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A 5-year Clinical Trial Assessing the Effects of a Surface Sealant on Composite Resin Class I Restorations

NCT02899247 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-09-14

No results posted yet for this study

Summary

This trial, based on a split mouth and double-blind design, will evaluate the effects of a surface sealant on the clinical performance of composite resin class I restorations. According to eligibility criteria, 10 pairs of upper and lower molars or premolars will be restored with Esthet X composite resin. For each pair, one surface will be sealed with Lasting Touch surface sealant. A clinical evaluation will be performed by two experienced operators using modified USPHS (United States Public Health service) after 5 years after treatment. Data will be analyzed using the McNemar test (p \< 0.05).

Conditions

  • Definitive Restorations, Longevity

Interventions

PROCEDURE

Surface sealant

Device: * Enamel and dentin etching with 37% phosphoric acid (Scotchbond Etchant; 3M/ESPE, St. Paul, MN, USA) for 30 s and 15 s. * Two coats of one-bottle adhesive (Adper TM Single Bond 2, 3M/ESPE, St. Paul, MN, USA) will be applied homogeneously to the surface with a disposable micro-brush. * Cavities will be restored with 2 mm increments of composite resin (Z350, 3M/ESPE, St. Paul, MN, USA) * 7 Days after: Finishing and polishing will be performed with fine diamond and multilaminated burs, one step polishing system Pogo (Dentsply, Caulk, USA). * The composite surface and 1 mm external limit will be etched with a 37% acid phosphoric and after will be covered using a nanotechnology liquid polish system (Lasting Touch, Dentsply Caulk, Milford, DE, USA).

PROCEDURE

No surface sealant

Device: * Enamel and dentin etching with 37% phosphoric acid (Scotchbond Etchant; 3M/ESPE, St. Paul, MN, USA) for 30 s and 15 s. * Two coats of one-bottle adhesive (Adper TM Single Bond 2, 3M/ESPE, St. Paul, MN, USA) will be applied homogeneously to the surface with a disposable micro-brush. * Cavities will be restored with 2 mm increments of composite resin (Z350, 3M/ESPE, St. Paul, MN, USA) * 7 Days after: Finishing and polishing will be performed with fine diamond and multilaminated burs, one step polishing system Pogo (Dentsply, Caulk, USA).

Sponsors & Collaborators

  • Flavia Pardo Salata Nahsan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-10-31
Completion
2016-06-30

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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 NCT02899247 on ClinicalTrials.gov