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NCT Number: NCT04693949

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Faculty - University of Ljubljana Ljubljana

Ljubljana, 1000, Slovenia

Location status: Recruiting

Location contact

Tine Malgaj, DMD

CONTACT

[email protected]

+386 31 410140

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

NAC

Other

Pretreatment of zirconia RBFDP with nanostructured alumina coating after milling of RBFDP's framework

APA

Other

Air-borne particle abrasion of zirconia RBFDPs prior to bonding

Primary outcomes

  1. 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

Secondary outcomes

  1. Porcelain chipping

    Time frame: From baseline through study completion, an average of 1 year

    Porcelain chipping

  2. Zirconia framework fracture

    Time frame: From baseline through study completion, an average of 1 year

    Zirconia framework fracture

  3. Gingivitis

    Time frame: From baseline through study completion, an average of 1 year

    Visual and tactile inspection of gingiva

  4. Parodontitis

    Time frame: From baseline through study completion, an average of 1 year

    Gingival sulcus depth measurement

  5. Marginal leakage

    Time frame: From baseline through study completion, an average of 1 year

    Discoloration of a restoration margin

  6. Secondary caries

    Time frame: From baseline through study completion, an average of 1 year

    Caries between the tooth and restoration margin

Study contacts

Contact information is provided by the study sponsor or research team.

Tine Malgaj, DMD

CONTACT

[email protected]

+386 31 410140

Sponsors and collaborators

Lead sponsor

University of Ljubljana, Faculty of Medicine

Other

Registry information

Important dates

Study start
2018
Primary completion
2027
Study completion
2030
First posted
Jan 5, 2021
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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