Sealing Defective Margins of Composite Restorations With Fluid Composite Resin Nanofiller Reinforced (SEAL2)
Primary Purpose
Dental Caries, Minimally Invasive, Repair
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sealing margins with flow composite
Sealing margins with seal
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
Eligibility Criteria
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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
resin composite with nanofiller.
sealant based on resin
Control
Arm Description
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
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
The restorations were evaluated without treatment about defective restoration that was considered clinically acceptable.
Outcomes
Primary Outcome Measures
Marginal adaptation
( mm of bridge between tooth and restorations )
Marginal staining,
( + >50% diameter / - <50% diameter)
Retention of seal ( is present + / was loose -)
Loss of restoration
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03214445
Brief Title
Sealing Defective Margins of Composite Restorations With Fluid Composite Resin Nanofiller Reinforced
Acronym
SEAL2
Official Title
Reparación y Sellado de Restauraciones de Amalgama y Resinas Compuestas Para el Incremento de Su Longevidad Repair and Sealing of Amalgam and Composite Resins to Increase of Longevity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
May 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Minimally Invasive, Repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
resin composite with nanofiller.
Arm Type
Experimental
Arm Description
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
Arm Title
sealant based on resin
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
The restorations were evaluated without treatment about defective restoration that was considered clinically acceptable.
Intervention Type
Procedure
Intervention Name(s)
Sealing margins with flow composite
Intervention Description
Seal the margin of restoration with Composite flow with nanofiller
Intervention Type
Procedure
Intervention Name(s)
Sealing margins with seal
Intervention Description
Seal the margin of restoration with sealant without filler
Primary Outcome Measure Information:
Title
Marginal adaptation
Description
( mm of bridge between tooth and restorations )
Time Frame
6 month
Title
Marginal staining,
Description
( + >50% diameter / - <50% diameter)
Time Frame
4 years
Title
Retention of seal ( is present + / was loose -)
Description
Loss of restoration
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Martin
Organizational Affiliation
U de Chile
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25535778
Citation
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.
Results Reference
background
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Sealing Defective Margins of Composite Restorations With Fluid Composite Resin Nanofiller Reinforced
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