Resin Bulkfill Dual-Cured of Proximal Restoration. Clinical Trial

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05013853
• Other study ID #: PROPRGFO_002019.25.
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: May 2022
• Source: Universidad Nacional Andres Bello
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 30, 2021
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Restoration

Intervention

Procedure:
• Restoration teeth
Remove caries and restore with resin composite

Locations

Country	Name	City	State
Chile	Patricio Vildosola Grez	Santiago	Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional Andres Bello

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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