NCT04693949

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

6 years

First QC Date

December 29, 2020

Last Update Submit

May 10, 2023

Conditions

Missing IncisorsZirconia Surface PretreatmentChildrenAdultsDebonding

Keywords

Airborne particle abrasionNanostructured alumina coatingResin-bonded fixed dental prostheses

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Porcelain chipping

    From baseline through study completion, an average of 1 year

  • Zirconia framework fracture

    From baseline through study completion, an average of 1 year

  • Gingivitis

    From baseline through study completion, an average of 1 year

  • Parodontitis

    From baseline through study completion, an average of 1 year

  • Marginal leakage

    From baseline through study completion, an average of 1 year

  • +1 more secondary outcomes

Study Arms (2)

APA

ACTIVE COMPARATOR

Air-borne particle abrasion of zirconia RBFDPs prior to bonding

Other: APA

NAC

EXPERIMENTAL

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

Other: NAC

Interventions

NACOTHER

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

NAC
APAOTHER

Air-borne particle abrasion of zirconia RBFDPs prior to bonding

APA

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients with missing central or lateral incisor

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Faculty - University of Ljubljana Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Central Study Contacts

Tine Malgaj, DMD

CONTACT

+386 31 410140tine.malgaj@mf.uni-lj.si

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a single-centre, prospective, randomized, controlled, double-blind clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2020

First Posted

January 5, 2021

Study Start

January 3, 2018

Primary Completion

January 1, 2024

Study Completion

March 1, 2024

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations

SL(1)