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Clinical Trial of Zirconia and Metal Adhesive Bridges

Primary Purpose

Missing Teeth

Status

Withdrawn

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Zirconia-based adhesive bridge

Metal-based adhesive bridge

About this trial

This is an interventional other trial for Missing Teeth

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Barts and The London, School of Medicine and Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Zirconia-based adhesive bridges

Metal-based adhesive bridges

Arm Description

Patients in this group will be treated with the employment of zirconia-based adhesive bridges to replace the missing tooth/teeth.

Patients in this group will be treated with the employment of metal-based adhesive bridges.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Marginal discrepancy evaluation.

Marginal discrepancy will be evaluated by means of Scannining Electron Microscope (SEM) after cementation.

Economic evaluation

Economic evaluation will be run in parallel to the study and will include the overall cost of the two treatments.

Full Information

NCT ID

NCT01347177

First Posted

April 27, 2011

Last Updated

September 23, 2022

Sponsor

Queen Mary University of London

1. Study Identification

Unique Protocol Identification Number

NCT01347177

Brief Title

Clinical Trial of Zirconia and Metal Adhesive Bridges

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 Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Withdrawn

Study Start Date

April 2012 (undefined)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Queen Mary University of London

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Missing Teeth

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zirconia-based adhesive bridges

Arm Type

Experimental

Arm Description

Patients in this group will be treated with the employment of zirconia-based adhesive bridges to replace the missing tooth/teeth.

Arm Title

Metal-based adhesive bridges

Arm Type

Experimental

Arm Description

Patients in this group will be treated with the employment of metal-based adhesive bridges.

Intervention Type

Procedure

Intervention Name(s)

Zirconia-based adhesive bridge

Intervention Description

Zirconia-based adhesive bridge will be used to replace the missing tooth/teeth.

Intervention Type

Procedure

Intervention Name(s)

Metal-based adhesive bridge

Intervention Description

The metal-based adhesive bridge will be used to replace the missing tooth/teeth.

Primary Outcome Measure Information:

Title

Clinical survival of adhesive bridges

Description

Time Frame

5 Years

Secondary Outcome Measure Information:

Title

Quality of life, aesthetic outcome.

Description

Time Frame

18 months

Title

Marginal discrepancy evaluation.

Description

Marginal discrepancy will be evaluated by means of Scannining Electron Microscope (SEM) after cementation.

Time Frame

After cementation

Title

Economic evaluation

Description

Economic evaluation will be run in parallel to the study and will include the overall cost of the two treatments.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aylin Baysan, BDS, MSc, PhD

Organizational Affiliation

Queen Mary University of London

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Amani Agha, BDS,MSc

Organizational Affiliation

Queen Mary University of London

Official's Role

Study Director

Facility Information:

Facility Name

Barts and The London, School of Medicine and Dentistry

City

London

ZIP/Postal Code

E1 2AD

Country

United Kingdom

12. IPD Sharing Statement

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Clinical Trial of Zirconia and Metal Adhesive Bridges

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