Longitudinal Results of a 10-Year Clinical Trial of Repair of Amalgam Restorations

NCT02051179 | Completed DMC

• 1 other identifier: FOUCH 2012/10/2
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective, randomized clinical trial was to assess the effectiveness of repair of localized clinical defects of amalgam restorations that were initially scheduled for replacement of restorations. A cohort of 20 patients with 40 (Class I and Class II) amalgam restorations, that presented one or more clinical features that deviated from the ideal (Bravo or Charlie) according to USPHS criteria, were randomly assigned to either, the repair or replacement group: A: repair n= 19 and B: replacement n=21. Two examiners who had calibration exercised evaluated the restorations at baseline and ten years after according to seven parameters: marginal occlusal adaptation, anatomic form, surface roughness, marginal staining, contact, secondary caries, and luster

Conditions

Unsatisfactory or Defective Restoration of Tooth

Keywords

Repair; Replacement; Dental Amalgam

Outcome Measures

Primary Outcomes (1)

• Quality amalgam restorations

  20 healthy voluteers with amalgam restorations , assesment of quality of amalgams by USPHS criterial

  10 years

Study Arms (2)

Replacement amalgam

Replacement The clinicians totally removed and replaced the defective restorations. After completing the cavity preparations, the tooth was restored with a new AM (Original D). Bonding agents and/or liners underneath the amalgam restorations were not used in this trial. Rubber dam isolation was used for all restorative treatments. .

Repair Amalgam

The clinicians (PV and CM) used Carbide burs (330-010 Komet, Brasseler GmbH Co. Postfach 160.32631, Lemgo, Germany) to explore the defective margin, carious lesion or anatomic form of the restorations. Part of the restorative material adjacent to the defect was removed as an exploratory proceedure thus allowing a proper evaluation and subsequent diagnosis of the extent of the defect. Provided that the defect was limited and localized, the clinician then removed any defective tooth tissue. Mechanical retention was employed inside the existing AM restoration. Rubber dam isolation was used for this procedure. Repair of the restorations was carried out with a dispersed-phased amalgam (Original D, Wyckle Research Inc, Carson City, NV, USA).

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

A cohort of 20 patients between the ages of 18 to 80 years old (mean 26.5 years), female (58%) and male (42%), with 40 (Class I and Class II) amalgam restorations, that presented one or more clinical features that deviated from the ideal (Bravo or Charlie according to modified United States Public Health Service USPHS criteria). All of them were recruited at the Operative Dentistry Clinic at the Dental School, University of Chile

You may qualify if:

• patients having at least one tooth with a localized marginal defective amalgam restoration(s) that was clinically determined to be suitable for repair, according to USPHS criteria
• patients with at least 20 teeth;
• restorations in functional occlusion with at least one opposing natural tooth;
• asymptomatic of post-operative sensitivity;
• with occlusal and proximal contact areas;
• patients older than 18 years; and
• patients who agreed and signed the informed consent form for participating in the study.

You may not qualify if:

• patients with contraindications for regular dental treatment based on their medical history
• patients who had special aesthetic needs that could not be solved by repair treatments
• patients with xerostomia and/or patients who were taking medication that significantly decreased salivary flow
• patients with high risk for caries
• patients with psychiatric or physical diseases, which interfered with oral hygiene

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Eduardo Fernández Godoy

Santiago, 7500505, Chile

Location

Related Publications (6)

• Martin J, Fernandez E, Estay J, Gordan VV, Mjor IA, Moncada G. Management of Class I and Class II Amalgam Restorations with Localized Defects: Five-Year Results. Int J Dent. 2013;2013:450260. doi: 10.1155/2013/450260. Epub 2013 Jan 28.

  PMID: 23431302 RESULT

• Martin J, Fernandez E, Estay J, Gordan VV, Mjor IA, Moncada G. Minimal invasive treatment for defective restorations: five-year results using sealants. Oper Dent. 2013 Mar-Apr;38(2):125-33. doi: 10.2341/12-062C. Epub 2012 Jul 11.

  PMID: 22788726 RESULT

• Fernandez EM, Martin JA, Angel PA, Mjor IA, Gordan VV, Moncada GA. Survival rate of sealed, refurbished and repaired defective restorations: 4-year follow-up. Braz Dent J. 2011;22(2):134-9. doi: 10.1590/s0103-64402011000200008.

  PMID: 21537587 RESULT

• Moncada G, Martin J, Fernandez E, Hempel MC, Mjor IA, Gordan VV. Sealing, refurbishment and repair of Class I and Class II defective restorations: a three-year clinical trial. J Am Dent Assoc. 2009 Apr;140(4):425-32. doi: 10.14219/jada.archive.2009.0191.

  PMID: 19339531 RESULT

• Moncada G, Fernandez E, Martin J, Arancibia C, Mjor IA, Gordan VV. Increasing the longevity of restorations by minimal intervention: a two-year clinical trial. Oper Dent. 2008 May-Jun;33(3):258-64. doi: 10.2341/07-113.

  PMID: 18505215 RESULT

• Moncada GC, Martin J, Fernandez E, Vildosola PG, Caamano C, Caro MJ, Mjor IA, Gordan VV. Alternative treatments for resin-based composite and amalgam restorations with marginal defects: a 12-month clinical trial. Gen Dent. 2006 Sep-Oct;54(5):314-8.

  PMID: 17004564 RESULT

Study Officials

• eduardo fernandez

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Eduardo Fernández Godoy

Study Record Dates

• First Submitted: January 25, 2014
• First Posted: January 31, 2014
• Study Start: August 1, 2003
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 31, 2014

Record last verified: 2014-01

Locations

CL (1)