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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

A randomised clinical trial to determine the aesthetic outcomes of two designs of resin-retained bridge designs

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN33433524
Enrollment
40
Registered
2019-07-22
Start date
2019-08-27
Completion date
Unknown
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental, missing teeth Digestive System Dental, missing teeth

Interventions

Single centre interventional randomised control trial looking to compare the aesthetic outcomes of the current and adjusted design resin-retained bridge after bridge fit. To determine if dentists, pat

Sponsors

University of Bristol
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The aesthetic outcomes of the current and adjusted design resin-retained bridge after bridge fit using the aesthetic assessment questionnaire at least four weeks after bridge fit

Secondary

MeasureTime frame
1. Quality of life measured using OHIP 14 at baseline and at least four weeks after bridge fit 2. Views of dentists, patients with hypodontia and patients attending BDH for other routine treatment about the aesthetics of the two different bridge types measured using GDP aesthetic questionnaires at least four weeks after bridge fit 3. The failure of the adjusted design of resin-retained bridge after 18 months measured by review of patient records.

Countries

United Kingdom

Contacts

Public ContactEmma;Maria MacDonald;Davies

;

e.l.macdonald@bristol.ac.uk;Maria.Davies@bristol.ac.uk+44 (0)117 342 9638;+44 0117 342 9503

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026