Impact of Patients Risk Factors on the Longevity of Aesthetic Restorations

Dental Restoration Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03834636
• Other study ID #: PPGO 029
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 10, 2012
• Est. completion date: January 10, 2022

Study information

• Verified date: February 2019
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: January 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Restoration Failure
• Dental Restorations Longevity
• Esthetics, Dental

Intervention

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)
• 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)
• 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).
• 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).

Locations

Country	Name	City	State
Brazil	Federal Univeristy of Pelotas	Pelotas	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.