Increasing Composite Restorations Sealants

NCT02119195 | Completed DMC

• 1 other identifier: FOUCH2012/10-3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A cohort of 20 patients aged 18 to 80 years (mean 28.35 years) of both genres females (65%) and males (35%) with 80 composite restorations were recruited at the Operative Dentistry Clinic at the Dental School of the University of Chile. All participants presented with marginal adaptation clinical features that deviated from the ideal and were rated Bravo according to the modified United States Public Health Service (USPHS) criteria for the sealing group and no treatment group. As a positive control were considered composites with alpha values in marginal adaptation. 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 registration form. The selection criteria are summarized below.

Conditions

Dental Restoration Failure

Keywords

composite; sealant; 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)

No treatment

NO INTERVENTION

The composite resin restorations had marginal defects, but were clinically acceptable, did not receive treatment

Positive control

NO INTERVENTION

Composite resins with alpha value in marginal adaptation criteria

Intervention

EXPERIMENTAL

For this group, defective areas were acid etched with 35% phosphoric acid for 15 seconds. A resin-based sealant (Clinpro Sealant, 3M ESPE) 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

Procedure: Sealant

Interventions

Sealant PROCEDURE

resin-based sealant (Clinpro Sealant, 3M ESPE)

Also known as: Clinpro Sealant, Alpha seal, Prime Dent

Intervention

Eligibility Criteria

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

You may qualify if:

• Patients with localized marginal deficiencies (Bravo Ryge Criterial) of composite restorations that were clinically judged to be suitable for sealing according to USPHS criteria.
• 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 are older than 18 years.
• Patients who agreed and signed a consent form for participating in the study.
• Area out of the restoration´s failure is in good condition.
• Composite resins with alpha value in adaptation marginal criterial

You may not qualify if:

• Patients with contra-indications for regular dental treatment based on their medical history.
• 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.
• Patients with localized marginal deficiencies \> 1 mm. and/or secondary caries adjacent to composite restorations , or major defects

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Facultad de Odontología Universidad de Chile

Santiago, Chile

Location

Related Publications (5)

• 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

• 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 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

• 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

• 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

MeSH Terms

Interventions

Clinpro Sealant

Study Officials

• Eduardo Fernández, Prof.

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 21, 2014
• Study Start: May 1, 2003
• Primary Completion: May 1, 2003
• Study Completion: December 1, 2013
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

CL (1)