Clinical Trial of Zirconia and Metal Adhesive Bridges
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|ClinicalTrials.gov Identifier: NCT01347177|
Recruitment Status : Unknown
Verified January 2011 by Queen Mary University of London.
Recruitment status was: Not yet recruiting
First Posted : May 4, 2011
Last Update Posted : February 9, 2012
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 or disease||Intervention/treatment||Phase|
|Missing Teeth||Procedure: Zirconia-based adhesive bridge Procedure: Metal-based adhesive bridge||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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.|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
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.
- Clinical survival of adhesive bridges [ Time Frame: 5 Years ]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
- Quality of life, aesthetic outcome. [ Time Frame: 18 months ]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 ]Marginal discrepancy will be evaluated by means of Scannining Electron Microscope (SEM) after cementation.
- Economic evaluation [ Time Frame: 5 years ]Economic evaluation will be run in parallel to the study and will include the overall cost of the two treatments.
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): NCT01347177
|Contact: Amani Agha, BDs,MScfirstname.lastname@example.org|
|Barts and The London, School of Medicine and Dentistry|
|London, United Kingdom, E1 2AD|
|Contact: Amani Agha email@example.com|
|Principal Investigator:||Aylin Baysan, BDS, MSc, PhD||Queen Mary University of London|
|Study Director:||Amani Agha, BDS,MSc||Queen Mary University of London|