Increasing Composite Restorations Sealants (SEALCOMP)

April 16, 2014 updated by: Eduardo Fernandez, University of Chile

Increasing Longevity of Composite Restorations With Defective Margins With Sealants. Controlled Clinical Trial 10 Years Follow-up

A cohort of 20 patients aged 18 to 80 years (mean 28.35 years) of both genres females (65%) and males (35%) with 80 composite restorations were recruited at the Operative Dentistry Clinic at the Dental School of the University of Chile. All participants presented with marginal adaptation clinical features that deviated from the ideal and were rated Bravo according to the modified United States Public Health Service (USPHS) criteria for the sealing group and no treatment group. As a positive control were considered composites with alpha values in marginal adaptation. The protocol was approved by the Institutional Research Ethics Committee of the Dental School at the University of Chile (Project PRI-ODO-0207). All of the patients signed informed-consent forms and completed registration form. The selection criteria are summarized below.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inclusion Criteria for Allocated groups :

Patients with localized marginal deficiencies (Bravo Ryge Criterial) of composite restorations that were clinically judged to be suitable for sealing according to USPHS criteria.

Patients with more than 20 teeth. Restorations in functional occlusions with an opposing natural tooth. Asymptomatic restored tooth. At least one proximal contact area with a neighbouring tooth. Patients are older than 18 years. Patients who agreed and signed a consent form for participating in the study. Area out of the restoration´s failure is in good condition.

Inclusion Criteria for Positive Control group :

Composite resins with alpha value in adaptation marginal criterial

Exclusion criteria:

Patients with contra-indications for regular dental treatment based on their medical history.

Patients with xerostomia or taking medication that significantly decreased salivary flow.

Patients with a high risk of caries. Patients with psychiatric or physical diseases, which interfered with oral hygiene.

Patients with localized marginal deficiencies > 1 mm. and/or secondary caries adjacent to composite restorations , or major defects 2.2 Treatment Group Criteria Initially, 356 restorations (28 patients) were evaluated and assigned in accordance with the modified USPHS criteria, from which 80 were selected in accordance with the inclusion criteria. Restorations with marginal defects (>0.5mm and <1mm) and/or marginal staining (Bravo) were randomly assigned to the Sealing (n = 20) or no treatment (n = 20) group. The randomization was performed by the Power Analysis and Sample Size System (Excel 2000,Microsoft,SEA, USA).

2.3 Restoration Assessment The quality of the restorations was scored according to the modified USPHS criteria. Two examiners underwent calibration exercises each year (JM and EF). The Cohen's Kappa inter-examiner coefficient was 0.74 at the baseline and 0.87 at ten years. Immediately after the treatment (baseline) and 10 years later, the examiners assessed the restorations independently by direct visual and tactile examination with mouth mirror number 5 and explorer number 23 (Hu Friedy Mfg. Co. Inc., Chicago, IL, USA) and indirectly by radiographic examination (bite wing). The four parameters examined were anatomic form, secondary caries, marginal staining and marginal adaptation. If the difference was recorded between the two examiners, and if they could not reach an agreement, a third clinician, who also underwent the calibration exercises (GM), made the final decision.

2.4 Treatment Groups 2.4.1 Sealing For this group, defective areas were acid etched with 35% phosphoric acid for 15 seconds. A resin-based sealant (Clinpro Sealant, 3M ESPE) was applied over the defective area. The sealant was polymerized with a photocuring unit (Curing Light 2500, 3M ESPE) for 40 seconds. Rubber dam isolation was used for this procedure.

2.4.2 No treatment The composite resin restorations had marginal defects, but were clinically acceptable, did not receive treatment.

2.4.3 Positive control Composite resins with alpha value in marginal adaptation criteria

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Facultad de Odontología Universidad de Chile

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with localized marginal deficiencies (Bravo Ryge Criterial) of composite restorations that were clinically judged to be suitable for sealing according to USPHS criteria.
  • Patients with more than 20 teeth.
  • Restorations in functional occlusions with an opposing natural tooth.
  • Asymptomatic restored tooth.
  • At least one proximal contact area with a neighbouring tooth.
  • Patients are older than 18 years.
  • Patients who agreed and signed a consent form for participating in the study.
  • Area out of the restoration´s failure is in good condition.

Inclusion Criteria for Positive Control group :

  • Composite resins with alpha value in adaptation marginal criterial

Exclusion Criteria:

  • Patients with contra-indications for regular dental treatment based on their medical history.
  • Patients with xerostomia or taking medication that significantly decreased salivary flow.
  • Patients with a high risk of caries.
  • Patients with psychiatric or physical diseases, which interfered with oral hygiene.
  • Patients with localized marginal deficiencies > 1 mm. and/or secondary caries adjacent to composite restorations , or major defects

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No treatment
The composite resin restorations had marginal defects, but were clinically acceptable, did not receive treatment
No Intervention: Positive control
Composite resins with alpha value in marginal adaptation criteria
Experimental: Intervention
For this group, defective areas were acid etched with 35% phosphoric acid for 15 seconds. A resin-based sealant (Clinpro Sealant, 3M ESPE) was applied over the defective area. The sealant was polymerized with a photocuring unit (Curing Light 2500, 3M ESPE) for 40 seconds. Rubber dam isolation was used for this procedure
Procedure: Sealant
resin-based sealant (Clinpro Sealant, 3M ESPE)
Other Names:
  • Clinpro Sealant
  • Alpha seal
  • Prime Dent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in quality of restorations
Time Frame: 1 year
The quality of the restorations was scored according to the modified USPHS criteria. Two examiners underwent calibration exercises each year (JM and EF). Immediately after the treatment (baseline) and 10 years later, the examiners assessed the restorations independently by direct visual and tactile examination with mouth mirror number 5 and explorer number 23 (Hu Friedy Mfg. Co. Inc., Chicago, IL, USA) and indirectly by radiographic examination (bite wing). The four parameters examined were anatomic form, secondary caries, marginal staining and marginal adaptation. If the difference was recorded between the two examiners, and if they could not reach an agreement, a third clinician, who also underwent the calibration exercises (GM), made the final decision.
1 year

Collaborators and Investigators

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

Sponsor

University of Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2003

Primary Completion (Actual)

May 1, 2003

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FOUCH2012/10-3

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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