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

• Sponsor: University of Ljubljana, Faculty of Medicine (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04693949
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 73.9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Missing Incisors; Zirconia Surface Pretreatment; Children; Adults; Debonding	Other: NAC; Other: APA	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a single-centre, prospective, randomized, controlled, double-blind clinical trial.This is a single-centre, prospective, randomized, controlled, double-blind clinical trial.
• Masking: Double (Participant, Care Provider)
• Masking Description: Prior to the beginning of the study 50 identification numbers were divided into 2 groups on the basis of a computer generated tables (www.randomization.com). The two groups were then randomly allocated to the zirconia pretreatment method using a random generator. The randomization process was conducted by a staff member not involved in the research protocol. For each identification number, the selected pretreatment is written on a card contained in an opaque sealed envelope. The envelopes are stored by a study supervisor. Each envelope is opened by a dental technician after the RBFDP's zirconia framework is milled and then once again stored by the study supervisor until the conclusion of a study.
• Primary Purpose: Treatment
• Official Title: Effect of Nano-structured Alumina Coating on the Bond Strength of Zirconia Resin-bonded Fixed Dental Prostheses
• Actual Study Start Date: Jan 3, 2018
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Porcelain chipping [From baseline through study completion, an average of 1 year]

   Porcelain chipping

2. Zirconia framework fracture [From baseline through study completion, an average of 1 year]

   Zirconia framework fracture

3. Gingivitis [From baseline through study completion, an average of 1 year]

   Visual and tactile inspection of gingiva

4. Parodontitis [From baseline through study completion, an average of 1 year]

   Gingival sulcus depth measurement

5. Marginal leakage [From baseline through study completion, an average of 1 year]

   Discoloration of a restoration margin

6. Secondary caries [From baseline through study completion, an average of 1 year]

   Caries between the tooth and restoration margin

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Faculty - University of Ljubljana Ljubljana	Ljubljana		Slovenia	1000

Sponsors and Collaborators

• University of Ljubljana, Faculty of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Ljubljana, Faculty of Medicine
• ClinicalTrials.gov Identifier: NCT04693949
• Other Study ID Numbers: Adhesion of RBFDPs
• First Posted: Jan 5, 2021
• Last Update Posted: May 19, 2022
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Ljubljana, Faculty of Medicine: Airborne particle abrasion; Nanostructured alumina coating; Resin-bonded fixed dental prostheses

Study Results

No Results Posted as of May 19, 2022