Dental CariesNCT02649816
Effectiveness of Resin Sealants: Retrospective Cohort Study
An observational study of Dental Caries, run by Fernanda Miori Pascon.
Trial summary
This retrospective cohort study assessed sealant clinical success applied to pit and fissure by dental undergraduate students at Piracicaba Dental School - Brazil. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Dec 2013
- Phase
- Observational
- 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 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients treated at Piracicaba Dental School - Brazil
Who may be able to join
- A population presenting first and second permanent molars with sealed occlusal surfaces by dental undergraduate students at Piracicaba Dental School Brazil.
Who cannot join
- First and second permanent molars with sealed occlusal surfaces by dentistry.
About this study
Official title: A Retrospective Cohort Study on Clinical Success of Resin Sealants
This retrospective cohort study assessed sealant clinical success applied to pit and fissure by dental undergraduate students at Piracicaba Dental School - Brazil.
Read the detailed description
A population presenting 1st/2nd permanent molars with sealed occlusal surfaces were considered. Dental records were reviewed for: patient's caries risk (High/Low); operator experience (scores 1 to 4, beginners to seniors); number of follow-up visits; isolation procedure; sealant/tooth type; and age at placement. Posteriorly, the patients were called to dental evaluation and the sealed teeth were classified regarding the sealant presence, partial presence or absence, with or without caries, or sealant replacement to a restorative material in Satisfactory or Unsatisfactory, considering the caries presence/absence. Successful outcome was considered in the caries absence.
- Conditions
- Dental Caries
- Keywords
- Pit and fissure sealants, Dental Caries, Prevention, Dental undergraduate students, patient's caries risk
- Medical subject headings
- Dental Caries, Van der Woude syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability (%) of the caries development in the treated teeth assessed by Kaplan-Meier survival analysis (Bioestat 5.3).
Outcome mensuration by clinical examination (caries prevention and retention sealant) and bitewing radiograph.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fernanda Miori Pascon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fernanda Miori Pascon, University of Campinas, Brazil
- Investigators
- Juliana Camargo, Principal investigator, Piracicaba Dental School - University of CampinasKelly Moreira, Principal investigator, Piracicaba Dental School - University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649816
- Sponsor's protocol ID
- 2
- Status last verified
- Jan 2016
- First submitted
- 23 Dec 2015
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study on Clinical Success of Resin Sealants
- ClinicalTrials.gov ID
- NCT02649816
- Acronym / sponsor ID
- 2
- Conditions
- Dental Caries
- Keywords
- Pit and fissure sealants, Dental Caries, Prevention, Dental undergraduate students, patient's caries risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Fernanda Miori PasconUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Jan 2016 (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 retrospective cohort study assessed sealant clinical success applied to pit and fissure by dental undergraduate students at Piracicaba Dental School - Brazil.
Detailed description
A population presenting 1st/2nd permanent molars with sealed occlusal surfaces were considered. Dental records were reviewed for: patient's caries risk (High/Low); operator experience (scores 1 to 4, beginners to seniors); number of follow-up visits; isolation procedure; sealant/tooth type; and age at placement. Posteriorly, the patients were called to dental evaluation and the sealed teeth were classified regarding the sealant presence, partial presence or absence, with or without caries, or sealant replacement to a restorative material in Satisfactory or Unsatisfactory, considering the caries presence/absence. Successful outcome was considered in the caries absence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients treated at Piracicaba Dental School - Brazil
Key inclusion criteria (1 listed)
- A population presenting first and second permanent molars with sealed occlusal surfaces by dental undergraduate students at Piracicaba Dental School Brazil.
Key exclusion criteria (1 listed)
- First and second permanent molars with sealed occlusal surfaces by dentistry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Probability (%) of the caries development in the treated teeth assessed by Kaplan-Meier survival analysis (Bioestat 5.3).
Time frame: 1 year
Outcome mensuration by clinical examination (caries prevention and retention sealant) and bitewing radiograph.
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 7 Jan 2016.
- Individual participant dataSharing planned: No
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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.
Juliana Camargo principal investigator
Piracicaba Dental School - University of Campinas
Kelly Moreira principal investigator
Piracicaba Dental School - University of Campinas
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by Fernanda Miori Pascon.
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: finished, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Probability (%) of the caries development in the treated teeth assessed by Kaplan-Meier survival analysis (Bioestat 5.3). (time frame: 1 year). 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 7 Jan 2016.