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

May 10, 2023 updated by: University of Ljubljana, Faculty of Medicine

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Recruiting
        • Medical Faculty - University of Ljubljana Ljubljana
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: APA
Air-borne particle abrasion of zirconia RBFDPs prior to bonding
Other: APA
Air-borne particle abrasion of zirconia RBFDPs prior to bonding
Experimental: NAC
Pretreatment of zirconia RBFDP with nanostructured alumina coating after milling of RBFDP's framework
Other: NAC
Pretreatment of zirconia RBFDP with nanostructured alumina coating after milling of RBFDP's framework

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate of zirconia RBFDPs
Time Frame: From baseline through study completion, an average of 1 year
Survival rate is defined by debonding or restoration loss
From baseline through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ljubljana, Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2018

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

December 29, 2020

First Submitted That Met QC Criteria

December 30, 2020

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Adhesion of RBFDPs

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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