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A Proof of Concept for All-ceramic Zirconia Resin Bonded Bridges for Canine, Premolar and Short Span Posterior Teeth

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ClinicalTrials.gov Identifier: NCT02793037
Recruitment Status : Enrolling by invitation
First Posted : June 8, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Michael G. Botelho, The University of Hong Kong

Brief Summary:

Trial Design - Objectives and Purpose The aim of this study is to perform a proof of concept for the successful retention and outcome measures of zirconia RBBs for the replacement of missing canine or posterior teeth (6-8mm span) and that they will exhibit similar survival rates (95%) as metal ceramic RBBs over 3 years and short term (Botelho 2006).

The use of monolithic extra-coronal zirconia RBBs in the posterior region does not appear to have been reported in the literature (A search pf Pub Med and Google Scholar has not shown any similar studies that have been published - pubmed.gov; Keywords: "zirconia", "resin", "clinical" assessed on 17/10/2015 AND google scholar; Keywords: "zirconia", "resin bonded fixed partial denture", "resin bonded fixed dental prosthesis", "Maryland", "resin bonded bridge" "posterior", "clinical") In addition, currently there appear to be no clinical trials planned or finished in this area (clinicaltrial.gov; Keywords: "zirconia", "resin" assessed on 17/10/2015) using zirconia RBBs in the posterior region. This reveals that there is a gap in the literature on the use of zirconia for replacing posterior teeth with such prostheses.

The primary outcome measures would be: success ie. prosthesis retention ie. does not fall out

The secondary outcome measures would be:

  • complications of the prosthesis such as tipping, drifting or fracture.
  • patient centered outcomes (satisfaction and oral health related quality of life) on the RBBs The hypothesis is that 2-unit cantilevered zirconia RBBs will be as successful as current data on 2-unit cantilevered metal-ceramic RBBs from this centre and that there will be no difference in the patient centered outcomes.

The Primary review appointments will be at 1, 6, 12, 24 and 36 months. However, longer term follow up will be performed and this centre has experience of such long term studies (9.5 years - Botelho 2014).

A randomized clinical trial (RCT) comparing to metal-ceramic RBBs will NOT be performed as the 5-year success rate of both metal-ceramic (Botelho 2006) and anterior zirconia (Sasse 2014) prosthesis were higher than 95% and this small differences would mean an unattainable large sample size in an equivalence test (Burns 2001).

Significance and implications Zirconia has significant strength and greater stiffness than base metal alloys and displays clinical outcomes comparable to metal-ceramic conventional crowns and bridges (Heintze 2010, Sailer 2007). Well polished zirconia has been observed to have lower wear rates than porcelain (Stober 2014) Zirconia RBBs for posterior tooth replacement will offer an esthetic and biocompatible treatment option to patients over the traditional ceramic-metal RBBs. It is anticipated that patient demand for this would be high as these prostheses should be as successful (retentive).

These results would re-write established dental prosthodontics textbooks and this would be the first centre to report on the routine use of a 2-unit extracoronal all-zirconia RBB for the replacement of missing posterior teeth.

Research plan and methodology The sample pool would be obtained from patients presenting at the Prince Philip Dental Hospital, University of Hong Kong and who request and need replacement of one or more missing teeth.. They will be clinically assessed for eligibility and invited to participate with written consent in the study. After treatment they will be reviewed up to a 3rd year endpoint of the study. Further review beyond this will be undertaken.


Condition or disease Intervention/treatment Phase
Missing Teeth Device: Zirconia resin bonded bridge Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Proof of Concept for All-ceramic Zirconia Resin Bonded Bridges for Canine, Premolar and Short Span Posterior Teeth Official Title:
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
Experimental: A proof of concept of using zirconia bonded bridge Device: Zirconia resin bonded bridge



Primary Outcome Measures :
  1. Zirconia bridge clinical retention/survival rate, that is the presence of the zirconia bridge in patients' mouth in review appointment and will be calculated as a percentage of the total bridges placed as well as presented in Kaplan Meier survival curve. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Patient satisfaction in terms of oral health related quality of life (OHrQoL) using Oral Health Impact Profile (OHIP) 49-items questionnaire [ Time Frame: 3 years ]
  2. Patient satisfaction in terms of bridge satisfaction in visual analogue scale (VAS) [ Time Frame: 3 years ]
  3. Complications/adverse outcome associated with Zr bridge reported by patient and detected by clinical assessors [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • The patient is over 18 years old.

    • A minimum of one single missing canine, premolar, or molar tooth raging in length from 6-8 mm as judged by the span between the contact points of the adjacent teeth from study models..
    • After discussion of treatment options, and that RBB is the most suitable treatment option for them, they will be invited to participate in the study.
    • The patient will be rendered dentally fit ie. controlled dental disease - no active caries or periodontal disease
    • Have a minimum of 12 occluding pairs of natural teeth
    • They will have been informed on the nature of the study and signed consent forms agreeing to undertake treatment in the study.
    • Patients will be available to be reviewed at 1, 6, 12, 24, and 36 months and longer.

Exclusion Criteria:

  • • Patients with active tooth decay.

    • Patients with uncontrolled periodontal disease. An RBB abutment with a probing depth greater than 5mm and bleeding on probing.
    • Patients with teeth missing opposite to the planned RBB.
    • Abutment tooth mobility of 2 or greater (Millers classification).
    • Patients with debilitating illnesses or complicating medical conditions.
    • Non-vital or root treated abutment teeth.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793037


Locations
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China, Guangdong
Oral Rehabilitation, Faculty of Dentistry, The University of Hong Kong
Hong Kong, Guangdong, China
Sponsors and Collaborators
The University of Hong Kong

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Responsible Party: Dr Michael G. Botelho, Clinical Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02793037     History of Changes
Other Study ID Numbers: UW 15-205
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

Keywords provided by Dr Michael G. Botelho, The University of Hong Kong:
zirconia
resin bonded bridge

Additional relevant MeSH terms:
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Tooth Loss
Anodontia
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities