Missing TeethNCT01347177
Clinical Trial of Zirconia and Metal Adhesive Bridges
A study testing Zirconia-based adhesive bridge and Metal-based adhesive bridge in people with Missing Teeth, run by Queen Mary University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- Zirconia-based adhesive bridge and Metal-based adhesive bridge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Barts and The London, School of Medicine and Dentistry
London, E1 2AD
About this study
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.
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.
- Conditions
- Missing Teeth
- Being tested
- Zirconia-based adhesive bridge, Metal-based adhesive bridge
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia-based adhesive bridgeProcedure or surgery
Zirconia-based adhesive bridge will be used to replace the missing tooth/teeth.
Metal-based adhesive bridgeProcedure or surgery
The metal-based adhesive bridge will be used to replace the missing tooth/teeth.
| Study group | Role | What they receive |
|---|---|---|
| Zirconia-based adhesive bridges | Experimental | Patients in this group will be treated with the employment of zirconia-based adhesive bridges to replace the missing tooth/teeth. Receives: Procedure: Zirconia-based adhesive bridge |
| Metal-based adhesive bridges | Experimental | Patients in this group will be treated with the employment of metal-based adhesive bridges. Receives: Procedure: Metal-based adhesive bridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 Years
Secondary outcomes (3)
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.
Measured: 18 months
Marginal discrepancy evaluation.
Marginal discrepancy will be evaluated by means of Scannining Electron Microscope (SEM) after cementation.
Measured: After cementation
Economic evaluation
Economic evaluation will be run in parallel to the study and will include the overall cost of the two treatments.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startApr 2012
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing TeethStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aylin Baysan, BDS, MSc, PhD, Principal investigator, Queen Mary University of LondonAmani Agha, BDS,MSc, Study director, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347177
- Sponsor's protocol ID
- 100298307
- Status last verified
- Jan 2011
- First submitted
- 27 Apr 2011
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01347177
- Acronym / sponsor ID
- 100298307
- Conditions
- Missing Teeth
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 4 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zirconia-based adhesive bridges | Experimental | Procedure: Zirconia-based adhesive bridgePatients in this group will be treated with the employment of zirconia-based adhesive bridges to replace the missing tooth/teeth. |
| Metal-based adhesive bridges | Experimental | Procedure: Metal-based adhesive bridgePatients in this group will be treated with the employment of metal-based adhesive bridges. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zirconia-based adhesive bridgeZirconia-based adhesive bridge will be used to replace the missing tooth/teeth. | Procedure or surgery | Zirconia-based adhesive bridges |
| Metal-based adhesive bridgeThe metal-based adhesive bridge will be used to replace the missing tooth/teeth. | Procedure or surgery | Metal-based adhesive bridges |
Primary outcome
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
3 secondary outcomes
Quality of life, aesthetic outcome.
Time frame: 18 months
Marginal discrepancy evaluation.
Time frame: After cementation
Economic evaluation
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aylin Baysan, BDS, MSc, PhD principal investigator
Queen Mary University of London
Amani Agha, BDS,MSc study director
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zirconia-based adhesive bridge and Metal-based adhesive bridge in people with Missing Teeth, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical survival of adhesive bridges (time frame: 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.