Effect of Nano-structured Alumina Coating on the Bond Strength of Zirconia Resin-bonded Fixed Dental Prostheses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NAC, APA.
- Who it may be relevant to
- Registry conditions: Missing Incisors, Zirconia Surface Pretreatment, Children, Adults. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The purpose of this study is to evaluate the clinical outcome of resin-bonded fixed dental prostheses (RBFDPs) pretreated with nanostructured alumina coating (NAC). The study adopts a prospective, randomized, controlled, double-blind design contrasting the use of NAC to air-borne particle abrasion (APA) (control) as a surface pretreatment method of zirconia RBFDPs used for replacing missing central or lateral incisors. The primary outcome evaluated is the retention/survival of the zirconia RBFDPs pretreated with APA and NAC.
Detailed description
Zirconia resin-bonded fixed dental prostheses (RBFDPs) have been regarded as a promising minimally invasive alternative for the replacement of missing central and lateral incisors, offering several advantages to orthodontic space closure or tooth replacement with implant-supported restorations. Debonding of the zirconia RBFDPs represents the main technical complication since clinically established airborne particle abrasion (APA) of an inert zirconia surface does not always provide sufficient resin-bond strength. Further, APA can also impair the mechanical properties of zirconia restoration affecting its long-term success. Nano-structured alumina coating (NAC) presents an alternative non-invasive zirconia surface pretreatment. The aim of this randomized controlled clinical trial is to study the effect of NAC coated bonding surface of zirconia RBFDPs affecting its debonding and clinical survival rate.
The study adopts a prospective, randomized, controlled, double-blind design contrasting the use of NAC to air-borne particle abrasion (APA) as a surface pretreatment method of zirconia RBFDPs. Healthy patients in need of a missing central or lateral incisor replacement are screened and rated to be eligible by two calibrated dentists. RBFDPs are randomly allocated into two groups and inserted by the same operator. The first group, where the bonding surface is pretreated with APA serves a control group. In the second group the restorations are pretreated with NAC. The participants and the operator are blinded to the group assignment in a double-blinded trial design. The primary outcome evaluated is the retention/survival of the RBFDP. Non-parametric tests and Kaplan-Meyer analysis will be used to determine differences between both study groups.
Interventions
- Other NAC
Pretreatment of zirconia RBFDP with nanostructured alumina coating after milling of RBFDP's framework - Other APA
Air-borne particle abrasion of zirconia RBFDPs prior to bonding
Primary outcome measures
- Survival rate of zirconia RBFDPs [Time frame: From baseline through study completion, an average of 1 year]
Secondary outcome measures (6)
- Porcelain chipping [Time frame: From baseline through study completion, an average of 1 year]
- Zirconia framework fracture [Time frame: From baseline through study completion, an average of 1 year]
- Gingivitis [Time frame: From baseline through study completion, an average of 1 year]
- Parodontitis [Time frame: From baseline through study completion, an average of 1 year]
- Marginal leakage [Time frame: From baseline through study completion, an average of 1 year]
- Secondary caries [Time frame: From baseline through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
1\. Patients with missing central or lateral incisor
Exclusion criteria
- inadequate edentulous space for the pontic
- signs of bruxism
- abutment tooth with active periodontal or periapical disease
- inadequate enamel bonding surface of the abutment tooth
- inadequate interocclusal space for a retainer wing and a proximal connector
- pontic guidance
- physical or psychological disease likely to interfere with normal conduct of the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Slovenia · 1 center
- Medical Faculty - University of Ljubljana Ljubljana — Ljubljana
Identifiers
NCT: NCT04693949 · Adhesion of RBFDPs