Dental Caries Clinical Trial
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
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
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.
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