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Clinical Follow Up of a Fissure Sealant Placed With Different Adhesive Protocols: 2-Year Randomized Split Mouth Study

NCT02998814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-12-20

No results posted yet for this study

Summary

The purpose of this study was to evaluate the retention rates of a fissure sealant placed using different adhesive protocols over 24 months.Twenty-four subjects with no restoration and caries received fissure sealants (Clinpro™Sealant, 3M/ESPE) placed with different adhesive protocols. A total of 292 sealants (73 for each group) were placed. The sealants were placed as follows; a-without adhesive (acid-etch only), b-with an etch-and-rinse adhesive (SingleBondTM), c-with a self-etch adhesive (AdperTMEasyBond), d-with acid-etch+self-etch adhesive (AdperTMEasyBond) by two previously calibrated dentists using a table of random numbers. Two other calibrated examiners, independently evaluated the sealants at baseline and at 6-, 12-, 18-, and 24-month recalls. Each sealant was evaluated in terms of caries formation being present or absent and retention using the following criteria: 1=completely retained, 2=partial loss, and 3=total loss. The Pearson χ2 test was used to evaluate differences in retention rates among the sealants for each evaluation period.

Conditions

  • Fissure Sealant Loss
  • Caries

Interventions

OTHER

acid-etch

acid-etch

OTHER

self-etch adhesive

Self etch (7th generation ) bonding agent

OTHER

etch-and-rinse adhesive

Total etch bonding agent (5th generation)

OTHER

self-etch adhesive after acid-etch

acid etch + self-etch adhesive Self etch (7th generation ) bonding agent

Sponsors & Collaborators

  • Hacettepe University

    lead OTHER

Principal Investigators

  • A.Ruya Yazici, DDS, PhD · Hacettepe University School of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
23 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-12-31
Completion
2013-01-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02998814 on ClinicalTrials.gov