Tooth; Lesion, White Spot LesionsNCT01659463
Resin Infiltratration on the Sealing of Proximal Early Caries
A study testing ICON and instruction oral hygiene in people with Tooth; Lesion, White Spot Lesions, run by Universidade Federal de Santa Maria at 1 site in Brazil.
Trial summary
Material for caries prevention dont have better results compared with non-operatory interventions. Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth; Lesion, White Spot Lesions
- What is being tested?
- ICON and instruction 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
- 39 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2011to Sep 2013
- 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 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Two early caries lesion in the same patient, lesion with the same radiolucencies images
Who cannot join
- Pregnancy, use of orthodontics appliences, use of drugs modified salivar flow, ausence of adjacent teeth
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Santa Maria
Santa Maria, Rio Grande do Sul, 97105-900
RAFAELA CORREIA, STUDENT, +555599721234, rafaela.tc@gmail.com
Julio Zenkner, MsC
About this study
Official title: Resin Infiltration on Teh Sealing of Proximal Early Caries Lesins: a Randomized Trial
Material for caries prevention dont have better results compared with non-operatory interventions.
Read the detailed description
Two gruops will be compared. One using ICON and another gruop with non-operatory interventions consisted in hygiene instrutions and fluoride topical application. The caries progression will be evalueted with radiographic observation.
- Conditions
- Tooth; Lesion, White Spot Lesions
- Being tested
- ICON, instruction oral hygiene
- Keywords
- CARIES INFILTRATION, CARIES LESION, INFILTRANT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICONOther
Also called ICON (DMG) Hamburg Germany
LOW VISCOSITY RESIN WILL BE APPLIED IN EARLY PROXIMAL CARIES LESIONS
instruction oral hygieneBehavioural
Instructions diet and hygiene oral and topical fluoride
| Study group | Role | What they receive |
|---|---|---|
| ICON - low viscosity resin | Experimental | APPLICATION OF A LOW VISCOSITY RESIN IN EARLY PROXIMAL CARIES LESIONS Receives: Other: ICON |
| INSTRUCTIONS ORAL HYGIENE | Active comparator | INSTRUCTION ORAL HYGIENE AND DIET AND TOOPICAL FLUORIDE APPLICATIONS Receives: Behavioral: instruction oral hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
caries progression in the proximal surfaces
progression in the proximal surfaces will be compared with two procedures.
Measured: One year after interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startApr 2011
- Primary completionSep 2012 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth; Lesion, 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julio Eduardo do Amaral, Universidade Federal de Santa Maria
- Investigators
- Julio E Zenkner, MsC, Principal investigator, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659463
- Sponsor's protocol ID
- 0347.0243.000-10
- Status last verified
- Aug 2012
- First submitted
- 3 Aug 2012
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resin Infiltration on Teh Sealing of Proximal Early Caries Lesins: a Randomized Trial
- ClinicalTrials.gov ID
- NCT01659463
- Acronym / sponsor ID
- 0347.0243.000-10
- Conditions
- Tooth; Lesion, White Spot Lesions
- Keywords
- CARIES INFILTRATION, CARIES LESION, INFILTRANT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 7 Aug 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.
Material for caries prevention dont have better results compared with non-operatory interventions.
Detailed description
Two gruops will be compared. One using ICON and another gruop with non-operatory interventions consisted in hygiene instrutions and fluoride topical application. The caries progression will be evalueted with radiographic observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICON - low viscosity resin | Experimental | Other: ICONAPPLICATION OF A LOW VISCOSITY RESIN IN EARLY PROXIMAL CARIES LESIONS |
| INSTRUCTIONS ORAL HYGIENE | Active comparator | Behavioral: instruction oral hygieneINSTRUCTION ORAL HYGIENE AND DIET AND TOOPICAL FLUORIDE APPLICATIONS |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Two early caries lesion in the same patient, lesion with the same radiolucencies images
Key exclusion criteria (1 listed)
- Pregnancy, use of orthodontics appliences, use of drugs modified salivar flow, ausence of adjacent 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 |
|---|---|---|
| ICONAlso: ICON (DMG) Hamburg GermanyLOW VISCOSITY RESIN WILL BE APPLIED IN EARLY PROXIMAL CARIES LESIONS | Other | ICON - low viscosity resin |
| instruction oral hygieneInstructions diet and hygiene oral and topical fluoride | Behavioural | INSTRUCTIONS ORAL HYGIENE |
Primary outcome
caries progression in the proximal surfaces
Time frame: One year after interventions
progression in the proximal surfaces will be compared with two procedures.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
Related trials for Tooth; Lesion, White Spot Lesions
Active, not recruiting
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
Bracket Bonding, Orthodontic Treatment
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Recruiting
EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH.
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Not yet recruiting
S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment
White Spot Lesion of Tooth, Orthodontic Treatment
Recruiting
Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
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.
Julio E Zenkner, MsC principal investigator
Universidade Federal de Santa Maria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICON and instruction oral hygiene in people with Tooth; Lesion, White Spot Lesions, run by Universidade Federal de Santa Maria 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 1 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 23 Aug 2012. 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 Rafaela Correia, student (+555599721234, rafaela.tc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caries progression in the proximal surfaces (time frame: One year after interventions). 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 23 Aug 2012.