Impact of Patients Risk Factors on the Longevity of Aesthetic Restorations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-10

Study Completion Date

2022-01-10

Brief Summary

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The objective of this double-blind randomized clinical trial is to evaluate the influence of caries risk, occlusal stress and missing teeth on anterior restorations over a 10 years follow up period. 300 teeth will be randomized according to two adhesive systems: Single Bond 2 and Single Bond Universal (3M ESPE); and two composite resins: nanoparticulated (Filtek ™ Z-350- 3M ESPE) and nanohybrid (IPS Empress Direct - Ivoclar Vivadent). The randomization will be stratified according to the risk of caries and cavity type. The primary outcomes will be longevity, annual failure rate (AFR) and the success of the restorations, and the secondary outcome will be causes for restorations' failure.

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Detailed Description

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Conditions

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Dental Restorations Longevity Dental Restoration Failure Esthetics, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a prospective randomized clinical trial, triple-blind, (patients, investigator and clinical evaluator) with parallel groups. After completing the ICDAS (International Caries Detection and Assessment), clinical occlusal stress examination and questionnaire application on occlusal stress, patients will be randomly divided into two types of dental adhesives and two types of composite resin. Randomization will be stratified according to the risk of caries determined by the ICDAS and the type of cavity to be filled. Operators (Master students and undergraduate students from the last year of the School of Dentistry, Federal University of Pelotas) will place the restorations supervised by highly trained clinicians.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a self-etching dental adhesive (SingleBond Universal, 3M ESPE), selective enamel etching, and use of a nanoparticulated composite (Z350, 3M ESPE)

Intervention Type PROCEDURE

Restorations with nanoparticulated composites and total-etch adhesives

The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a total-etching dental adhesive (SingleBond 2, 3M ESPE), and use of a nanoparticulated composite (Z350, 3M ESPE)

Intervention Type PROCEDURE

Restorations with nanohybrid composites and self etch adhesives

The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a self-etching dental adhesive (SingleBond Universal, 3M ESPE), selective enamel etching, and use of a nanohybrid composite (IPS Empress Direct, Ivoclar Vivadent).

Intervention Type PROCEDURE

Restorations with nanohybrid composites and total-etch adhesives

The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a total-etching dental adhesive (SingleBond 2, 3M ESPE), and use of a nanohybrid composite (IPS Empress Direct, Ivoclar Vivadent).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with restorative needs in anterior teeth;
* Patients able to understand and sign the informed consent form;
* Patients willing to return to follow up.

Exclusion Criteria

* Patients who had a need for Class III and Class IV restorations that did not involve at least 1/3 of the tooth;
* Patients under orthodontic treatment;
* Patients with a compromised general health condition, presenting a greater risk than ASA II, according to the ASA-PS (American Society of Anesthesiologists - Physical Status);
* Patients who had no occlusal contact with an opposing tooth and/or crown;
* Patient with absence of bilateral balanced occlusion;
* Patient with deep caries lesions in close contact with the dental pulp and in need of expectant treatment or direct pulp capping;
* Patients with post-retained need in anterior teeth.

Minimum Eligible Age

9 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes