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ReplacementREPCOMPNCT02043873

Can Repair Increase the Useful Life of Composite Resins?

An observational study of Replacement and Repair, run by University of Chile at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Replacement, Repair, Composites Restorations
How many people
28 participants
Where
1 siteChile
Study dates
Aug 2003to Jan 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Chile1 site
  • Eduardo Fernández Godoy

    Santiango, Met, 7500505

Other trials in Chile

About this study

Official title: Can Repair Increase the Useful Life of Composite Resins? Clinical Trial: Triple-blind Controlled - 10 Year Follow-up

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.

Read the detailed description

A cohort of 28 patients aged 18 to 80 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. All participants presented with one or more clinical features that deviated from the ideal and were rated Bravo or Charlie according to the modified United States Public Health Service (USPHS) criteria 6. 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 a registration form. The selection criteria are summarized below.

2.2 Treatment Group Criteria Initially, 356 restorations (28 patients) were evaluated and assigned in accordance with the modified USPHS criteria, from which 50 were selected in accordance with the inclusion criteria. 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 (Figure 1). The randomization was performed by the Power Analysis and Sample Size System (PASS software v. 2008, Keysville, UT, USA), and diagnosis of active secondary caries was made based on Ekstrand criteria.

2.3 Restoration Assessment The quality of the restorations was scored according to the modified USPHS criteria. Two examiners underwent calibration exercises each year (JM and EF). The Cohen's Kappa inter-examiner coefficient was 0.74 at the baseline and 0.87 at ten years. 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 five parameters examined were marginal adaptation, anatomic form, surface roughness, secondary caries, and lustre. If a 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.

2.4 Treatment Groups 2.4.1 Repair The clinicians (PV - GM) used carbide burs (330-010 Komet, Brasseler GmbH Co., Lemgo, Germany) to explore the defective margins of the restorations, beginning with the removal of part of the restorative material adjacent to the defect to act as an exploratory cavity; this allowed a proper diagnosis and evaluation of the extent of the defect. Provided that the defect was limited and localized, the clinician then removed any defective tooth tissue. Once this material was removed, an exploratory cavity preparation was done that included removal of any demineralized and soft tooth tissue. A self-priming resin bonding system was used (Adper Prompt L-Pop; 3M ESPE, St. Paul, MN, USA), followed by restoration with a resin-based composite (RBC) restorative material (Filtek Supreme; 3M ESPE). A rubber dam isolation was used for this procedure.

2.4.2 Replacement The clinicians totally removed and replaced the defective restorations. After completing the cavity preparations, it was restored with a new resin composite (RC; Filtek Supreme; 3M ESPE). The elimination of the soft tooth tissue caries infection was done using carbide burs at high speed under full water irrigation. During the cavity preparation, no preventive extension or undercutting areas were created, and all of the cavity angles were rounded. In the deep dentin, a glass-ionomer liner was used (Vitrebond; 3M ESPE; USA). Adper Prompt L-Pop, (3M ESPE) was used per the manufacturer instructions, and RBC (Filtek Supreme; 3M ESPE) was applied by the incremental technique. The occlusion was checked, and the restorations were finished and polished following the manufacturer instructions.

Keywords
Clinical Trial, Composite Restorations, Restorations Repair, Replacement Restorations, Operative Dentistry.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02043873
Study groupRoleWhat they receive
25 composite restorations replaced25 composite replaced with clinically diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo)
25 composite repaired25 composite repaired with clinically diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality composites restorations

    Measured: up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2014 (estimated)
  2. Study startAug 2003
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02043873
Sponsor's protocol ID
FOUCH2012/10
Acronym
REPCOMP
Status last verified
Jan 2014
First submitted
21 Jan 2014
Last updated
23 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23431302
  • 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.

    PubMed 22788726
  • 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.

    PubMed 21537587
  • 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.

    PubMed 19339531
  • 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.

    PubMed 18505215
  • 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.

    PubMed 17004564

Questions about this trial

What is this clinical trial studying?

An observational study of Replacement and Repair, run by University of Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality composites restorations (time frame: up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02043873, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2014.

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