Resin Bulkfill Dual-Cured of Proximal Restoration. Clinical Trial

Clinical Performance Resin Bulk Fill Dual-cured of Posterior Restorations: Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries; Dental Restoration
• Intervention / Treatment: Procedure: Restoration teeth

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile, 7510583
      • Patricio Vildosola Grez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Resin Z350 of proximal posterior teeth; Restorative with Z350 composite of proximal caries lesions or restorations replacement	Procedure: Restoration teeth; Remove caries and restore with resin composite
Active Comparator: Resin Tetric N Ceram Bulkfill of proximal posterior teeth; Restorative with Tetric N Ceram Bulkfill composite of proximal caries lesions or restorations replacement	Procedure: Restoration teeth; Remove caries and restore with resin composite
Experimental: Resin Fill Up! of proximal posterior teeth; Restorative with Fill Up! composite of proximal caries lesions or restorations replacement	Procedure: Restoration teeth; Remove caries and restore with resin composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare clinical performance restorations	Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI system , Unit is Ranking system has 5 scores for each different criterion. Either restoration is clinically 1: excellent, 2: good, 3:sufficient, 4: unsatisfactory, 5: clinically poor.	Baseline
Compare clinical performance restorations	Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI system , Unit is Ranking system has 5 scores for each different criterion. Either restoration is clinically 1: excellent, 2: good, 3:sufficient, 4: unsatisfactory, 5: clinically poor.	6 months
Compare clinical performance restorations	Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI system , Unit is Ranking system has 5 scores for each different criterion. Either restoration is clinically 1: excellent, 2: good, 3:sufficient, 4: unsatisfactory, 5: clinically poor.	12 months
Compare clinical performance restorations	Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI system , Unit is Ranking system has 5 scores for each different criterion. Either restoration is clinically 1: excellent, 2: good, 3:sufficient, 4: unsatisfactory, 5: clinically poor.	18 months
Compare clinical performance restorations	Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI system , Unit is Ranking system has 5 scores for each different criterion. Either restoration is clinically 1: excellent, 2: good, 3:sufficient, 4: unsatisfactory, 5: clinically poor.	24 months

Collaborators and Investigators

• Sponsor: Universidad Nacional Andres Bello
• Investigators: Principal Investigator: Patricio Vildosola, Universidad Andre Bello

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): February 10, 2020
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: PROPRGFO_002019.25.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No