Clinical Trial of Zirconia and Metal Adhesive Bridges

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2011 by Queen Mary University of London
Sponsor:
Information provided by:
Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01347177
First received: April 27, 2011
Last updated: February 8, 2012
Last verified: January 2011
  Purpose

Adhesive bridges are becoming popular in patients with congenitally missing teeth and these are type of bridges that can be done with only minimal or with no preparation to replace the missing tooth/teeth. The best clinical gain is the minimal tooth preparation or no need for the removal of tooth substance. Treatment for this type of bridges does not usually require anaesthesia. In addition, adhesive bridges can provide reasonable aesthetical outcome with minimal cost and reduced chair time.

The biggest issue is that high failure rate in the long term, and gray colour shining through the metal wing cemented onto the abutment tooth. This can compromise the aesthetical outcome. The aesthetical problem can be solved by the use of zirconia all ceramic material to construct the bridge.


Condition Intervention
Missing Teeth
Procedure: Zirconia-based adhesive bridge
Procedure: Metal-based adhesive bridge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Single-centre Randomised Controlled Clinical Trial of Zirconia-based Versus Metal-based Adhesive Bridges for Replacing 2 Missing Teeth or Less in Adults.

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • Clinical survival of adhesive bridges [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    Evaluation of clinical survival: participants will be evaluated according to the modified USPHS criteria. The evaluation criteria will include: retention, framework fracture, veneering fracture, marginal adaptation, recurrent caries and colour match. The examination will be after one to two weeks, after 3, 6, 9, 12 and 18 months, 2, 3, 4 and 5 years. The evaluation will also include the biological complication. Plaque, gingival index, periodontal probing depth and gingival recession will be evaluated around the abutments and compared to a control tooth


Secondary Outcome Measures:
  • Quality of life, aesthetic outcome. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The patients will be requested to fill the OHIP-14 and the VAS questionnaires after one week to two weeks, after 3, 6, 9, 12 and 18 months in order to assess the quality of their lives and their aesthetic outcome after having the bridge.

  • Marginal discrepancy evaluation. [ Time Frame: After cementation ] [ Designated as safety issue: No ]
    Marginal discrepancy will be evaluated by means of Scannining Electron Microscope (SEM) after cementation.

  • Economic evaluation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Economic evaluation will be run in parallel to the study and will include the overall cost of the two treatments.


Estimated Enrollment: 176
Study Start Date: April 2012
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zirconia-based adhesive bridges
Patients in this group will be treated with the employment of zirconia-based adhesive bridges to replace the missing tooth/teeth.
Procedure: Zirconia-based adhesive bridge
Zirconia-based adhesive bridge will be used to replace the missing tooth/teeth.
Experimental: Metal-based adhesive bridges
Patients in this group will be treated with the employment of metal-based adhesive bridges.
Procedure: Metal-based adhesive bridge
The metal-based adhesive bridge will be used to replace the missing tooth/teeth.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female ≥ 18 years of age
  • Has a maximum of 2 units requiring placement
  • Is a regular dental attendee and agree to return for assessments
  • Written subject informed consent (IC) for this protocol will be obtained prior to study enrolment. Each subject will be required to sign and date the IC form prior to their participation
  • Sound or minimally restored abutment(s)

Exclusion Criteria:

  • The presence of any periodontal pocket depths equal or above 4 mm with active periodontal disease
  • Any history of adverse reaction to clinical materials to be used in this study
  • They are pregnant or had serious medical condition that may interfere with the dental treatment
  • Acquired tooth loss more than 2 units requiring replacement
  • Participants who have parafunctional habits
  • Severe Class II Div II cases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347177

Contacts
Contact: Amani Agha, BDs,MSc amani.agha@qmul.ac.uk

Locations
United Kingdom
Barts and The London, School of Medicine and Dentistry Not yet recruiting
London, United Kingdom, E1 2AD
Contact: Amani Agha       amani.agha@qmul.ac.uk   
Sponsors and Collaborators
Queen Mary University of London
Investigators
Principal Investigator: Aylin Baysan, BDS, MSc, PhD Queen Mary University of London
Study Director: Amani Agha, BDS,MSc Queen Mary University of London
  More Information

No publications provided

Responsible Party: Dr Aylin Baysan., Queen Mary University of London.
ClinicalTrials.gov Identifier: NCT01347177     History of Changes
Other Study ID Numbers: 100298307
Study First Received: April 27, 2011
Last Updated: February 8, 2012
Health Authority: United Kingdom: Queen Mary University of London

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

ClinicalTrials.gov processed this record on July 24, 2014