Dental CariesNCT01477385
Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth
A study testing Resin Infiltration, 30% Silver Diammine Fluoride and Dental Flossing in people with Dental Caries and Compliance Behavior, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study aims to evaluate the effectiveness of 30% silver diamine fluoride in the treatment of clinically caries lesions in enamel, with radiographic image restricted to the enamel or the outer third of dentin on the proximal surfaces of primary and permanent posterior teeth. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Dental Caries, Compliance Behavior
- What is being tested?
- Resin Infiltration, 30% Silver Diammine Fluoride and Dental Flossing
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Oct 2018
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary teeth: distal surface of the first molar, mesial surface of the second molar and distal surface of the second molar (when the first permanent molar is present) with initial caries lesion (ICDAS 1, 2 or 3).
- Permanent teeth: distal surface of the first premolar, mesial surface of the second premolar, distal surface of the second premolar, mesial surface of the first molar, distal surface of the first molar and mesial surface of the second molar with initial caries lesion (ICDAS 1, 2 or 3).
Who cannot join
- Mesial surface of the first primary molar/premolar by the smaller contact with the distal surface of the canines. It will be also excluded the surfaces that show proximal restorations, sealants, cavities, defects, as well as intact teeth.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade de São Paulo
São Paulo, São Paulo, 05508-000
Mariana Braga, PhD, 55 11 30917835, mmbraga@usp.br
Fausto Mendes, PhD
About this study
Official title: Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth: a Randomized Placebo-controlled Study.
This study aims to evaluate the effectiveness of 30% silver diamine fluoride in the treatment of clinically caries lesions in enamel, with radiographic image restricted to the enamel or the outer third of dentin on the proximal surfaces of primary and permanent posterior teeth. It also aims to compare it to the resin infiltration and to the control of proximal biofilm through the oral hygiene.
Read the detailed description
The sample will be comprised of 141 patients between 3 to 10 year-old and 504 proximal surfaces of 12-to-17-year-old adolescents, who present at least one proximal surface with initial caries lesion. Patients will be randomly allocated to treatments, according to the technique to be employed: (I) resin infiltration (II) 30% diamine silver fluoride, (III) just daily flossing by the patient. All subjects will receive placebo treatments performed in other groups. The teeth will be evaluated by clinical and radiographic exams at baseline and after 1, 3, 6, 12, 18 and 24 months. In 1, 3 and 18 months will just be evaluated aspects related to the biofilm.
- Conditions
- Dental Caries, Compliance Behavior
- Being tested
- Resin Infiltration, 30% Silver Diammine Fluoride, Dental Flossing, Resin Infiltration Placebo, 30% Silver Diammine Fluoride Placebo
- Keywords
- dental caries, primary teeth, permanent teeth, silver diamine fluoride
- Medical subject headings
- Dental Caries, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin InfiltrationProcedure or surgery
Also called Icon
After cleaning the proximal surface with caries lesion, it will be performed the local infiltration anesthesia and adaptation of the rubber dam. The adjacent tooth will be protected by plastic or metal strip. Hydrochloric acid 15% will be applied on the lesion, which will be washed and dried. The surface should be dried by applying 95% ethanol and air-way syringe. The resin infiltration (Icon, DMG) will be applied on the lesion. The resin will be polymerized and applied again and polymerized.
30% Silver Diammine FluorideProcedure or surgery
Also called Cariestop
It will be cleaned like group I. Soft tissues will be protected with petroleum jelly. The 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied with a disposable microbrush for 3m. Then the surface will be washed for 30s.
Dental FlossingProcedure or surgery
Also called Oral hygiene
In this group, the patient will perform only mechanical removal of biofilm to floss daily.
Resin Infiltration PlaceboProcedure or surgery
Also called Icon Placebo
In this group, the patient will be held only inserting the rubber dam and applied sterile water as a substitute for acid, ethanol and resin infiltration.
30% Silver Diammine Fluoride PlaceboProcedure or surgery
Also called Cariestop Placebo
Soft tissues will be protected with petroleum jelly. The patient will receive sterile water application with a disposable microbrush for 3m. Then the surface will be washed for 30s.
| Study group | Role | What they receive |
|---|---|---|
| Resin Infiltration | Active comparator | Resin Infiltration 30% Silver Diammine Fluoride Placebo Dental Flossing Receives: Procedure: Resin Infiltration; Procedure: Dental Flossing; Procedure: 30% Silver Diammine Fluoride Placebo |
| 30% Silver Diammine Fluoride | Experimental | 30% Silver Diammine Fluoride Resin Infiltration Placebo Dental Flossing Receives: Procedure: 30% Silver Diammine Fluoride; Procedure: Dental Flossing; Procedure: Resin Infiltration Placebo |
| Oral Hygiene | Active comparator | Dental Flossing 30% Silver Diammine Fluoride Placebo Resin Infiltration Placebo Receives: Procedure: Dental Flossing; Procedure: Resin Infiltration Placebo; Procedure: 30% Silver Diammine Fluoride Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression of initial lesion caries
Measured: 12 and 24 months
Secondary outcomes (1)
approximal plaque reduction
Measured: 1, 3, 6, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Mariana Minatel Braga, University of Sao Paulo
- Investigators
- Mariana M Braga, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477385
- Sponsor's protocol ID
- SDFtrials-01
- Status last verified
- May 2016
- First submitted
- 16 Nov 2011
- Last updated
- 4 May 2016
- 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). 2009a;76(1):28-33. Braga MM, Morais CC, Nakama RC, Leamari VM, Siqueira WL, Mendes FM. In vitro performance of methods of approximal caries detection in primary molars. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009b;108(4):e35-41. Cagetti MG, Campus G, Sale S, Cocco F, Strohmenger L, Lingström P. Association between interdental plaque acidogenicity and caries risk at surface level: a cross sectional study in primary dentition. Int J Paediatr Dent. 2011;21(2):119-25. Ekstrand KR, Bakhshandeh A, Martignon S. Treatment of proximal superficial caries lesions on primary molar teeth with resin infiltration and fluoride varnish versus fluoride varnish only: efficacy after 1 year. Caries Res. 2010;44(1):41-6.
Mattos-Silveira J, Floriano I, Ferreira FR, Vigano ME, Frizzo MA, Reyes A, Novaes TF, Moriyama CM, Raggio DP, Imparato JC, Mendes FM, Braga MM. New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial. Trials. 2014 Nov 19;15:448. doi: 10.1186/1745-6215-15-448.
PubMed 25409545
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth: a Randomized Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT01477385
- Acronym / sponsor ID
- SDFtrials-01
- Conditions
- Dental Caries, Compliance Behavior
- Keywords
- dental caries, primary teeth, permanent teeth, silver diamine fluoride
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jan 2012
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 22 Nov 2011 (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 effectiveness of 30% silver diamine fluoride in the treatment of clinically caries lesions in enamel, with radiographic image restricted to the enamel or the outer third of dentin on the proximal surfaces of primary and permanent posterior teeth. It also aims to compare it to the resin infiltration and to the control of proximal biofilm through the oral hygiene.
Detailed description
The sample will be comprised of 141 patients between 3 to 10 year-old and 504 proximal surfaces of 12-to-17-year-old adolescents, who present at least one proximal surface with initial caries lesion. Patients will be randomly allocated to treatments, according to the technique to be employed: (I) resin infiltration (II) 30% diamine silver fluoride, (III) just daily flossing by the patient. All subjects will receive placebo treatments performed in other groups. The teeth will be evaluated by clinical and radiographic exams at baseline and after 1, 3, 6, 12, 18 and 24 months. In 1, 3 and 18 months will just be evaluated aspects related to the biofilm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resin Infiltration | Active comparator | Procedure: Resin Infiltration, Procedure: Dental Flossing, Procedure: 30% Silver Diammine Fluoride PlaceboResin Infiltration 30% Silver Diammine Fluoride Placebo Dental Flossing |
| 30% Silver Diammine Fluoride | Experimental | Procedure: 30% Silver Diammine Fluoride, Procedure: Dental Flossing, Procedure: Resin Infiltration Placebo30% Silver Diammine Fluoride Resin Infiltration Placebo Dental Flossing |
| Oral Hygiene | Active comparator | Procedure: Dental Flossing, Procedure: Resin Infiltration Placebo, Procedure: 30% Silver Diammine Fluoride PlaceboDental Flossing 30% Silver Diammine Fluoride Placebo Resin Infiltration Placebo |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Primary teeth: distal surface of the first molar, mesial surface of the second molar and distal surface of the second molar (when the first permanent molar is present) with initial caries lesion (ICDAS 1, 2 or 3).
- Permanent teeth: distal surface of the first premolar, mesial surface of the second premolar, distal surface of the second premolar, mesial surface of the first molar, distal surface of the first molar and mesial surface of the second molar with initial caries lesion (ICDAS 1, 2 or 3).
Key exclusion criteria (1 listed)
- Mesial surface of the first primary molar/premolar by the smaller contact with the distal surface of the canines. It will be also excluded the surfaces that show proximal restorations, sealants, cavities, defects, as well as intact teeth.
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: IconAfter cleaning the proximal surface with caries lesion, it will be performed the local infiltration anesthesia and adaptation of the rubber dam. The adjacent tooth will be protected by plastic or metal strip. Hydrochloric acid 15% will be applied on the lesion, which will be washed and dried. The surface should be dried by applying 95% ethanol and air-way syringe. The resin infiltration (Icon, DMG) will be applied on the lesion. The resin will be polymerized and applied again and polymerized. | Procedure or surgery | Resin Infiltration |
| 30% Silver Diammine FluorideAlso: CariestopIt will be cleaned like group I. Soft tissues will be protected with petroleum jelly. The 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied with a disposable microbrush for 3m. Then the surface will be washed for 30s. | Procedure or surgery | 30% Silver Diammine Fluoride |
| Dental FlossingAlso: Oral hygieneIn this group, the patient will perform only mechanical removal of biofilm to floss daily. | Procedure or surgery | 30% Silver Diammine Fluoride, Oral Hygiene, Resin Infiltration |
| Resin Infiltration PlaceboAlso: Icon PlaceboIn this group, the patient will be held only inserting the rubber dam and applied sterile water as a substitute for acid, ethanol and resin infiltration. | Procedure or surgery | 30% Silver Diammine Fluoride, Oral Hygiene |
| 30% Silver Diammine Fluoride PlaceboAlso: Cariestop PlaceboSoft tissues will be protected with petroleum jelly. The patient will receive sterile water application with a disposable microbrush for 3m. Then the surface will be washed for 30s. | Procedure or surgery | Oral Hygiene, Resin Infiltration |
Primary outcome
progression of initial lesion caries
Time frame: 12 and 24 months
1 secondary outcome
approximal plaque reduction
Time frame: 1, 3, 6, 12, 18 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- BackgroundBraga 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). 2009a;76(1):28-33. Braga MM, Morais CC, Nakama RC, Leamari VM, Siqueira WL, Mendes FM. In vitro performance of methods of approximal caries detection in primary molars. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009b;108(4):e35-41. Cagetti MG, Campus G, Sale S, Cocco F, Strohmenger L, Lingström P. Association between interdental plaque acidogenicity and caries risk at surface level: a cross sectional study in primary dentition. Int J Paediatr Dent. 2011;21(2):119-25. Ekstrand KR, Bakhshandeh A, Martignon S. Treatment of proximal superficial caries lesions on primary molar teeth with resin infiltration and fluoride varnish versus fluoride varnish only: efficacy after 1 year. Caries Res. 2010;44(1):41-6.
- Derived from this study: PubMed 25409545Mattos-Silveira J, Floriano I, Ferreira FR, Vigano ME, Frizzo MA, Reyes A, Novaes TF, Moriyama CM, Raggio DP, Imparato JC, Mendes FM, Braga MM. New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial. Trials. 2014 Nov 19;15:448. doi: 10.1186/1745-6215-15-448.
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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
University of Sao 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 Resin Infiltration, 30% Silver Diammine Fluoride and Dental Flossing in people with Dental Caries and Compliance Behavior, 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 2 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 4 May 2016. 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?
Contact Mariana M Braga, PhD (55 11 30917835, mmbraga@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression of initial lesion caries (time frame: 12 and 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 NCT01477385, 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 4 May 2016.