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CompletedNCT03214445SEAL2Updated Jul 11, 2017

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

An interventional study of Sealing margins with flow composite and Sealing margins with seal in Dental Caries, Minimally Invasive and Repair, sponsored by University of Chile. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-11.

Sponsored by University of Chile · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Mar 2015, registered May 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

This is a 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.

Inclusion criteria:

  • 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.

Exclusion criteria:

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

The volunteers were informed of the objectives and risks of treatment, as well as the freedom to leave the study. It explained in detail the clinical procedure which was submitted and proceeded to sign the informed consent according to the rules of the Ethics Committee of the Faculty of Dentistry of the University of Chile.

Then were assigned the sample within 3 groups of randomly with software Eclipse SDK 4.2.1: (1) sealing with fluid composite resin restorations with nano filled and universal adhesive, (2) sealant adhesive based on resin composite resin with universal adhesive and (3) group control or untreated.

Initial examination Examination of patients was performed independently by two calibrated evaluators, in case of disagreement operators were consulted with a third operator, this in a clinical field well lit, with the tooth surface clean with brush of prophylaxis and water, for the clinical examination was used to mirror No 5 (Hu-Friedy Mfg. Co. Inc., Chicago, IL, USA), probe of caries straight with active diameter of 150 μm portion (Deppeler, Swiss Dental) and caries probe straight with active portion of diameter 250 μm (Deppeler, Swiss Dental), both indicated by the FDI. For an optimal value in the parameter of marginal adaptation, the gap should be a size less than or equal to the diameter of the active portion of the probes.

Procedure

Once selected patients and their restorations, were polished using aluminum oxide disks with complete series (Sof-Lex. 3M ESPE) and polished tips (Diacomp, Brasseler).

Each restoration to seal received an identification code, which was awarded randomly belong to an experimental group, as described previously. The tabulation and data of each treatment were conducted in the program Microsoft Excel 2011.

Software Cariogram was used to assess the parameters for the analysis of risk cariogenic: the experience of caries, diseases related, content diet, the frequency of diet, the quantity of plaque, fluor exposition , salivary secretion, capacity buffer and clinical judgment.

Treatment and clinical intervention groups

Group 1::Sealed with fluid resin composite with nanofiller.

Once cleaned the restoration with prophylaxis hard brush and water, at low speed. The procedure was performed under absolute isolation with a rubber dam and using ejector to remove saliva and excess water. Following the protocol of conditionate surface with orthophosphoric acid 35%, for 15 seconds, washed ( abundant water by 30 s) and dried with compressed air from the syringe for 15 s. Then proceeded with the application of adhesive (Single Bond Universal, 3M ESPE) with brush (Microbrush International, Grafton, USA) and friction against the surface for 20 seconds, dried for 5 seconds for evaporation of the solvent remaining and photopolymerized for 10 seconds, using light curing (2500 Curing light, 3M ESPE).

Applied in marginal defects of nanoparticle flowable composite resin (Filtek Flow Z350XT, 3M ESPE) with instrument for cement application of calcium hydroxide (PICH, Hu Friedy Mfg. Co Inc., Chicago, IL, USA), it is polymerized for 20 seconds (2500 Curing light, 3 M ESPE).

The occlusal checked was controlled with paper articulate with 200 microns of width (Bausch Articulating Papers, Inc., USA), occlusal adjustments and wear were carried out with a stone No. 3 high speed (SSWhite, USA).

Group 2: Sealed with sealant based on resin. Once cleaned the restoration with prophylaxis hard brush and water, at low speed. The procedure was performed under absolute isolation with a rubber dam and using ejector to remove saliva and excess water. Following the same Protocol of conditioning, this was done with orthophosphoric acid 35%, for 15 seconds, wash by 30 seconds and dried with compressed air from the syringe for 15 seconds. Then proceeded with the application of adhesive (Single Bond Universal, 3M ESPE) with brush (Microbrush International, Grafton, USA) and friction against the surface for 20 seconds, flow of air for 5 seconds for evaporation of the solvent remaining and polymerizing for 10 seconds, using light curing (2500 Curing light, 3M ESPE).

Applied in marginal defects sealant of pits and fissures based on composite resin (Clinpro Sealant, 3 M ESPE) instrument of cement application of calcium hydroxide (PICH, Hu Friedy Mfg. Co Inc., Chicago, IL, USA), polymerized for 20 seconds (2500 Curing light, 3 M ESPE).

The occlusal checked was controlled with paper articulate 200 microns width (Bausch Articulating Papers, Inc., USA), occlusal adjustments and wear were carried out with stone No. 3 high speed (SSWhite, USA).

Group 3: control. The restorations were evaluated without treatment about defective restoration that was considered clinically acceptable.

Evaluation of treatments

Clinical assessments were made at 6 and 12 months in the parameters marginal adaptation, marginal staining and secondary caries and sealant retention.

Examination was performed independently by two calibrated operators, in case of disagreement were consulted with a third operator, this in a clinical field well lit, with the clean tooth surface with brush of prophylaxis and water, for the clinical examination was used the same methodology and instrumentation that examination.

Analysis of the clinical performance of the treatment groups

To evaluate the behavior of these treatments, after 6 and 12 months, was made the comparison versus baseline, whose valuation assigned to the subsequent application of seal evaluation was 1 (FDI), with the current state of the restoration.

02

Conditions studied

  • Dental Caries
  • Minimally Invasive
  • Repair

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03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

University of Chile is the lead sponsor of 191 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    resin composite with nanofiller.

    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

  • Active comparator
    sealant based on resin

    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

  • No intervention
    Control

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

Interventions

  • ProcedureSealing margins with flow composite

    Seal the margin of restoration with Composite flow with nanofiller

  • ProcedureSealing margins with seal

    Seal the margin of restoration with sealant without filler

06

What researchers measure

Primary outcomes

  1. Marginal adaptation

    ( mm of bridge between tooth and restorations )

    Time frame: 6 month

  2. Marginal staining,

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

    Time frame: 4 years

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

    Loss of restoration

    Time frame: 4 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 25535778 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03214445
Lead sponsor
University of Chile
Responsible party
Eduardo Fernandez (Profesor, University of Chile) — Principal investigator
First posted
Jul 11, 2017
Start date
Mar 1, 2015
Primary completion
Dec 1, 2016
Completion
May 1, 2017
Last update
Jul 11, 2017

Study contacts

Javier Martin
study director · U de Chile

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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