Missing TeethNCT03029637
No-preparation Resin Bonded Bridges for the Replacement of Single Missing Teeth
A study testing RBBs with no or minimal preparation of their abutment teeth and RBBs with routine tooth preparation of their abutment teeth in people with Missing Teeth, run by The University of Hong Kong at 1 site in China.
Trial summary
Tooth replacement is a significant issue in the World. Such replacement is considered important by patients to improve aesthetics, function and quality of life. Tooth replacement is therefore a significant issue. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- RBBs with no or minimal preparation of their abutment teeth and RBBs with routine tooth preparation of their abutment teeth
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Aug 2021to Dec 2023
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 15+ years old
- A complete bite on the supporting abutment tooth
- At least one missing upper incisor
- Controlled dental disease - no active caries or periodontal diseases
- A minimum of 12 occluding pairs of natural teeth
- Patients will be available to be clinically reviewed up to 3 years
Who cannot join
- Patients with uncontrolled active tooth decay or periodontal disease (i.e. 5+ mm probing depth 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
- Heavily restored tooth abutment not suitable for an RBB
- A supporting abutment with an open bite
Trial locations and contacts
1 site in 1 country.
China1 site
Prosthodontics, Faculty of Dentistry, The University of Hong Kong
Hong Kong
Michael G Botelho, BDS MSc PhD, Botelho@hku.hk
Walter Y. H. Lam, BDS MDS AdvDipProsth, retlaw@hku.hk
About this study
Tooth replacement is a significant issue in the World. Such replacement is considered important by patients to improve aesthetics, function and quality of life. Tooth replacement is therefore a significant issue. Resin-bonded bridges (RBBs) are conservative and cost-effective tooth replacement option that involves minimal tooth preparation and are secured in place with an adhesive cement by bonding to the outer enamel layer of the tooth. Clinical reports of these prostheses at the University of Hong Kong shows some of the highest success rate and greatest longevity in the dental literature. However, a problem with this type of prosthesis in that it still needs some tooth preparation to accommodate the framework thickness of the bridge. In some patients with tooth wear, this may mean cutting through the enamel crown down into dentine which will weaken the tooth. In light of the tooth preparation some patients will refuse this treatment, in particular patients with dental drill phobias.
The aim of this study is to investigate RBBs with tooth preparation and with no tooth preparation for the replacement of single missing teeth in a randomized controlled trial. However, a significant consequence of a no preparation RBB will mean that after cementation the prosthesis will interfere with the patient's bite, making the bridge prosthesis stand high. This will take time for the patient's original occlusion to re-establish itself by the movement of the tooth supporting the bridge. Despite the success of "supra-occluding" restoration has been reported in some studies, currently neither no preparation nor supraoccluding dental bridges are the standard of care for general dental practitioners and have not been reported on as a clinical trial in the literature. Most symptoms reported for supraoccluding restorations were transient and are reversible. The findings of this research will have significant impact on the teaching and practice for clinical prosthodontics and patient care worldwide. Patients will have a dental prosthesis that requires no dental drilling, no local anaesthetic and will have a stronger tooth supporting the bridge that should have greater longevity. More patients, in particular phobic patients will therefore seek treatment for tooth replacement with this conservative treatment option.
- Conditions
- Missing Teeth
- Being tested
- RBBs with no or minimal preparation of their abutment teeth, RBBs with routine tooth preparation of their abutment teeth
- Keywords
- Resin bonded bridges, Randomized controlled trial
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBBs with no or minimal preparation of their abutment teethDevice
Placement of resin bonded bridges on teeth with no or minimal cutting of their supporting teeth
RBBs with routine tooth preparation of their abutment teethDevice
Placement of resin bonded bridges on teeth after routine cutting of their supporting teeth
| Study group | Role | What they receive |
|---|---|---|
| No preparation resin bonded bridges | Experimental | RBBs with no or minimal preparation of their abutment teeth Receives: Device: RBBs with no or minimal preparation of their abutment teeth |
| Routine resin bonded bridges | Active comparator | RBBs with routine tooth preparation of their abutment teeth Receives: Device: RBBs with routine tooth preparation of their abutment teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthesis (resin bonded bridge RBB) retention/survival
Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
Measured: 12 months
Prosthesis (resin bonded bridge RBB) retention/survival
Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
Measured: 24 months
Prosthesis (resin bonded bridge RBB) retention/survival
Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
Measured: 36 months
Secondary outcomes (10)
Adverse events that related to no preparation/supra-occluding treatment approach
Presence of clinical signs and symptoms or not (Yes/No) including but not limited to impact on patient's speech as well as thermal sensitivity, increased tooth mobility, periodontal/pulpal health of the abutment teeth
Measured: Up to 36 months
Time taken to re-establish the occlusion
Settling of occlusion is judged by shimstock/occlusal marking paper on teeth adjacent to the prosthesis
Measured: Up to 36 months
Patient centered outcomes to the Prosthesis (I)
Subject's satisfaction (in visual analogue scale) on the RBB
Measured: 36 months
Patient centered outcomes to the Prosthesis (II)
Impact of RBB on subject's oral health related quality of life (Oral Health Impact Profile, OHIP, in Likert scale)
Measured: 36 months
Patient centered outcomes to the no preparation/supra-occluding treatment approach (I)
Subject's satisfaction (in visual analogue scale) related to the no preparation/supraoccluding treatment approach RBBs
Measured: Up to 12 months
Patient centered outcomes to the no preparation/supra-occluding treatment approach (II)
Impact of the no preparation/supraoccluding treatment approach on subject's oral health related quality of life (Oral Health Impact Profile, OHIP, in Likert scale)
Measured: Up to 12 months
Biomedical mediators of the no preparation/supra-occluding abutment teeth (I)
Prostaglandin E2 level (pg/ul) in the gingival crevicular fluid of abutment teeth
Measured: Up to 36 months
Biomedical mediators of the contralateral control teeth (I)
Prostaglandin E2 level (pg/ul) in the gingival crevicular fluid of contralateral control teeth
Measured: Up to 36 months
Biomedical mediators of the no preparation/supra-occluding abutment teeth (II)
Human Interleukin-1 Family 2 level (pg/ul) in the gingival crevicular fluid of abutment teeth
Measured: Up to 36 months
Biomedical mediators of the contralateral control teeth (II)
Human Interleukin-1 Family 2 level (pg/ul) in the gingival crevicular fluid of contralateral control teeth
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startAug 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
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
- NCT03029637
- Sponsor's protocol ID
- UW 15-205a
- Status last verified
- Aug 2020
- First submitted
- 30 Dec 2016
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- No-preparation Resin Bonded Bridges for the Replacement of Single Missing Teeth
- ClinicalTrials.gov ID
- NCT03029637
- Acronym / sponsor ID
- UW 15-205a
- Conditions
- Missing Teeth
- Keywords
- Resin bonded bridges, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Jan 2017 (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.
Tooth replacement is a significant issue in the World. Such replacement is considered important by patients to improve aesthetics, function and quality of life. Tooth replacement is therefore a significant issue. Resin-bonded bridges (RBBs) are conservative and cost-effective tooth replacement option that involves minimal tooth preparation and are secured in place with an adhesive cement by bonding to the outer enamel layer of the tooth. Clinical reports of these prostheses at the University of Hong Kong shows some of the highest success rate and greatest longevity in the dental literature. However, a problem with this type of prosthesis in that it still needs some tooth preparation to accommodate the framework thickness of the bridge. In some patients with tooth wear, this may mean cutting through the enamel crown down into dentine which will weaken the tooth. In light of the tooth preparation some patients will refuse this treatment, in particular patients with dental drill phobias.
The aim of this study is to investigate RBBs with tooth preparation and with no tooth preparation for the replacement of single missing teeth in a randomized controlled trial. However, a significant consequence of a no preparation RBB will mean that after cementation the prosthesis will interfere with the patient's bite, making the bridge prosthesis stand high. This will take time for the patient's original occlusion to re-establish itself by the movement of the tooth supporting the bridge. Despite the success of "supra-occluding" restoration has been reported in some studies, currently neither no preparation nor supraoccluding dental bridges are the standard of care for general dental practitioners and have not been reported on as a clinical trial in the literature. Most symptoms reported for supraoccluding restorations were transient and are reversible. The findings of this research will have significant impact on the teaching and practice for clinical prosthodontics and patient care worldwide. Patients will have a dental prosthesis that requires no dental drilling, no local anaesthetic and will have a stronger tooth supporting the bridge that should have greater longevity. More patients, in particular phobic patients will therefore seek treatment for tooth replacement with this conservative treatment option.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No preparation resin bonded bridges | Experimental | Device: RBBs with no or minimal preparation of their abutment teethRBBs with no or minimal preparation of their abutment teeth |
| Routine resin bonded bridges | Active comparator | Device: RBBs with routine tooth preparation of their abutment teethRBBs with routine tooth preparation of their abutment teeth |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 15+ years old
- A complete bite on the supporting abutment tooth
- At least one missing upper incisor
- Controlled dental disease - no active caries or periodontal diseases
- A minimum of 12 occluding pairs of natural teeth
Key exclusion criteria (6 listed)
- Patients with uncontrolled active tooth decay or periodontal disease (i.e. 5+ mm probing depth 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
- Heavily restored tooth abutment not suitable for an RBB
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 |
|---|---|---|
| RBBs with no or minimal preparation of their abutment teethPlacement of resin bonded bridges on teeth with no or minimal cutting of their supporting teeth | Device | No preparation resin bonded bridges |
| RBBs with routine tooth preparation of their abutment teethPlacement of resin bonded bridges on teeth after routine cutting of their supporting teeth | Device | Routine resin bonded bridges |
Primary outcome
Prosthesis (resin bonded bridge RBB) retention/survival
Time frame: 12 months
Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
Prosthesis (resin bonded bridge RBB) retention/survival
Time frame: 24 months
Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
Prosthesis (resin bonded bridge RBB) retention/survival
Time frame: 36 months
Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
10 secondary outcomes
Adverse events that related to no preparation/supra-occluding treatment approach
Time frame: Up to 36 months
Time taken to re-establish the occlusion
Time frame: Up to 36 months
Patient centered outcomes to the Prosthesis (I)
Time frame: 36 months
Patient centered outcomes to the Prosthesis (II)
Time frame: 36 months
Patient centered outcomes to the no preparation/supra-occluding treatment approach (I)
Time frame: Up to 12 months
Patient centered outcomes to the no preparation/supra-occluding treatment approach (II)
Time frame: Up to 12 months
Biomedical mediators of the no preparation/supra-occluding abutment teeth (I)
Time frame: Up to 36 months
Biomedical mediators of the contralateral control teeth (I)
Time frame: Up to 36 months
Biomedical mediators of the no preparation/supra-occluding abutment teeth (II)
Time frame: Up to 36 months
Biomedical mediators of the contralateral control teeth (II)
Time frame: Up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RBBs with no or minimal preparation of their abutment teeth and RBBs with routine tooth preparation of their abutment teeth 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 6 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthesis (resin bonded bridge RBB) retention/survival (time frame: 12 months). The study lists 3 primary outcomes in all. 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 18 Aug 2020.