No-preparation Resin Bonded Bridges for the Replacement of Single Missing Teeth
Primary Purpose
Missing Teeth
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RBBs with no or minimal preparation of their abutment teeth
RBBs with routine tooth preparation of their abutment teeth
Sponsored by
About this trial
This is an interventional treatment trial for Missing Teeth focused on measuring Resin bonded bridges, Randomized controlled trial
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
Sites / Locations
- Prosthodontics, Faculty of Dentistry, The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
No preparation resin bonded bridges
Routine resin bonded bridges
Arm Description
RBBs with no or minimal preparation of their abutment teeth
RBBs with routine tooth preparation of their abutment teeth
Outcomes
Primary Outcome Measures
Prosthesis (resin bonded bridge RBB) retention/survival
Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
Prosthesis (resin bonded bridge RBB) retention/survival
Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
Prosthesis (resin bonded bridge RBB) retention/survival
Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
Secondary Outcome Measures
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
Time taken to re-establish the occlusion
Settling of occlusion is judged by shimstock/occlusal marking paper on teeth adjacent to the prosthesis
Patient centered outcomes to the Prosthesis (I)
Subject's satisfaction (in visual analogue scale) on the RBB
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)
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
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)
Biomedical mediators of the no preparation/supra-occluding abutment teeth (I)
Prostaglandin E2 level (pg/ul) in the gingival crevicular fluid of abutment teeth
Biomedical mediators of the contralateral control teeth (I)
Prostaglandin E2 level (pg/ul) in the gingival crevicular fluid of contralateral control teeth
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
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
Full Information
NCT ID
NCT03029637
First Posted
December 30, 2016
Last Updated
August 16, 2020
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03029637
Brief Title
No-preparation Resin Bonded Bridges for the Replacement of Single Missing Teeth
Official Title
No-preparation Resin Bonded Bridges for the Replacement of Single Missing Teeth
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth
Keywords
Resin bonded bridges, Randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No preparation resin bonded bridges
Arm Type
Experimental
Arm Description
RBBs with no or minimal preparation of their abutment teeth
Arm Title
Routine resin bonded bridges
Arm Type
Active Comparator
Arm Description
RBBs with routine tooth preparation of their abutment teeth
Intervention Type
Device
Intervention Name(s)
RBBs with no or minimal preparation of their abutment teeth
Intervention Description
Placement of resin bonded bridges on teeth with no or minimal cutting of their supporting teeth
Intervention Type
Device
Intervention Name(s)
RBBs with routine tooth preparation of their abutment teeth
Intervention Description
Placement of resin bonded bridges on teeth after routine cutting of their supporting teeth
Primary Outcome Measure Information:
Title
Prosthesis (resin bonded bridge RBB) retention/survival
Description
Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
Time Frame
12 months
Title
Prosthesis (resin bonded bridge RBB) retention/survival
Description
Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
Time Frame
24 months
Title
Prosthesis (resin bonded bridge RBB) retention/survival
Description
Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Adverse events that related to no preparation/supra-occluding treatment approach
Description
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
Time Frame
Up to 36 months
Title
Time taken to re-establish the occlusion
Description
Settling of occlusion is judged by shimstock/occlusal marking paper on teeth adjacent to the prosthesis
Time Frame
Up to 36 months
Title
Patient centered outcomes to the Prosthesis (I)
Description
Subject's satisfaction (in visual analogue scale) on the RBB
Time Frame
36 months
Title
Patient centered outcomes to the Prosthesis (II)
Description
Impact of RBB on subject's oral health related quality of life (Oral Health Impact Profile, OHIP, in Likert scale)
Time Frame
36 months
Title
Patient centered outcomes to the no preparation/supra-occluding treatment approach (I)
Description
Subject's satisfaction (in visual analogue scale) related to the no preparation/supraoccluding treatment approach RBBs
Time Frame
Up to 12 months
Title
Patient centered outcomes to the no preparation/supra-occluding treatment approach (II)
Description
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)
Time Frame
Up to 12 months
Title
Biomedical mediators of the no preparation/supra-occluding abutment teeth (I)
Description
Prostaglandin E2 level (pg/ul) in the gingival crevicular fluid of abutment teeth
Time Frame
Up to 36 months
Title
Biomedical mediators of the contralateral control teeth (I)
Description
Prostaglandin E2 level (pg/ul) in the gingival crevicular fluid of contralateral control teeth
Time Frame
Up to 36 months
Title
Biomedical mediators of the no preparation/supra-occluding abutment teeth (II)
Description
Human Interleukin-1 Family 2 level (pg/ul) in the gingival crevicular fluid of abutment teeth
Time Frame
Up to 36 months
Title
Biomedical mediators of the contralateral control teeth (II)
Description
Human Interleukin-1 Family 2 level (pg/ul) in the gingival crevicular fluid of contralateral control teeth
Time Frame
Up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Prosthodontics, Faculty of Dentistry, The University of Hong Kong
City
Hong Kong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael G Botelho, BDS MSc PhD
Email
Botelho@hku.hk
First Name & Middle Initial & Last Name & Degree
Walter Y. H. Lam, BDS MDS AdvDipProsth
Email
retlaw@hku.hk
First Name & Middle Initial & Last Name & Degree
Michael G Botelho, BDS MSc PhD
First Name & Middle Initial & Last Name & Degree
Walter Y. H. Lam, BDS MDS AdvDipProsth
First Name & Middle Initial & Last Name & Degree
Edward C. M. Lo, BDS MDS PhD
First Name & Middle Initial & Last Name & Degree
Henry W. K. Luk, PhD
First Name & Middle Initial & Last Name & Degree
Yanqi Yang, BDS, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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No-preparation Resin Bonded Bridges for the Replacement of Single Missing Teeth
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