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

Missing Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03029637
• Other study ID #: UW 15-205a
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: December 2023

Study information

• Verified date: August 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anodontia
• Missing Teeth
• Tooth Loss

Intervention

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
• RBBs with routine tooth preparation of their abutment teeth
Placement of resin bonded bridges on teeth after routine cutting of their supporting teeth

Locations

Country	Name	City	State
China	Prosthodontics, Faculty of Dentistry, The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prosthesis (resin bonded bridge RBB) retention/survival	Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination	12 months
Primary	Prosthesis (resin bonded bridge RBB) retention/survival	Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination	24 months
Primary	Prosthesis (resin bonded bridge RBB) retention/survival	Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination	36 months
Secondary	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
Secondary	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
Secondary	Patient centered outcomes to the Prosthesis (I)	Subject's satisfaction (in visual analogue scale) on the RBB	36 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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