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

NCT02899247 | Completed Phase 4

• 1 other identifier: Un. Fed. Sergipe
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

composite resin; surface sealant

Outcome Measures

Primary Outcomes (1)

• Resin composite Longevity

  A clinical evaluation will be performed by two experienced operators using modified USPHS (United States Public Health service) at baseline, before the treatment. The parameters included will be marginal discoloration, anatomic form, secondary caries and marginal integrity.

  baseline

Secondary Outcomes (1)

• Resin composite longevity

  5-year

Study Arms (2)

No Surface Sealant

EXPERIMENTAL

Resin composite only

Procedure: No surface sealant

With surface Sealant

ACTIVE COMPARATOR

Resin composite with surface sealant application

Procedure: Surface sealant

Interventions

Surface sealant PROCEDURE

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).

With surface Sealant

No surface sealant PROCEDURE

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).

No Surface Sealant

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good oral hygiene;
• Having a class I caries lesion or unsatisfactory restoration in at least two posterior teeth (molar or premolar);
• Be in agreement and sign the consent form.

You may not qualify if:

• Patients with a proximal caries lesion;
• Presence of periodontal disease;
• Presence of symptomatic restored or non restored teeth indicating irreversible pulpal pathology;
• Presence of an abnormal occlusion or the absence of antagonist teeth;
• Presence of exposure of pulpal tissue;
• Presence of extended or large cavities.

Sponsors & Collaborators

• Flavia Pardo Salata Nahsan: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2016
• First Posted: September 14, 2016
• Study Start: April 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: June 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2016-09