Impact of Patients Risk Factors on the Longevity of Aesthetic Restorations

Impact of Patients Risk Factors, Type of Dental Material and Dental Technique on the Longevity of Aesthetic Dental Restorations

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.

Study Overview

• Status: Unknown
• Conditions: Dental Restoration Failure; Esthetics, Dental; Dental Restorations Longevity
• Intervention / Treatment: Procedure: Restorations with nanoparticulated composites and self etch adhesives; Procedure: Restorations with nanoparticulated composites and total-etch adhesives; Procedure: Restorations with nanohybrid composites and self etch adhesives; Procedure: Restorations with nanohybrid composites and total-etch adhesives

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Pelotas, RS, Brazil, 96015080
      • Federal Univeristy of Pelotas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nanoparticulated composite - self-etch	Procedure: Restorations with nanoparticulated 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 nanoparticulated composite (Z350, 3M ESPE)
Active Comparator: Nanoparticulated composite - total-etch	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)
Active Comparator: Nanohybrid composite - self-etch	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).
Active Comparator: Nanohybrid composite - total-etch	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of the restorations	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.	Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.
Success of the restorations	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.	Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of Pelotas
• Investigators: Principal Investigator: Maximiliano S Cenci, Graduate Program in Dentistry - Federal University of Pelotas

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2012
• Primary Completion (Anticipated): January 10, 2022
• Study Completion (Anticipated): January 10, 2022

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 8, 2019

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PPGO 029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No