hypoplasia, fluorosis) or periodontal disease
- children using orthodontic devices
- under medical treatment
- taking any kind of medicine
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 |
|---|---|---|
| sodium fluorideAlso: Duraphat®, Colgate Palmolive GmbH, Hamburg, Germanysodium fluoride 5% | Drug | G1 |
| sodium fluoride calcium fluorideAlso: Duofluorid XII®, FGM, Joinville, Brazilsodium fluoride 5% + calcium fluoride | Drug | G2 |
Primary outcome
reduction of the size of the caries lesion
Time frame: 4 weeks
1 secondary outcome
Inactivation of carious lesions
Time frame: 4 weeks
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 28 Jul 2008.
- Derived from this study: PubMed 20027453Ferreira JM, Aragao AK, Rosa AD, Sampaio FC, Menezes VA. Therapeutic effect of two fluoride varnishes on white spot lesions: a randomized clinical trial. Braz Oral Res. 2009 Oct-Dec;23(4):446-51. doi: 10.1590/s1806-83242009000400015.
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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.
Jainara MS Ferreira, Master principal investigator
University of Pernambuco
Ana Karla R Aragão, Graduate study chair
Univeristy of Pernambuco
Adriana DB Rosa, student study chair
Federal University of Paraiba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sodium fluoride and sodium fluoride calcium fluoride in people with Dental Caries, run by University of Pernambuco at 1 site in Brazil.
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 28 Jul 2008. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
reduction of the size of the caries lesion (time frame: 4 weeks). 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 NCT00723515, 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 28 Jul 2008.