Tooth DemineralizationPhase 3NCT02400957
Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets
A Phase 3 study testing Silver nanoparticles in people with Tooth Demineralization, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial summary
Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets. Read more about this study
- Who is it for?
- Ages 10 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Demineralization
- What is being tested?
- Silver nanoparticles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2014to May 2015
- Phase
- Phase 3
- 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 10 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients candidates for orthodontic treatment.
Who cannot join
- Patients with O.D 11 and / or 21 absent.
- Patients who present dentures of any kind in OD 11 and 21.
- Patients presenting endodontic OD 11 and 21.
- Patients presenting data gingivitis day cementing brackets.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Gabriela Moreno Meraz
San Luis Potosí City, San Luis Potosí, 78210
About this study
Official title: Effectiveness of the Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets. ECCA
Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.
Read the detailed description
Randomized, split mouth, double-blind, placebo controlled trial. Half of the mouth was applied silver nanoparticles incorporated into the primer orthodontic Transbond XT and the other half with primer-bond as placebo. Evaluate the effectiveness with Diagnodent - pen in preventing enamel demineralization adjacent to brackets.
- Conditions
- Tooth Demineralization
- Being tested
- Silver nanoparticles, Placebo
- Keywords
- silver nanoparticles, demineralization, brackets
- Medical subject headings
- Tooth Demineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver nanoparticlesOther
Half of the mouth was applied silver nanoparticles. Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.
PlaceboOther
Also called Primer-bond
Half of the mouth was applied placebo. Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.
| Study group | Role | What they receive |
|---|---|---|
| Silver nanoparticles | Experimental | Half of the mouth was applied silver nanoparticles. Allocation was randomized. Receives: Other: Silver nanoparticles |
| Placebo | Experimental | Half of the mouth was applied placebo. Allocation was randomized. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
enamel demineralization (Diagnodent - pen evaluation)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
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 Tooth DemineralizationStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Moreno-Meraz, Universidad Autonoma de San Luis Potosí
- Investigators
- Mauricio Pierdant, Profesor, Study director, Universidad Autonoma San Luis Potosi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400957
- Sponsor's protocol ID
- CEI-FE-023-013
- Status last verified
- Mar 2015
- First submitted
- 24 Mar 2015
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hernandez-Sierra JF, Galicia-Cruz O, Angelica SA, Ruiz F, Pierdant-Perez M, Pozos-Guillen AJ. In vitro cytotoxicity of silver nanoparticles on human periodontal fibroblasts. J Clin Pediatr Dent. 2011 Fall;36(1):37-41. doi: 10.17796/jcpd.36.1.d677647166398886.
PubMed 22900442
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets. ECCA
- ClinicalTrials.gov ID
- NCT02400957
- Acronym / sponsor ID
- CEI-FE-023-013
- Conditions
- Tooth Demineralization
- Keywords
- silver nanoparticles, demineralization, brackets
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 27 Mar 2015 (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.
Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.
Detailed description
Randomized, split mouth, double-blind, placebo controlled trial. Half of the mouth was applied silver nanoparticles incorporated into the primer orthodontic Transbond XT and the other half with primer-bond as placebo. Evaluate the effectiveness with Diagnodent - pen in preventing enamel demineralization adjacent to brackets.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver nanoparticles | Experimental | Other: Silver nanoparticlesHalf of the mouth was applied silver nanoparticles. Allocation was randomized. |
| Placebo | Experimental | Other: PlaceboHalf of the mouth was applied placebo. Allocation was randomized. |
Who may qualify
- Ages
- 10 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients candidates for orthodontic treatment.
Key exclusion criteria (4 listed)
- Patients with O.D 11 and / or 21 absent.
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 |
|---|---|---|
| Silver nanoparticlesHalf of the mouth was applied silver nanoparticles. Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets. | Other | Silver nanoparticles |
| PlaceboAlso: Primer-bondHalf of the mouth was applied placebo. Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets. | Other | Placebo |
Primary outcome
enamel demineralization (Diagnodent - pen evaluation)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
- Results publication: PubMed 22900442Hernandez-Sierra JF, Galicia-Cruz O, Angelica SA, Ruiz F, Pierdant-Perez M, Pozos-Guillen AJ. In vitro cytotoxicity of silver nanoparticles on human periodontal fibroblasts. J Clin Pediatr Dent. 2011 Fall;36(1):37-41. doi: 10.17796/jcpd.36.1.d677647166398886.
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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.
Mauricio Pierdant, Profesor study director
Universidad Autonoma San Luis Potosi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Silver nanoparticles in people with Tooth Demineralization, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
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 4 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 27 Mar 2015. 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 Mexico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
enamel demineralization (Diagnodent - pen evaluation) (time frame: 8 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 NCT02400957, 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 27 Mar 2015.