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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05013853
Other study ID # PROPRGFO_002019.25.
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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