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Increasing Composite Restorations Sealants (SEALCOMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02119195
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Information provided by (Responsible Party):
Eduardo Fernandez, University of Chile

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental Restoration Failure Procedure: Sealant Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Increasing Longevity of Composite Restorations With Defective Margins With Sealants. Controlled Clinical Trial 10 Years Follow-up
Study Start Date : May 2003
Actual Primary Completion Date : May 2003
Actual Study Completion Date : December 2013

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02119195

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Facultad de Odontología Universidad de Chile
Santiago, Chile
Sponsors and Collaborators
University of Chile
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Principal Investigator: Eduardo Fernández, Prof. University of Chile

Publications of Results:
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Responsible Party: Eduardo Fernandez, Prof., University of Chile Identifier: NCT02119195     History of Changes
Other Study ID Numbers: FOUCH2012/10-3
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: April 2014
Keywords provided by Eduardo Fernandez, University of Chile: