Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 777 for:    region | Chile

10-years Clinical Trial of Sealed of Margin Failures (Sealant)

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.
 
ClinicalTrials.gov Identifier: NCT02075801
Recruitment Status : Completed
First Posted : March 3, 2014
Last Update Posted : March 3, 2014
Sponsor:
Information provided by (Responsible Party):
Gustavo Moncada, University of Chile

Brief Summary:
  • Assess the effectiveness of sealing localized marginal defects of amalgam restorations that were initially scheduled for replacement of restorations.
  • The hypothesis was that sealed defective margins of the amalgam restorations shows similar performance than replacement amalgam restorations.

Condition or disease Intervention/treatment
Dental Caries Secondary to Acquired Defects of Tooth Structure Other: Sealing of amalgam margin defects

  Show Detailed Description

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 32 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Longitudinal Results of a 10-years Clinical Trial of Sealed Margin Failures of Amalgam Restorations
Study Start Date : August 2003
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Group/Cohort Intervention/treatment
Defective amalgam restorations

Treatment Groups:

A. Sealing of amalgam margin defects: Defective areas were acid etched with 35% phosphoric acid for 15 seconds. A resin-based sealant (Sealant, 3MESPE)was applied over the defective area. The sealant was polymerized with a photo curing unit (Curing-Light 2500, 3MESPE) for 40 seconds. Rubber dam isolation was used for this procedure. All treatments were applied by the same clinician.

B. Replacement Group: The clinician totally removed and replaces the defective restoration with a new amalgam (Tytin, Kerr, Orange, USA). Rubber dam isolation was used for this procedure. All treatments were applied by the same clinician.

C. Control Group: The defective restorations did not receive any treatment.

Other: Sealing of amalgam margin defects
Comparison between sealing of amalgam margins defects, replacement and non treated groups.

Other: Sealing of amalgam margin defects

A.Sealing of amalgam margin defects: were acid etched with 35% phosphoric acid for 15 seconds. A resin-based sealant (Clinpro Sealant, 3MESPE) 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. All treatments were applied by the same clinician.

B.Replacement Group: The clinician totally removed and replaces the defective restoration with a new amalgam (Tytin, Kerr Corporation, Orange, CA, USA). Rubber dam isolation was used for this procedure. All treatments were applied by the same clinician.

C.Control Group: The defective restorations did not receive any treatment.

Other Name: Use of Selant to seal amalgam margins defects




Primary Outcome Measures :
  1. Changes of Amalgam restorations quality according to United Stated Public Health Service (USPHS) [ Time Frame: Baseline and 10 after treatment ]
    Restorations Assessment: The quality of the restorations were evaluated using the modified U.S. Public Health System criteria. Two examiners assessed the restorations independently and by visual and tactile examination. All the restorations were examined at baseline and ten years after treatment. The restorations assessment was carried out by five parameters: marginal adaptation, roughness, secondary caries, marginal stain and teeth sensitivity. All three clinicians participated in calibration exercises at the beginning and before the last examination took place and the inter-examiner reliability results were Kappa=0.74 at the baseline and Kappa=0.87 at the ten year.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients of the Operative Dentistry Clinics, School of Dentistry, University of Chile
Criteria

Inclusion criteria:

  • Patients with amalgam restorations with marginal deficiencies that were judged to be suitable for sealing.
  • Older than 18 years of age ¨
  • More than 20 teeth in their mouth
  • The restorations had to be in functional occlusion with an opposing natural tooth
  • With at least one proximal contact area with and adjacent tooth
  • Area out of the restoration´s failures in good condition
  • Patients who agree and sign the informed consent for participating in the study.

Exclusion Criteria:

  • Patients with contraindications for regular dental treatment based on their medical history
  • Special aesthetic requirements that could not be solved by this alternative treatment
  • Xerostomia or who were taking medication that significantly decreased salivary flow
  • High caries risk
  • Psychiatric or physical diseases, that interfered with teeth hygiene.

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 ClinicalTrials.gov identifier (NCT number): NCT02075801


Locations
Layout table for location information
Chile
University of Chile
Santiago, Region Metropolitana, Chile
Sponsors and Collaborators
University of Chile
Investigators
Layout table for investigator information
Principal Investigator: Gustavo Moncada, DDS University of Chile

Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Gustavo Moncada, Main Investigator, University of Chile
ClinicalTrials.gov Identifier: NCT02075801     History of Changes
Other Study ID Numbers: PRI-ODO-0207
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: March 3, 2014
Last Verified: February 2014
Keywords provided by Gustavo Moncada, University of Chile:
Sealant, Margins Defect, Amalgam
Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases