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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-01

Study Completion Date

2017-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Increasing Composite Restorations Sealants

NCT02119195

Dental Restoration Failure

COMPLETED NA

Can Repair Increase the Useful Life of Composite Resins?

NCT02043873

Replacement Repair Composites Restorations

COMPLETED

Composite Resins Reconditioned, Behavior and Survival: Clinical Follow-up 10 Years

NCT02222701

Unsatisfactory Restoration of Tooth

COMPLETED

10-years Clinical Trial of Sealed of Margin Failures

NCT02075801

Dental Caries Secondary to Acquired Defects of Tooth Structure

COMPLETED

Impact of Patients Risk Factors on the Longevity of Aesthetic Restorations

NCT03834636

Dental Restorations Longevity Dental Restoration Failure Esthetics, Dental

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Caries Minimally Invasive Repair

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Sealing margins with flow composite

Intervention Type PROCEDURE

Seal the margin of restoration with Composite flow with nanofiller

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

Group Type ACTIVE_COMPARATOR

Sealing margins with seal

Intervention Type PROCEDURE

Seal the margin of restoration with sealant without filler

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sealing margins with flow composite

Seal the margin of restoration with Composite flow with nanofiller

Intervention Type PROCEDURE

Sealing margins with seal

Seal the margin of restoration with sealant without filler

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes