Clinical trial NCT03834636: Impact of Patients Risk Factors on the Longevity of Aesthetic Restorations
Official title: Impact of Patients Risk Factors, Type of Dental Material and Dental Technique on the Longevity of Aesthetic Dental Restorations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dental Restorations Longevity
Dental Restoration Failure
Esthetics, Dental
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 110
Sex: ALL
Minimum age (years): 9
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Survival of the restorations
timeFrame: Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.
measure: Success of the restorations
timeFrame: Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.
Secondary outcomes:
measure: Patient satisfaction with the treatment
timeFrame: Changes in the patient's satisfaction status compared to baseline will be assessed yearly up to 10 years.
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Federal Univeristy of Pelotas
state: RS
Study officials:
affiliation: Graduate Program in Dentistry - Federal University of Pelotas
name: Maximiliano S Cenci
role: PRINCIPAL_INVESTIGATOR
References: