Survival of Root Canal Treated Teeth Restored With Ceramic Onlays

NCT03378778 | Completed

• 1 other identifier: IRAS Project ID: 224248
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Advances in digital dentistry coupled with increased demand for aesthetic restorations have led to developments in CAD CAM( Computer Aided Design and Computer Aided manufacturing)systems for manufacturing tooth restorations. CAD CAM restorations have the added benefit of digital impressions which eliminate the need to take conventional impressions, something patients find difficult to tolerate. CAD CAM restorations are now part of routine dental care. However there are no clinical studies evaluating these restorations on root canal treated teeth This study aims to compare the success and survival of root canal treated teeth and/or restoration with varying degrees of tooth structure loss restored using CAD CAM restorations. Null Hypothesis:- The amount of residual coronal dentin has no effect on the survival of root canal treated teeth and/or restoration.

Conditions

Dental Pulp Diseases

Outcome Measures

Primary Outcomes (2)

• Success of root canal treatment

  Outcome of root canal treatment assessed using CBCT

  Upto 24 months

• Survival of Ceramic Onlays

  Survival of ceramic onlays assessed using modified USPHS criteria

  Upto 24 months

Secondary Outcomes (1)

• Main types of failure of restoration.

  Upto 24 months

Study Arms (4)

Less than 33% Tooth Structure remaining

Root canal treatment followed by CAD CAM restoration

Procedure: Root canal treatment

33%-50% tooth structure remaining

Root canal treatment followed by CAD CAM restoration

Procedure: Root canal treatment

50% -66% tooth structure remaining

Root canal treatment followed by CAD CAM restoration

Procedure: Root canal treatment

More than 66% tooth structure remaining

Root canal treatment followed by CAD CAM restoration

Procedure: Root canal treatment

Interventions

Root canal treatment PROCEDURE

Root Canal Treatment followed by Ceramic Onlay restoration

33%-50% tooth structure remaining; 50% -66% tooth structure remaining; Less than 33% Tooth Structure remaining; More than 66% tooth structure remaining

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Routine patients requiring root canal treatment at Guy's Hospital, London

You may qualify if:

• Patients either male or female over the age of 18 (who can consent for themselves) in good general health.
• The selected teeth needed to be in occlusal function with a natural tooth and in interproximal contact with two adjacent natural teeth.
• Molar or premolar teeth with suspected endodontic problems that require root canal treatment.
• Teeth should not be mobile and must be restorable.

You may not qualify if:

• Pregnant women, in view of requirements for radiographs (or if they could possibly be pregnant). To be confirmed by the Medical History Questionnaire.
• Patients younger than 18.
• Patients unable to give consent.
• Teeth with probing periodontal depths greater than 5 mm.
• Non-restorable teeth.
• Not involving patients from prisons.
• Not involving patients who cannot read, write or understand English

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Guy's Hospital

London, SE19RT, United Kingdom

Location

Related Publications (2)

• Al-Nuaimi N, Patel S, Austin RS, Mannocci F. A prospective study assessing the effect of coronal tooth structure loss on the outcome of root canal retreatment. Int Endod J. 2017 Dec;50(12):1143-1157. doi: 10.1111/iej.12760. Epub 2017 Apr 9.

  PMID: 28294354 BACKGROUND

• Beier US, Kapferer I, Burtscher D, Giesinger JM, Dumfahrt H. Clinical performance of all-ceramic inlay and onlay restorations in posterior teeth. Int J Prosthodont. 2012 Jul-Aug;25(4):395-402.

  PMID: 22720292 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Francesco Mannocci

  Professor of Endodontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Endodontology

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 20, 2017
• Study Start: January 1, 2018
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: December 3, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement

Locations

GB (1)