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NCT02649816 Clinical Trial

Effectiveness of Resin Sealants: Retrospective Cohort Study

Dental Caries Clinical Trial

Official title:
A Retrospective Cohort Study on Clinical Success of Resin Sealants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02649816
Other study ID # 2
Secondary ID
Status Completed
Phase N/A
First received December 23, 2015
Last updated January 6, 2016
Start date March 2011
Est. completion date December 2013

Study information
Verified date January 2016
Source University of Campinas, Brazil
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Observational

Clinical Trial Summary

This retrospective cohort study assessed sealant clinical success applied to pit and fissure by dental undergraduate students at Piracicaba Dental School - Brazil.

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.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date December 2013
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 14 Years
Eligibility Inclusion Criteria:

- A population presenting first and second permanent molars with sealed occlusal surfaces by dental undergraduate students at Piracicaba Dental School Brazil.

Exclusion Criteria:

- First and second permanent molars with sealed occlusal surfaces by dentistry.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fernanda Miori Pascon

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 1 year Yes
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