Dental CariesNCT01508611
Cost-efficacy of Silver Diammine Fluoride in Erupting Molars
A study testing 30% silver diammine fluoride and Oral hygiene in people with Dental Caries, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study aims to evaluate the cost-effectiveness of 30% silver diammine fluoride in the treatment of clinically caries lesions in enamel, on occlusal surfaces in first permanent molars compared to a control group that performs only the cross-toothbrushing technique and evaluate the acceptability and satisfaction of… Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- 30% silver diammine fluoride and Oral hygiene
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Aug 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- erupting permanent molars (that are not in full occlusion)
- not special children
- children who present at least occlusal surface with initial caries lesion (ICDAS 1, 2, 3)
Who cannot join
- presence of cavitated caries lesions
- presence of enamel defects (hypoplasias)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cost-efficacy of Silver Diammine Fluoride to Control Caries Lesions in Erupting Permanent First Molars - Randomized Clinical Trial.
This study aims to evaluate the cost-effectiveness of 30% silver diammine fluoride in the treatment of clinically caries lesions in enamel, on occlusal surfaces in first permanent molars compared to a control group that performs only the cross-toothbrushing technique and evaluate the acceptability and satisfaction of patients and responsible for the application of the solution cariostatic.
Read the detailed description
The sample will be comprised of 183 patients between 4 to 7 year-old, who present at least occlusal surface with initial caries lesion (ICDAS 1, 2, 3). Patients will be randomly allocated to treatments, according to the technique to be employed: (I) 30% diamine silver fluoride, (II) cross-toothbrushing technique. Will also be guided and motivated individual, where these children will be taught the technique of brushing conventional. It will be given to all patients a toothbrush. In times of reassessment, the degree of wear of the bristles of these brushes will be evaluated in order to infer the use of the same. The teeth will be evaluated by clinical and exams at baseline and after 3, 6, 12, 18 and 24 months.
- Conditions
- Dental Caries
- Being tested
- 30% silver diammine fluoride, Oral hygiene
- Keywords
- dental caries, permanent teeth, silver diamine fluoride, tooth eruption
- Medical subject headings
- Dental Caries, Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30% silver diammine fluorideOther
Also called Cariestop, Biodinamica
The 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied with a disposable microbrush for 3m. Then the surface will be washed for 30s.
Anteroposterior toothbrushing technique will be explained to the children.
Oral hygieneBehavioural
Also called Toothbrush
With the patient's own brush, supervised brushing the erupting molar with fluoridated toothpaste will be guided using the cross-toothbrushing technique
| Study group | Role | What they receive |
|---|---|---|
| 30% silver diammine fluoride | Active comparator | The 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied in erupting molars with a disposable microbrush for 3m. Then the surface will be washed for 30s. Receives: Other: 30% silver diammine fluoride |
| cross-toothbrushing | Active comparator | Children will be oriented to proceed cross-toothbrushing in erupting molars Receives: Behavioral: Oral hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries progression
Measured: 12 months
Secondary outcomes (4)
cost
Measured: 24 months
patient's satisfaction
Measured: 24 months
patient's discomfort
Measured: 24 months
duration
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startFeb 2015
- Primary completionAug 2018 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 University of Sao PauloThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Minatel Braga, University of Sao Paulo
- Investigators
- Mariana M Braga, PhD, Principal investigator, USao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508611
- Sponsor's protocol ID
- SDFtrials-02
- Status last verified
- Mar 2018
- First submitted
- 20 Dec 2011
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Braga MM, Mendes FM, De Benedetto MS, Imparato JC. Effect of silver diammine fluoride on incipient caries lesions in erupting permanent first molars: a pilot study. J Dent Child (Chic). 2009 Jan-Apr;76(1):28-33.
PubMed 19341576Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children. J Dent Res. 2002 Nov;81(11):767-70. doi: 10.1177/0810767.
PubMed 12407092Ekstrand KR, Martignon S, Ricketts DJ, Qvist V. Detection and activity assessment of primary coronal caries lesions: a methodologic study. Oper Dent. 2007 May-Jun;32(3):225-35. doi: 10.2341/06-63.
PubMed 17555173Ekstrand KR, Ricketts DN, Kidd EA, Qvist V, Schou S. Detection, diagnosing, monitoring and logical treatment of occlusal caries in relation to lesion activity and severity: an in vivo examination with histological validation. Caries Res. 1998;32(4):247-54. doi: 10.1159/000016460.
PubMed 9643366Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
PubMed 17518963Llodra JC, Rodriguez A, Ferrer B, Menardia V, Ramos T, Morato M. Efficacy of silver diamine fluoride for caries reduction in primary teeth and first permanent molars of schoolchildren: 36-month clinical trial. J Dent Res. 2005 Aug;84(8):721-4. doi: 10.1177/154405910508400807.
PubMed 16040729Yee R, Holmgren C, Mulder J, Lama D, Walker D, van Palenstein Helderman W. Efficacy of silver diamine fluoride for Arresting Caries Treatment. J Dent Res. 2009 Jul;88(7):644-7. doi: 10.1177/0022034509338671.
PubMed 19641152
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-efficacy of Silver Diammine Fluoride to Control Caries Lesions in Erupting Permanent First Molars - Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01508611
- Acronym / sponsor ID
- SDFtrials-02
- Conditions
- Dental Caries
- Keywords
- dental caries, permanent teeth, silver diamine fluoride, tooth eruption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 12 Jan 2012 (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.
This study aims to evaluate the cost-effectiveness of 30% silver diammine fluoride in the treatment of clinically caries lesions in enamel, on occlusal surfaces in first permanent molars compared to a control group that performs only the cross-toothbrushing technique and evaluate the acceptability and satisfaction of patients and responsible for the application of the solution cariostatic.
Detailed description
The sample will be comprised of 183 patients between 4 to 7 year-old, who present at least occlusal surface with initial caries lesion (ICDAS 1, 2, 3). Patients will be randomly allocated to treatments, according to the technique to be employed: (I) 30% diamine silver fluoride, (II) cross-toothbrushing technique. Will also be guided and motivated individual, where these children will be taught the technique of brushing conventional. It will be given to all patients a toothbrush. In times of reassessment, the degree of wear of the bristles of these brushes will be evaluated in order to infer the use of the same. The teeth will be evaluated by clinical and exams at baseline and after 3, 6, 12, 18 and 24 months.
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 |
|---|---|---|
| 30% silver diammine fluoride | Active comparator | Other: 30% silver diammine fluorideThe 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied in erupting molars with a disposable microbrush for 3m. Then the surface will be washed for 30s. |
| cross-toothbrushing | Active comparator | Behavioral: Oral hygieneChildren will be oriented to proceed cross-toothbrushing in erupting molars |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- erupting permanent molars (that are not in full occlusion)
- not special children
- children who present at least occlusal surface with initial caries lesion (ICDAS 1, 2, 3)
Key exclusion criteria (2 listed)
- presence of cavitated caries lesions
- presence of enamel defects (hypoplasias)
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 |
|---|---|---|
| 30% silver diammine fluorideAlso: Cariestop, BiodinamicaThe 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied with a disposable microbrush for 3m. Then the surface will be washed for 30s. Anteroposterior toothbrushing technique will be explained to the children. | Other | 30% silver diammine fluoride |
| Oral hygieneAlso: ToothbrushWith the patient's own brush, supervised brushing the erupting molar with fluoridated toothpaste will be guided using the cross-toothbrushing technique | Behavioural | cross-toothbrushing |
Primary outcome
Caries progression
Time frame: 12 months
4 secondary outcomes
cost
Time frame: 24 months
patient's satisfaction
Time frame: 24 months
patient's discomfort
Time frame: 24 months
duration
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Background: PubMed 19341576Braga MM, Mendes FM, De Benedetto MS, Imparato JC. Effect of silver diammine fluoride on incipient caries lesions in erupting permanent first molars: a pilot study. J Dent Child (Chic). 2009 Jan-Apr;76(1):28-33.
- Background: PubMed 12407092Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children. J Dent Res. 2002 Nov;81(11):767-70. doi: 10.1177/0810767.
- Background: PubMed 17555173Ekstrand KR, Martignon S, Ricketts DJ, Qvist V. Detection and activity assessment of primary coronal caries lesions: a methodologic study. Oper Dent. 2007 May-Jun;32(3):225-35. doi: 10.2341/06-63.
- Background: PubMed 9643366Ekstrand KR, Ricketts DN, Kidd EA, Qvist V, Schou S. Detection, diagnosing, monitoring and logical treatment of occlusal caries in relation to lesion activity and severity: an in vivo examination with histological validation. Caries Res. 1998;32(4):247-54. doi: 10.1159/000016460.
- Background: PubMed 17518963Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
- Background: PubMed 16040729Llodra JC, Rodriguez A, Ferrer B, Menardia V, Ramos T, Morato M. Efficacy of silver diamine fluoride for caries reduction in primary teeth and first permanent molars of schoolchildren: 36-month clinical trial. J Dent Res. 2005 Aug;84(8):721-4. doi: 10.1177/154405910508400807.
- Background: PubMed 19641152Yee R, Holmgren C, Mulder J, Lama D, Walker D, van Palenstein Helderman W. Efficacy of silver diamine fluoride for Arresting Caries Treatment. J Dent Res. 2009 Jul;88(7):644-7. doi: 10.1177/0022034509338671.
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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.
Mariana M Braga, PhD principal investigator
USao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30% silver diammine fluoride and Oral hygiene in people with Dental Caries, run by University of Sao Paulo 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 3 inclusion and 2 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 21 Mar 2018. 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.
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?
Caries progression (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 NCT01508611, which also lists 7 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 21 Mar 2018.