Can Repair Increase the Useful Life of Composite Resins?

NCT02043873 | Completed DMC

• 1 other identifier: FOUCH2012/10
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: The aim of this prospective, randomized, triple-blind cohort study was to assess the longevity of repairs to localized clinical defects in composite restorations that were initially scheduled to be treated with a restoration replacement Methods: 28 patients aged 18 to 80 years with 50 composite restorations were recruited.Restorations with clinically diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo) were randomly assigned to the Repair (n = 25) or Replacement (n = 25) group, the quality of the restorations was scored according to the modified USPHS criteria. A Wilcoxon test was performed for comparisons between the same groups (CI=0.05). A Friedman test was utilized for multiple comparisons between different years of the same group.

Conditions

Replacement; Repair; Composites Restorations

Keywords

Clinical Trial; Composite Restorations; Restorations Repair; Replacement Restorations; Operative Dentistry.

Outcome Measures

Primary Outcomes (1)

• Quality composites restorations

  up to 10 years

Study Arms (2)

25 composite restorations replaced

25 composite replaced with clinically diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo)

25 composite repaired

25 composite repaired with clinically diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo)

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 28 patients aged 18 to 80 years (mean 26.5 years) of both females (58%) and males (42%) with 50 composite restorations were recruited at the Operative Dentistry Clinic at the Dental School of the University of Chile

You may qualify if:

• Patients with localized marginal deficiencies of composite restorations that were clinically judged to be suitable for repair, sealing, or refurbishing according to USPHS criteria (Table 1).
• 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 older than 18 years.
• Patients who agreed and signed the consent form for participating in the study.
• Area out of the restoration´s 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 special aesthetic requirements that could not be solved by repair treatments.
• 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.

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Eduardo Fernández Godoy

Santiango, Met, 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 Design

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

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 23, 2014
• Study Start: August 1, 2003
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 23, 2014

Record last verified: 2014-01

Locations

CL (1)