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

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04693949
• Other study ID #: Adhesion of RBFDPs
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: March 1, 2024

Study information

• Verified date: May 2023
• Source: University of Ljubljana, Faculty of Medicine
• Contact: Tine Malgaj, DMD
• Phone: +386 31 410140
• Email: tine.malgaj[@]mf.uni-lj.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adults
• Children
• Debonding
• Missing Incisors
• Zirconia Surface Pretreatment

Intervention

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

Locations

Country	Name	City	State
Slovenia	Medical Faculty - University of Ljubljana Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University of Ljubljana, Faculty of Medicine

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate of zirconia RBFDPs	Survival rate is defined by debonding or restoration loss	From baseline through study completion, an average of 1 year
Secondary	Porcelain chipping	Porcelain chipping	From baseline through study completion, an average of 1 year
Secondary	Zirconia framework fracture	Zirconia framework fracture	From baseline through study completion, an average of 1 year
Secondary	Gingivitis	Visual and tactile inspection of gingiva	From baseline through study completion, an average of 1 year
Secondary	Parodontitis	Gingival sulcus depth measurement	From baseline through study completion, an average of 1 year
Secondary	Marginal leakage	Discoloration of a restoration margin	From baseline through study completion, an average of 1 year
Secondary	Secondary caries	Caries between the tooth and restoration margin	From baseline through study completion, an average of 1 year