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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
Sponsor:
Information provided by:
Queen Mary University of London

Tracking Information
First Submitted Date  ICMJE April 27, 2011
First Posted Date  ICMJE May 4, 2011
Last Update Posted Date February 9, 2012
Study Start Date  ICMJE April 2012
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2011)
Clinical evaluation of adhesive bridges [ Time Frame: 18 months ]
Evaluation of clinical performance: The patients will be evaluated according to the modified USPHS criteria. The evaluation criteria will include: Retention, Framework fracture, Veneering fracture, marginal adaptation, and recurrent caries, Wear and colour match (Appendix I) and the examination will be after 3, 6, 12 and 18 months. Moreover, the marginal adaptation will be assessed by selecting randomly 10 patients. Then, the assessment will be carried out with the use of Co-ordinate measuring machine after 3, 6, 12 and 18 months
Change History Complete list of historical versions of study NCT01347177 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2011)
Quality of life and aesthetic outcome [ Time Frame: 18 months ]
The patients will be requested to fill the OHIP-14 and the VAS questionnaires after 3, 6, 12 and 18 months in order to assess the quality of their lives and their aesthetic outcome after having the bridge. Moreover, three dentists at the same clinic will be asked to fil the VAS dentist questionnaire in order to assess the aesthetic outcome from a professional point of view.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Zirconia and Metal Adhesive Bridges
Official Title  ICMJE A Single-centre Randomised Controlled Clinical Trial of Zirconia-based Versus Metal-based Adhesive Bridges for Replacing 2 Missing Teeth or Less in Adults.
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Missing Teeth
Intervention  ICMJE
  • Procedure: Zirconia-based adhesive bridge
    Zirconia-based adhesive bridge will be used to replace the missing tooth/teeth.
  • Procedure: Metal-based adhesive bridge
    The metal-based adhesive bridge will be used to replace the missing tooth/teeth.
Study Arms
  • 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.
    Intervention: Procedure: Zirconia-based adhesive bridge
  • Experimental: Metal-based adhesive bridges
    Patients in this group will be treated with the employment of metal-based adhesive bridges.
    Intervention: Procedure: Metal-based adhesive bridge
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 12, 2011)
176
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2011)
72
Estimated Study Completion Date April 2018
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01347177
Other Study ID Numbers  ICMJE 100298307
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr Aylin Baysan., Queen Mary University of London.
Study Sponsor  ICMJE Queen Mary University of London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aylin Baysan, BDS, MSc, PhD Queen Mary University of London
Study Director: Amani Agha, BDS,MSc Queen Mary University of London
PRS Account Queen Mary University of London
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP