Impact of Patients Risk Factors on the Longevity of Aesthetic Restorations

Federal University of Pelotas

Status and phase: Unknown; Phase 3

Conditions: Dental Restoration Failure; Dental Restorations Longevity; Esthetics, Dental

Treatments: Procedure: Restorations with nanoparticulated composites and self etch adhesives; Procedure: Restorations with nanohybrid composites and total-etch adhesives; Procedure: Restorations with nanoparticulated composites and total-etch adhesives; Procedure: Restorations with nanohybrid composites and self etch adhesives

Study type: Interventional

Funder types: Other

Identifiers

NCT03834636

PPGO 029

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 9 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 4 patient groups

Nanoparticulated composite - self-etch

Active Comparator group

Treatment:

Procedure: Restorations with nanoparticulated composites and self etch adhesives

Nanoparticulated composite - total-etch

Active Comparator group

Treatment:

Procedure: Restorations with nanoparticulated composites and total-etch adhesives

Nanohybrid composite - self-etch

Active Comparator group

Treatment:

Procedure: Restorations with nanohybrid composites and self etch adhesives

Nanohybrid composite - total-etch

Active Comparator group

Treatment:

Procedure: Restorations with nanohybrid composites and total-etch adhesives