Missing TeethNCT02793037
A Proof of Concept for All-ceramic Zirconia Resin Bonded Bridges for Canine, Premolar and Short Span Posterior Teeth
A study testing Zirconia resin bonded bridge in people with Missing Teeth, run by The University of Hong Kong at 1 site in China.
Trial summary
Trial Design - Objectives and Purpose The aim of this study is to perform a proof of concept for the successful retention and outcome measures of zirconia RBBs for the replacement of missing canine or posterior teeth (6-8mm span) and that they will exhibit similar survival rates (95%) as metal ceramic RBBs over 3… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- Zirconia resin bonded bridge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jun 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • The patient is over 18 years old.
- A minimum of one single missing canine, premolar, or molar tooth raging in length from 6-8 mm as judged by the span between the contact points of the adjacent teeth from study models..
- After discussion of treatment options, and that RBB is the most suitable treatment option for them, they will be invited to participate in the study.
- The patient will be rendered dentally fit ie. controlled dental disease - no active caries or periodontal disease
- Have a minimum of 12 occluding pairs of natural teeth
- They will have been informed on the nature of the study and signed consent forms agreeing to undertake treatment in the study.
- Patients will be available to be reviewed at 1, 6, 12, 24, and 36 months and longer.
Who cannot join
- • Patients with active tooth decay.
- Patients with uncontrolled periodontal disease. An RBB abutment with a probing depth greater than 5mm and bleeding on probing.
- Patients with teeth missing opposite to the planned RBB.
- Abutment tooth mobility of 2 or greater (Millers classification).
- Patients with debilitating illnesses or complicating medical conditions.
- Non-vital or root treated abutment teeth.
Trial locations and contacts
1 site in 1 country.
China1 site
Oral Rehabilitation, Faculty of Dentistry, The University of Hong Kong
Hong Kong, Guangdong
About this study
Official title: A Proof of Concept for All-ceramic Zirconia Resin Bonded Bridges for Canine, Premolar and Short Span Posterior Teeth Official Title:
Trial Design - Objectives and Purpose The aim of this study is to perform a proof of concept for the successful retention and outcome measures of zirconia RBBs for the replacement of missing canine or posterior teeth (6-8mm span) and that they will exhibit similar survival rates (95%) as metal ceramic RBBs over 3 years and short term (Botelho 2006).
The use of monolithic extra-coronal zirconia RBBs in the posterior region does not appear to have been reported in the literature (A search pf Pub Med and Google Scholar has not shown any similar studies that have been published - pubmed.gov; Keywords: "zirconia", "resin", "clinical" assessed on 17/10/2015 AND google scholar; Keywords: "zirconia", "resin bonded fixed partial denture", "resin bonded fixed dental prosthesis", "Maryland", "resin bonded bridge" "posterior", "clinical") In addition, currently there appear to be no clinical trials planned or finished in this area (clinicaltrial.gov; Keywords: "zirconia", "resin" assessed on 17/10/2015) using zirconia RBBs in the posterior region. This reveals that there is a gap in the literature on the use of zirconia for replacing posterior teeth with such prostheses.
Read more
The primary outcome measures would be: success ie. prosthesis retention ie. does not fall out
The secondary outcome measures would be:
- complications of the prosthesis such as tipping, drifting or fracture.
- patient centered outcomes (satisfaction and oral health related quality of life) on the RBBs The hypothesis is that 2-unit cantilevered zirconia RBBs will be as successful as current data on 2-unit cantilevered metal-ceramic RBBs from this centre and that there will be no difference in the patient centered outcomes.
The Primary review appointments will be at 1, 6, 12, 24 and 36 months. However, longer term follow up will be performed and this centre has experience of such long term studies (9.5 years - Botelho 2014).
A randomized clinical trial (RCT) comparing to metal-ceramic RBBs will NOT be performed as the 5-year success rate of both metal-ceramic (Botelho 2006) and anterior zirconia (Sasse 2014) prosthesis were higher than 95% and this small differences would mean an unattainable large sample size in an equivalence test (Burns 2001).
Significance and implications Zirconia has significant strength and greater stiffness than base metal alloys and displays clinical outcomes comparable to metal-ceramic conventional crowns and bridges (Heintze 2010, Sailer 2007). Well polished zirconia has been observed to have lower wear rates than porcelain (Stober 2014) Zirconia RBBs for posterior tooth replacement will offer an esthetic and biocompatible treatment option to patients over the traditional ceramic-metal RBBs. It is anticipated that patient demand for this would be high as these prostheses should be as successful (retentive).
These results would re-write established dental prosthodontics textbooks and this would be the first centre to report on the routine use of a 2-unit extracoronal all-zirconia RBB for the replacement of missing posterior teeth.
Research plan and methodology The sample pool would be obtained from patients presenting at the Prince Philip Dental Hospital, University of Hong Kong and who request and need replacement of one or more missing teeth.. They will be clinically assessed for eligibility and invited to participate with written consent in the study. After treatment they will be reviewed up to a 3rd year endpoint of the study. Further review beyond this will be undertaken.
- Conditions
- Missing Teeth
- Being tested
- Zirconia resin bonded bridge
- Keywords
- zirconia, resin bonded 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 resin bonded bridgeDevice
| Study group | Role | What they receive |
|---|---|---|
| A proof of concept of using zirconia bonded bridge | Experimental | Not described Receives: Device: Zirconia resin bonded bridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zirconia bridge clinical retention/survival rate, that is the presence of the zirconia bridge in patients' mouth in review appointment and will be calculated as a percentage of the total bridges placed as well as presented in Kaplan Meier survival curve.
Measured: 3 years
Secondary outcomes (3)
Patient satisfaction in terms of oral health related quality of life (OHrQoL) using Oral Health Impact Profile (OHIP) 49-items questionnaire
Measured: 3 years
Patient satisfaction in terms of bridge satisfaction in visual analogue scale (VAS)
Measured: 3 years
Complications/adverse outcome associated with Zr bridge reported by patient and detected by clinical assessors
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Missing TeethStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Michael G. Botelho, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793037
- Sponsor's protocol ID
- UW 15-205
- Status last verified
- Aug 2020
- First submitted
- 20 May 2016
- Last updated
- 18 Aug 2020
- Results posted
- No
Publications
Lam WYH, Lim TW, Yu Yon MJ, Chau JMH, Lai GCH, Wang DCP, Botelho MG. Posterior two-unit cantilevered zirconia resin-bonded fixed partial dentures: A 3-year prospective single-arm clinical trial. J Dent. 2024 Aug;147:105140. doi: 10.1016/j.jdent.2024.105140. Epub 2024 Jun 18.
PubMed 38901823
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept for All-ceramic Zirconia Resin Bonded Bridges for Canine, Premolar and Short Span Posterior Teeth Official Title:
- ClinicalTrials.gov ID
- NCT02793037
- Acronym / sponsor ID
- UW 15-205
- Conditions
- Missing Teeth
- Keywords
- zirconia, resin bonded bridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 8 Jun 2016 (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.
Trial Design - Objectives and Purpose The aim of this study is to perform a proof of concept for the successful retention and outcome measures of zirconia RBBs for the replacement of missing canine or posterior teeth (6-8mm span) and that they will exhibit similar survival rates (95%) as metal ceramic RBBs over 3 years and short term (Botelho 2006).
The use of monolithic extra-coronal zirconia RBBs in the posterior region does not appear to have been reported in the literature (A search pf Pub Med and Google Scholar has not shown any similar studies that have been published - pubmed.gov; Keywords: "zirconia", "resin", "clinical" assessed on 17/10/2015 AND google scholar; Keywords: "zirconia", "resin bonded fixed partial denture", "resin bonded fixed dental prosthesis", "Maryland", "resin bonded bridge" "posterior", "clinical") In addition, currently there appear to be no clinical trials planned or finished in this area (clinicaltrial.gov; Keywords: "zirconia", "resin" assessed on 17/10/2015) using zirconia RBBs in the posterior region. This reveals that there is a gap in the literature on the use of zirconia for replacing posterior teeth with such prostheses.
The primary outcome measures would be: success ie. prosthesis retention ie. does not fall out
The secondary outcome measures would be:
- complications of the prosthesis such as tipping, drifting or fracture.
- patient centered outcomes (satisfaction and oral health related quality of life) on the RBBs The hypothesis is that 2-unit cantilevered zirconia RBBs will be as successful as current data on 2-unit cantilevered metal-ceramic RBBs from this centre and that there will be no difference in the patient centered outcomes.
The Primary review appointments will be at 1, 6, 12, 24 and 36 months. However, longer term follow up will be performed and this centre has experience of such long term studies (9.5 years - Botelho 2014).
A randomized clinical trial (RCT) comparing to metal-ceramic RBBs will NOT be performed as the 5-year success rate of both metal-ceramic (Botelho 2006) and anterior zirconia (Sasse 2014) prosthesis were higher than 95% and this small differences would mean an unattainable large sample size in an equivalence test (Burns 2001).
Significance and implications Zirconia has significant strength and greater stiffness than base metal alloys and displays clinical outcomes comparable to metal-ceramic conventional crowns and bridges (Heintze 2010, Sailer 2007). Well polished zirconia has been observed to have lower wear rates than porcelain (Stober 2014) Zirconia RBBs for posterior tooth replacement will offer an esthetic and biocompatible treatment option to patients over the traditional ceramic-metal RBBs. It is anticipated that patient demand for this would be high as these prostheses should be as successful (retentive).
These results would re-write established dental prosthodontics textbooks and this would be the first centre to report on the routine use of a 2-unit extracoronal all-zirconia RBB for the replacement of missing posterior teeth.
Research plan and methodology The sample pool would be obtained from patients presenting at the Prince Philip Dental Hospital, University of Hong Kong and who request and need replacement of one or more missing teeth.. They will be clinically assessed for eligibility and invited to participate with written consent in the study. After treatment they will be reviewed up to a 3rd year endpoint of the study. Further review beyond this will be undertaken.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A proof of concept of using zirconia bonded bridge | Experimental | Device: Zirconia resin bonded bridge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • The patient is over 18 years old.
Key exclusion criteria (6 listed)
- • Patients with active tooth decay.
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 resin bonded bridge | Device | A proof of concept of using zirconia bonded bridge |
Primary outcome
Zirconia bridge clinical retention/survival rate, that is the presence of the zirconia bridge in patients' mouth in review appointment and will be calculated as a percentage of the total bridges placed as well as presented in Kaplan Meier survival curve.
Time frame: 3 years
3 secondary outcomes
Patient satisfaction in terms of oral health related quality of life (OHrQoL) using Oral Health Impact Profile (OHIP) 49-items questionnaire
Time frame: 3 years
Patient satisfaction in terms of bridge satisfaction in visual analogue scale (VAS)
Time frame: 3 years
Complications/adverse outcome associated with Zr bridge reported by patient and detected by clinical assessors
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Derived from this study: PubMed 38901823Lam WYH, Lim TW, Yu Yon MJ, Chau JMH, Lai GCH, Wang DCP, Botelho MG. Posterior two-unit cantilevered zirconia resin-bonded fixed partial dentures: A 3-year prospective single-arm clinical trial. J Dent. 2024 Aug;147:105140. doi: 10.1016/j.jdent.2024.105140. Epub 2024 Jun 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 resin bonded bridge in people with Missing Teeth, run by The University of Hong Kong at 1 site in China.
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 7 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: finished, as of the sponsor's last update on 18 Aug 2020. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Zirconia bridge clinical retention/survival rate, that is the presence of the zirconia bridge in patients' mouth in review appointment and will be calculated as a percentage of the total bridges placed as well as presented in Kaplan Meier survival curve. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02793037, which also lists 1 linked publication.
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 18 Aug 2020.