Effect of Nano-structured Alumina Coating on the Bond Strength of Zirconia Resin-bonded Fixed Dental Prostheses

Not Applicable

Recruiting

• Conditions: Missing Incisors; Zirconia Surface Pretreatment; Debonding; Children; Adults
• Interventions: Other: APA; Other: NAC

• Registration Number: NCT04693949
• Lead Sponsor: University of Ljubljana, Faculty of Medicine

Brief Summary

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.

Study Timeline

• Study Start: 2018-01-03
• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2021-01-05
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11
• Primary Completion: 2024-01-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients with missing central or lateral incisor

Exclusion Criteria

1. inadequate edentulous space for the pontic
2. signs of bruxism
3. abutment tooth with active periodontal or periapical disease
4. inadequate enamel bonding surface of the abutment tooth
5. inadequate interocclusal space for a retainer wing and a proximal connector
6. pontic guidance
7. physical or psychological disease likely to interfere with normal conduct of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APA	APA	Air-borne particle abrasion of zirconia RBFDPs prior to bonding
NAC	NAC	Pretreatment of zirconia RBFDP with nanostructured alumina coating after milling of RBFDP's framework

Primary Outcome Measures

Name	Time	Method
Survival rate of zirconia RBFDPs	From baseline through study completion, an average of 1 year	Survival rate is defined by debonding or restoration loss

Secondary Outcome Measures

Name	Time	Method
Gingivitis	From baseline through study completion, an average of 1 year	Visual and tactile inspection of gingiva
Parodontitis	From baseline through study completion, an average of 1 year	Gingival sulcus depth measurement
Zirconia framework fracture	From baseline through study completion, an average of 1 year	Zirconia framework fracture
Marginal leakage	From baseline through study completion, an average of 1 year	Discoloration of a restoration margin
Secondary caries	From baseline through study completion, an average of 1 year	Caries between the tooth and restoration margin
Porcelain chipping	From baseline through study completion, an average of 1 year	Porcelain chipping

Trial Locations

Locations (1)

Medical Faculty - University of Ljubljana Ljubljana; 🇸🇮 Ljubljana, Slovenia