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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Medical Faculty - University of Ljubljana Ljubljana
Ljubljana, Slovenia
RECRUITINGSurvival rate of zirconia RBFDPs
Survival rate is defined by debonding or restoration loss
Time frame: From baseline through study completion, an average of 1 year
Porcelain chipping
Porcelain chipping
Time frame: From baseline through study completion, an average of 1 year
Zirconia framework fracture
Zirconia framework fracture
Time frame: From baseline through study completion, an average of 1 year
Gingivitis
Visual and tactile inspection of gingiva
Time frame: From baseline through study completion, an average of 1 year
Parodontitis
Gingival sulcus depth measurement
Time frame: From baseline through study completion, an average of 1 year
Marginal leakage
Discoloration of a restoration margin
Time frame: From baseline through study completion, an average of 1 year
Secondary caries
Caries between the tooth and restoration margin
Time frame: From baseline through study completion, an average of 1 year
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