Resin Bulkfill Dual-Cured of Proximal Restoration. Clinical Trial
Primary Purpose
Dental Restoration, Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Restoration teeth
Sponsored by
About this trial
This is an interventional treatment trial for Dental Restoration
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.
Sites / Locations
- Patricio Vildosola Grez
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Resin Z350 of proximal posterior teeth
Resin Tetric N Ceram Bulkfill of proximal posterior teeth
Resin Fill Up! of proximal posterior teeth
Arm Description
Restorative with Z350 composite of proximal caries lesions or restorations replacement
Restorative with Tetric N Ceram Bulkfill composite of proximal caries lesions or restorations replacement
Restorative with Fill Up! composite of proximal caries lesions or restorations replacement
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05013853
First Posted
August 4, 2021
Last Updated
May 16, 2022
Sponsor
Universidad Nacional Andres Bello
1. Study Identification
Unique Protocol Identification Number
NCT05013853
Brief Title
Resin Bulkfill Dual-Cured of Proximal Restoration. Clinical Trial
Official Title
Clinical Performance Resin Bulk Fill Dual-cured of Posterior Restorations: Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional Andres Bello
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Restoration, Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resin Z350 of proximal posterior teeth
Arm Type
Active Comparator
Arm Description
Restorative with Z350 composite of proximal caries lesions or restorations replacement
Arm Title
Resin Tetric N Ceram Bulkfill of proximal posterior teeth
Arm Type
Active Comparator
Arm Description
Restorative with Tetric N Ceram Bulkfill composite of proximal caries lesions or restorations replacement
Arm Title
Resin Fill Up! of proximal posterior teeth
Arm Type
Experimental
Arm Description
Restorative with Fill Up! composite of proximal caries lesions or restorations replacement
Intervention Type
Procedure
Intervention Name(s)
Restoration teeth
Intervention Description
Remove caries and restore with resin composite
Primary Outcome Measure Information:
Title
Compare clinical performance restorations
Description
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.
Time Frame
Baseline
Title
Compare clinical performance restorations
Description
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.
Time Frame
6 months
Title
Compare clinical performance restorations
Description
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.
Time Frame
12 months
Title
Compare clinical performance restorations
Description
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.
Time Frame
18 months
Title
Compare clinical performance restorations
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricio Vildosola
Organizational Affiliation
Universidad Andre Bello
Official's Role
Principal Investigator
Facility Information:
Facility Name
Patricio Vildosola Grez
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7510583
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
No
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Resin Bulkfill Dual-Cured of Proximal Restoration. Clinical Trial
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