Clinical Trial of Zirconia and Metal Adhesive Bridges

Missing Teeth Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01347177
• Other study ID #: 100298307
• Status: Withdrawn
• Phase: N/A
• Start date: April 2012
• Est. completion date: April 2018

Study information

• Verified date: January 2011
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anodontia
• Missing Teeth
• Tooth Loss

Intervention

Procedure:
• Zirconia-based adhesive bridge
Zirconia-based adhesive bridge will be used to replace the missing tooth/teeth.
• Metal-based adhesive bridge
The metal-based adhesive bridge will be used to replace the missing tooth/teeth.

Locations

Country	Name	City	State
United Kingdom	Barts and The London, School of Medicine and Dentistry	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical survival of adhesive bridges	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	5 Years
Secondary	Quality of life, aesthetic outcome.	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.	18 months
Secondary	Marginal discrepancy evaluation.	Marginal discrepancy will be evaluated by means of Scannining Electron Microscope (SEM) after cementation.	After cementation
Secondary	Economic evaluation	Economic evaluation will be run in parallel to the study and will include the overall cost of the two treatments.	5 years