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

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 Overview

• Status: Not yet recruiting
• 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

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Prosthodontics, Faculty of Dentistry, The University of Hong Kong
    • Contact: Michael G Botelho, BDS MSc PhD; Email: Botelho@hku.hk
    • Contact: Walter Y. H. Lam, BDS MDS AdvDipProsth; Email: retlaw@hku.hk
    • Principal Investigator: Michael G Botelho, BDS MSc PhD
    • Sub-Investigator: Walter Y. H. Lam, BDS MDS AdvDipProsth
    • Sub-Investigator: Edward C. M. Lo, BDS MDS PhD
    • Sub-Investigator: Henry W. K. Luk, PhD
    • Sub-Investigator: Yanqi Yang, BDS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 15+ years old
2. A complete bite on the supporting abutment tooth
3. At least one missing upper incisor
4. Controlled dental disease - no active caries or periodontal diseases
5. A minimum of 12 occluding pairs of natural teeth
6. Patients will be available to be clinically reviewed up to 3 years

Exclusion Criteria:

1. Patients with uncontrolled active tooth decay or periodontal disease (i.e. 5+ mm probing depth and bleeding on probing).
2. Patients with teeth missing opposite to the planned RBB
3. Abutment tooth mobility of 2 or greater (Millers classification)
4. Patients with debilitating illnesses or complicating medical conditions
5. Heavily restored tooth abutment not suitable for an RBB
6. A supporting abutment with an open bite

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 30, 2016
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimate): January 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 16, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Resin bonded bridges
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Tooth Loss; Anodontia
• Other Study ID Numbers: UW 15-205a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No