A randomised control clinical trial of two dental bridges replacing teeth, comparing the two designs, looking at the aesthetics and failure rate of these designs

Not Applicable

Suspended

• Conditions: Dental, missing teeth; Digestive System

• Registration Number: ISRCTN33433524
• Lead Sponsor: niversity of Bristol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-22
• Last Update Posted: 12 April 2021
• Study Completion: 2021-12-04

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
2. Compliance: Understands and is willing, able and likely to comply with all study procedures
3. General Health: Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history on oral examination
4. Oral Cavity, participants must:
4.1 Have at least one missing tooth, bounded by teeth, which is a single unit in the front of the mouth, being either an incisor or canine (UR123 UL123 LR123 LL123).
4.2 Have teeth that can be used as abutments (for attachment of the RRB) that are unrestored and without pathology
4.3 Be able to accommodate a pontic tooth replacement restoration
4.4 Have no more than mild tooth wear with Basic Erosive Wear Examination (BEWE) score of 1 or less (Bartlett et al 2008) with no history of parafunctional habits
5. Have good oral hygiene with:
5.1 Full mouth Turesky plaque index score <1 (Turesky et al 1970)
5.2 Basic Periodontal Exam (BPE) scores of 0, 1, 2. With a maximum of one sextant with a score of 3.
6. Aged 11 years or older

Exclusion Criteria

1. Current or recurrent disease/dental pathology that could affect bridge treatment
2. Bleeding disorders
3. Immuno-compromised.
4. Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, or any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the study products or procedures
5. Known or suspected intolerance or sensitivity to the study materials (or closely related compounds) or any of their stated ingredients
6. Any medication which in the investigators opinion may interfere with the study
7. Participation in another clinical study or receipt of an investigational drug within 10 days of the screening visit
8. Recent history of alcohol or other substance abuse
9. Any patient who, in the judgement of the investigator, should not participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified