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

September 13, 2016 updated by: Flavia Pardo Salata Nahsan
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The protocol was approved by the Human Ethics Committee (protocol number 133/2010, CAAE 0124.0.224.000.-10), and all patients will sign informed consent forms and complete a registration form prior to treatment.

The eligibility criteria for participation in the study include good oral hygiene, a class I caries lesion or unsatisfactory restoration in at least two posterior teeth (molar or premolar), a buccolingual extension, and a signed consent form. The exclusion criteria includes patients with a proximal caries lesion, the presence of periodontal disease, symptomatic restored or nonrestored teeth indicating irreversible pulpal pathology, an abnormal occlusion or the absence of antagonist teeth, exposure of pulpal tissue, and extended or large cavities.

This study will include 10 patients (aged 18 to 45 years) totaling 14 pairs of class I restorations (molars and premolars). These pairs will be randomly divided into two study groups, resulting in a split-mouth design.

A hybrid resin composite, Esthet X (Dentsply, Caulk, USA) and an etch-and-rinse two-step adhesive, AdperTM Single Bond (3M, ESPE) will be used for the composite restorations. For teeth with the surface sealant, they will be covered with Lasting Touch (Dentsply, Caulk, USA).

All cavity preparations and restorations will be performed by the same experienced operator, using rubber dam isolation. Cavity designs will be prepared using a #245 carbide bur (KG Sorensen, Cotia, SP, Brazil), which will be changed every five preparations. All enamel bordered cavity margins will be verified.

The restorative procedures will be performed using rubber dam isolation. In very deep cavities, the dentin will be covered with calcium hydroxide (Dycal; Dentsply Ind. e Com. Ltda., Petrópolis, RJ, Brazil) and resin-modified glass-ionomer cement (Vitrebond, 3M ESPE, St. Paul, MN, USA). In deep cavities dentin will be covered solely with resin-modified glass-ionomer cement.

The enamel and dentin will be etched with 37% phosphoric acid (Scotchbond Etchant; 3M/ESPE, St. Paul, MN, USA) for 30 s and 15 s, respectively. Then will be rinsed with water spray for 30 s and gently and thoroughly dried with absorbent paper for 10 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. The cavity will be gently brushed with a faint air jet, allowing solvent evaporation, and light-cured for 10 s with an LED light (Smart Lite OS, Dentsply Indústria e Comércio Ltda., Rio de Janeiro/RJ - Brasil), with 1270 mW/cm2 of power density.

The class I teeth cavities will be restored with 2 mm increments of composite resin, by using a steel instrument (XTS Goldstein Flexi-Thin Mini #3, Hu-Friedy, Rio de Janeiro, RJ), and light-cured for 20 s, with the same light source and power density.

The finishing and polishing procedures will be performed after seven days, using fine diamond and multilaminated burs, followed by a one step polishing system Pogo (Dentsply, Caulk, USA). These procedures will be performed using a slow-speed hand piece with water spray. The disks, burs, and points will be discarded after each use.

For teeth assigned to the control group (NSS), they will be treated with finishing and polishing procedures only. Teeth included in SS group will be covered using a nanotechnology liquid polish system (Lasting Touch, Dentsply Caulk, Milford, DE, USA) applied as per the manufacturer's directions after finishing and polishing.. For this application, the composite surface and 1 mm external limit will be etched with a 37% acid phosphoric acid gel for 30 s and thoroughly rinse. The excess water will be removed with a mild oil free air stream, as per the manufacturer's instructions. Utilizing a disposable micro brush, a uniform layer of low-viscosity agent will be applied over the etched area, gently air brushed for 15 s and light-cured with the same light source.

The quality of the restorations will be rated according to the U.S. Public Health System/Ryge criteria. Two independent experienced examiners assessed the restorations. Restorations will bee calibrated according to Cohen's Kappa. Where disagreement occurred during evaluation, a consensus will be obtained among the examiners. It will be a double-blind evaluation, as neither examiner nor patients knew the treatment under evaluation. Examinations will be performed directly using mirror and probe. The evaluations will obtained at baseline (1 to 2 weeks after insertion) and 5 year after treatment. The parameters included will be marginal discoloration, anatomic form, secondary caries and marginal integrity. Data will be statistically analyzed using the McNemar's test (p < 0.05).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: No Surface Sealant
Resin composite only
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).
Active Comparator: With surface Sealant
Resin composite with surface sealant application
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Resin composite Longevity
Time Frame: baseline
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resin composite longevity
Time Frame: 5-year
A clinical evaluation will be performed by two experienced operators using modified USPHS (United States Public Health service) at 5 years after treatment. The parameters included will be marginal discoloration, anatomic form, secondary caries and marginal integrity.
5-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Flavia Pardo Salata Nahsan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Un. Fed. Sergipe

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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