Composite Resins Reconditioned, Behavior and Survival: Clinical Follow-up 10 Years

NCT02222701 | Completed DMC

• 1 other identifier: FOUCH2012/10-4
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the clinical performance of resin composite restorations refurbished and compare with 2 groups of resins, 1 without treatment and another replaced resins acted as controls. The null hypothesis of this study is that the group of refurbished resins have a similar behavior to the control groups.

Conditions

Unsatisfactory Restoration of Tooth

Keywords

composite; dental; longevity

Outcome Measures

Primary Outcomes (1)

• Changes in quality of restorations

  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

Study Arms (3)

Replacement

Composite resins with Alpha values for the marginal adaptation criteria were used as the positive control and were made with resin composite (Filtek Supreme, 3M ESPE), eith rubber dam isolation and the adhesive system L-Pop Prompt (3M-ESPE)

No treatment

Composite resin restorations (Z100, 3M ESPE) in general clinically acceptable, did not receive treatment.

Refurbishing

For this group, The dentists finished the occlusal, lingual or facial surfaces of defective RBC restorations with the medium series of aluminum oxide disks (Sof-Lex,3M ESPE) or carbide burs (12 and 30 blades,Brasseler USA, Dental Instrumentation,Savannah, Ga.) and then polished them with afine series of aluminum oxide disks (Sof-Lex, 3M ESPE) and diamond-impregnated composite polisher (ComposiPro Diacomp, Brasseler). For restorations in which proximal surface areas were affected, the clinicians smoothed them with interproximal aluminum oxide finishing strips (Sof-Lex Finishing Strips, 3M ESPE).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any person with composite restorations

You may qualify if:

• Patients with more than 20 teeth.
• Restorations in functional occlusion, with an opposing natural tooth.
• Asymptomatic restored tooth.
• At least one proximal contact area with a neighboring tooth.
• Patients older than 18 years.
• Patients who agreed and signed a consent form for participating in the study.
• Area outside of the restoration failure is in good condition.

You may not qualify if:

• Patients with contra-indications for regular dental treatment based on their medical history.
• Patients with xerostomia or individuals 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.

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Eduardo Fernandez Godoy

Santiago, 7500505, Chile

Location

Related Publications (2)

• Moncada G, Vildosola P, Fernandez E, Estay J, de Oliveira Junior OB, de Andrade MF, Martin J, Mjor IA, Gordan VV. Longitudinal results of a 10-year clinical trial of repair of amalgam restorations. Oper Dent. 2015 Jan-Feb;40(1):34-43. doi: 10.2341/14-045-C. Epub 2014 Aug 6.

  PMID: 25100406 RESULT

• Fernandez E, Martin J, Vildosola P, Oliveira Junior OB, Gordan V, Mjor I, Bersezio C, Estay J, de Andrade MF, Moncada G. Can repair increase the longevity of composite resins? Results of a 10-year clinical trial. J Dent. 2015 Feb;43(2):279-86. doi: 10.1016/j.jdent.2014.05.015. Epub 2014 Jun 4.

  PMID: 24907560 RESULT

Study Officials

• eduardo fernandez

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eduardo Fernandez Godoy

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 21, 2014
• Study Start: May 1, 2003
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 21, 2014

Record last verified: 2014-08

Locations

CL (1)