No-preparation Resin Bonded Bridges for the Replacement of Single Missing Teeth

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
No-preparation Resin Bonded Bridges for the Replacement of Single Missing Teeth

Conditions
-----------------
Missing Teeth

Intervention / Treatment
-----------------
* Device: RBBs with no or minimal preparation of their abutment teeth
* Device: RBBs with routine tooth preparation of their abutment teeth


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No preparation resin bonded bridges<br>RBBs with no or minimal preparation of their abutment teeth | Device: RBBs with no or minimal preparation of their abutment teeth<br>* Placement of resin bonded bridges on teeth with no or minimal cutting of their supporting teeth<br>|
| Active Comparator: Routine resin bonded bridges<br>RBBs with routine tooth preparation of their abutment teeth | Device: RBBs with routine tooth preparation of their abutment teeth<br>* Placement of resin bonded bridges on teeth after routine cutting of their supporting teeth<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prosthesis (resin bonded bridge RBB) retention/survival | Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination | 12 months | 
| Prosthesis (resin bonded bridge RBB) retention/survival | Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination | 24 months | 
| Prosthesis (resin bonded bridge RBB) retention/survival | Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Up to 36 months | 
| Patient centered outcomes to the Prosthesis (I) | Subject's satisfaction (in visual analogue scale) on the RBB | 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) | 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 | 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) | 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 | 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 | 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 | 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 | Up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resin bonded bridges, Randomized controlled trial