Impact of Patients Risk Factors on the Longevity of Aesthetic Restorations

Phase 3

• Conditions: Esthetics, Dental; Dental Restorations Longevity; Dental Restoration Failure
• Interventions: Procedure: Restorations with nanoparticulated composites and total-etch adhesives; Procedure: Restorations with nanohybrid composites and total-etch adhesives; Procedure: Restorations with nanoparticulated composites and self etch adhesives; Procedure: Restorations with nanohybrid composites and self etch adhesives

• Registration Number: NCT03834636
• Lead Sponsor: Federal University of Pelotas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-10
• Status Verified: 2019-02
• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-07
• Last Update Submitted: 2019-02-07
• Study First Posted: 2019-02-08
• Last Update Posted: 2019-02-08
• Primary Completion: 2022-01-10
• Study Completion: 2022-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nanoparticulated composite - total-etch	Restorations with nanoparticulated composites and total-etch adhesives	-
Nanohybrid composite - total-etch	Restorations with nanohybrid composites and total-etch adhesives	-
Nanoparticulated composite - self-etch	Restorations with nanoparticulated composites and self etch adhesives	-
Nanohybrid composite - self-etch	Restorations with nanohybrid composites and self etch adhesives	-

Primary Outcome Measures

Name	Time	Method
Success of the restorations	Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.	Success of the restoration is defined as any case where the restoration remains functional in the mouth at the time of evaluation, without any need of new interventions, and attending the patients demands. The restorations were evaluated shortly after baseline and in prospective periods through a direct clinical inspection, with an explorer probe and a clinical mirror, according to the criteria for clinical evaluation of restorations proposed by the FDI (International Dental Federation) (Hickel et al., 2010), the risks of caries and occlusal stress were also evaluated again.
Survival of the restorations	Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.	Survival of the restoration is defined as any case where the restoration remains functional in the mouth at the time of evaluation, regardless of need of small interventions, such as repair or refurbishment. The restorations were evaluated shortly after baseline and in prospective periods through a direct clinical inspection, with an explorer probe and a clinical mirror, according to the criteria for clinical evaluation of restorations proposed by the FDI (International Dental Federation) (Hickel et al., 2010), the risks of caries and occlusal stress were also evaluated again.; Two trained and calibrated evaluators, unrelated to making the restorations, blinded to the type of material used, independently performed the clinical evaluations.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with the treatment	Changes in the patient's satisfaction status compared to baseline will be assessed yearly up to 10 years.	Patient satisfaction will be recorded with FDI criteria

Trial Locations

Locations (1)

Federal Univeristy of Pelotas; 🇧🇷 Pelotas, RS, Brazil