Clinical Trial of Zirconia and Metal Adhesive Bridges

NCT01347177 | Withdrawn

• 1 other identifier: 100298307
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Adhesive bridges are becoming popular in patients with congenitally missing teeth and these are type of bridges that can be done with only minimal or with no preparation to replace the missing tooth/teeth. The best clinical gain is the minimal tooth preparation or no need for the removal of tooth substance. Treatment for this type of bridges does not usually require anaesthesia. In addition, adhesive bridges can provide reasonable aesthetical outcome with minimal cost and reduced chair time. The biggest issue is that high failure rate in the long term, and gray colour shining through the metal wing cemented onto the abutment tooth. This can compromise the aesthetical outcome. The aesthetical problem can be solved by the use of zirconia all ceramic material to construct the bridge.

Conditions

Missing Teeth

Outcome Measures

Primary Outcomes (1)

• Clinical survival of adhesive bridges

  Evaluation of clinical survival: participants will be evaluated according to the modified USPHS criteria. The evaluation criteria will include: retention, framework fracture, veneering fracture, marginal adaptation, recurrent caries and colour match. The examination will be after one to two weeks, after 3, 6, 9, 12 and 18 months, 2, 3, 4 and 5 years. The evaluation will also include the biological complication. Plaque, gingival index, periodontal probing depth and gingival recession will be evaluated around the abutments and compared to a control tooth

  5 Years

Secondary Outcomes (3)

• Quality of life, aesthetic outcome.

  18 months

• Marginal discrepancy evaluation.

  After cementation

• Economic evaluation

  5 years

Study Arms (2)

Zirconia-based adhesive bridges

EXPERIMENTAL

Patients in this group will be treated with the employment of zirconia-based adhesive bridges to replace the missing tooth/teeth.

Procedure: Zirconia-based adhesive bridge

Metal-based adhesive bridges

EXPERIMENTAL

Patients in this group will be treated with the employment of metal-based adhesive bridges.

Procedure: Metal-based adhesive bridge

Interventions

Zirconia-based adhesive bridge PROCEDURE

Zirconia-based adhesive bridge will be used to replace the missing tooth/teeth.

Zirconia-based adhesive bridges

Metal-based adhesive bridge PROCEDURE

The metal-based adhesive bridge will be used to replace the missing tooth/teeth.

Metal-based adhesive bridges

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age
• Has a maximum of 2 units requiring placement
• Is a regular dental attendee and agree to return for assessments
• Written subject informed consent (IC) for this protocol will be obtained prior to study enrolment. Each subject will be required to sign and date the IC form prior to their participation
• Sound or minimally restored abutment(s)

You may not qualify if:

• The presence of any periodontal pocket depths equal or above 4 mm with active periodontal disease
• Any history of adverse reaction to clinical materials to be used in this study
• They are pregnant or had serious medical condition that may interfere with the dental treatment
• Acquired tooth loss more than 2 units requiring replacement
• Participants who have parafunctional habits
• Severe Class II Div II cases

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Barts and The London, School of Medicine and Dentistry

London, E1 2AD, United Kingdom

Location

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Aylin Baysan, BDS, MSc, PhD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

• Amani Agha, BDS,MSc

  Queen Mary University of London

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: May 4, 2011
• Study Start: April 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: September 26, 2022

Record last verified: 2011-01

Locations

GB (1)