Resin Bulkfill Dual-Cured of Proximal Restoration. Clinical Trial

NCT05013853 | Completed DMC

• 1 other identifier: PROPRGFO_002019.25.
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Restoration; Dental Caries

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Resin Z350 of proximal posterior teeth

ACTIVE COMPARATOR

Restorative with Z350 composite of proximal caries lesions or restorations replacement

Procedure: Restoration teeth

Resin Tetric N Ceram Bulkfill of proximal posterior teeth

ACTIVE COMPARATOR

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

Procedure: Restoration teeth

Resin Fill Up! of proximal posterior teeth

EXPERIMENTAL

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

Procedure: Restoration teeth

Interventions

Restoration teeth PROCEDURE

Remove caries and restore with resin composite

Resin Fill Up! of proximal posterior teeth; Resin Tetric N Ceram Bulkfill of proximal posterior teeth; Resin Z350 of proximal posterior teeth

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Andres Bello: lead

Study Sites (1)

Patricio Vildosola Grez

Santiago, Santiago Metropolitan, 7510583, Chile

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Patricio Vildosola

  Universidad Andre Bello

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 19, 2021
• Study Start: May 15, 2019
• Primary Completion: February 10, 2020
• Study Completion: December 30, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)