Sealing Defective Margins of Composite Restorations With Fluid Composite Resin Nanofiller Reinforced

NCT03214445 | Completed DMC

• 1 other identifier: 2012/10
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

the patient (n=60), with at least 3 composite resins with marginal defects , randomized into 3 groups A=Sealed with flow composite reinforced with nanofiller , B= Sealed with resin sealant , and C=Control, without intervention , and then assessed by the FDI criteria for clinical performance and longevity of restorations

Conditions

Dental Caries; Minimally Invasive; Repair

Outcome Measures

Primary Outcomes (3)

• Marginal adaptation

  ( mm of bridge between tooth and restorations )

  6 month

• Marginal staining,

  ( + \>50% diameter / - \<50% diameter)

  4 years

• Retention of seal ( is present + / was loose -)

  Loss of restoration

  4 years

Study Arms (3)

resin composite with nanofiller.

EXPERIMENTAL

30 restorations of resin composite occlusal, molars or premolars, with values of 3 or 4 for the parameter marginal adaptation according to the FDI criteria randomized assigned in this group

Procedure: Sealing margins with flow composite

sealant based on resin

ACTIVE COMPARATOR

30 restorations of resin composite occlusal, molars or premolars, with values of 3 or 4 for the parameter marginal adaptation according to the FDI criteria randomized assigned in this group

Procedure: Sealing margins with seal

Control

NO INTERVENTION

The restorations were evaluated without treatment about defective restoration that was considered clinically acceptable.

Interventions

Sealing margins with flow composite PROCEDURE

Seal the margin of restoration with Composite flow with nanofiller

resin composite with nanofiller.

Sealing margins with seal PROCEDURE

Seal the margin of restoration with sealant without filler

sealant based on resin

Eligibility Criteria

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

You may qualify if:

• Age 18 or older
• High risk of caries.
• With restorations of resin composite occlusal, molars or premolars, with values of 3 or 4 for the parameter marginal adaptation according to the FDI criteria.

You may not qualify if:

• Patients with impossibility of mouth opening or dental treatments.
• Patients with allergies to any of the materials used.
• Presence of adjacent to the restoration or secondary caries.
• Patients with prior sealed of their restorations.

Sponsors & Collaborators

• University of Chile: lead

Related Publications (1)

• Fernandez E, Martin J, Vildosola P, Estay J, de Oliveira Junior OB, Gordan V, Mjor I, Gonzalez J, Loguercio AD, Moncada G. Sealing composite with defective margins, good care or over treatment? Results of a 10-year clinical trial. Oper Dent. 2015 Mar-Apr;40(2):144-52. doi: 10.2341/14-143-C. Epub 2014 Dec 23.

  PMID: 25535778 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Javier Martin

  U de Chile

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The evaluated restorations will be coded, and the data will be delivered in sealed envelopes without any identification of the patient, the data will be processed without identification of the groups. The sealant and the resin will be the same color so the evaluator will not be able to differentiate the treatments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor

Model Details: prospective, double blind randomized clinical trial under the recommendations of CONSORT. The statistical unit was considered the patient (n=60), with at least 3 composite resins with marginal defects , randomized into 3 groups A=Sealed with flow composite reinforced with nanofiller , B= Sealed with resin sealant , and C=Control, without intervention.

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: July 11, 2017
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share