Resin Bulkfill Dual-Cured of Proximal Restoration. Clinical Trial

NCT ID: NCT05013853

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2021-12-30

Brief Summary

Objective: To evaluate the immediate clinical performance using FDI criteria in occlusal and proximal lesions restored with dual polymerization bulkfill composite resin.

Materials and methods: Experimental, clinical, controlled, randomized, double-blind study. For the evaluation of Fill-up! (FU) will be clinically compared to the control groups of a conventional Tetric N-Ceram (TB) RBK and Filtek z350 (z350) conventional composite resin. The adhesive process will be carried out under absolute isolation, of selective etching of 37% orthophosphoric acid enamel before applying the respective adhesive according to the trademark of the composite resins. The evaluation will be to 30 days, 6, 12, 18 and 24 months using the modified FDI criteria of postoperative sensitivity, marginal staining, color, marginal adaptation and anatomy, being 1: Excellent, 2: Good, 3: Fair, 4: unsatisfactory and 5: unacceptable. The non-parametric Kruskal Wallis test and Friedman (95% significance) used to compare the criteria.

Detailed Description

Prior to the removal of carious lesions, the tooth will be first anesthetized. The lesion areas will be prepared with a diamond rotary instrument (801G.FG.016, Jota AG Rotary Instruments - Switzerland) at high speed and under refrigeration with abundant water. Only damaged tissue conservatively removed. The corresponding measurements it recorded with a millimeter probe (Hu Friedy®, North Carolina, Chicago, USA). Prior to the insertion of the material, the sectional matrix system and the palodent type matrix system and with a wooden wedge will be used. The manufacturer's instructions for each brand of composite resin will be followed. It conditioned with 37% phosphoric acid only in enamel, wash for twice as long and dried. The corresponding adhesive will be used f Single Bond Universal adhesive (3M-Espe, ST. Paul, MN, USA) applied for the z350 group, Tetric N-Bond Universal adhesive (Ivoclar Vivadent AG, Schaan, Liechtenstein) for TB group and One Coat adhesive (Còltene, Whaladent Inc.) for FBK group. In the case of the FBK group, a final layer of Brilliant EverGlow composite resin (Còltene, Whaladent inc) will be added. Figure 3 Photopolymerization procedures performed using an LED light source with a minimum power of 1,100 mW / cm2 (Bluephase Style, Ivoclar Vivadent, AG, Schaan, Liechtenstein). The centric and eccentric occlusal contacts were verified and adjusted. For the finishing and polishing of both protocols, flexible discs (3M ESPE, St. Paul, USA) and the Enhance system (Dentsply, Petrópolis, RJ, Brazil) were used.

Conditions

Dental Restoration; Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Resin Z350 of proximal posterior teeth

Restorative with Z350 composite of proximal caries lesions or restorations replacement

Group Type: ACTIVE_COMPARATOR

Restoration teeth

Intervention Type: PROCEDURE

Remove caries and restore with resin composite

Resin Tetric N Ceram Bulkfill of proximal posterior teeth

Restorative with Tetric N Ceram Bulkfill composite of proximal caries lesions or restorations replacement

Group Type: ACTIVE_COMPARATOR

Restoration teeth

Intervention Type: PROCEDURE

Remove caries and restore with resin composite

Resin Fill Up! of proximal posterior teeth

Restorative with Fill Up! composite of proximal caries lesions or restorations replacement

Group Type: EXPERIMENTAL

Restoration teeth

Intervention Type: PROCEDURE

Remove caries and restore with resin composite

Interventions

Restoration teeth

Remove caries and restore with resin composite

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers,
• high cariogenic risk,
• availability for clinical follow-up,
• have at least 3 teeth with occlusal and / or proximal carious lesions of molars or premolars with occlusal and proximal contact,
• lesions less than 1/3 of inter-cuspal distance and depth> 3 mm in the cervical-occlusal direction and margin on enamel

Exclusion Criteria

• Impossibility wash their teeth
• evidence of xerostomia
• uncontrolled periodontal disease,
• pregnant or breastfeeding
• bruxism or with temporomandibular disorder
• history of allergy to acrylic or its derivatives,
• portador of removable prostheses endodontically treated teeth
• cracked teeth and periapical pathology or pulp pathology symptoms.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Nacional Andres Bello

OTHER

Sponsor Role: lead

Responsible Party

Patricio Vildosola Grez

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricio Vildosola

Role: PRINCIPAL_INVESTIGATOR

Universidad Andre Bello

Locations

Patricio Vildosola Grez

Santiago, Santiago Metropolitan, Chile

Countries

Chile

Other Identifiers

PROPRGFO_002019.25.

Identifier Type: -

Identifier Source: org_study_id