Survival of Root Canal Treated Teeth Restored With Ceramic Onlays

December 2, 2020 updated by: Professor Francesco Mannocci, King's College London

The Success and Survival of Teeth and Restoration Following Root Canal Treatment With Varying Degrees of Tooth Structure Loss Restored With CAD CAM Restorations.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be carried out at KCL Dental Institute at Guy's Hospital and will form part of the routine dental treatment done at the endodontic postgraduate unit. Potential volunteers will be given written information about the process and be given time to consider participation. Once any questions have been answered, fully informed written consent will be obtained if they are interested in taking part. Patients requiring endodontic treatment with varying degrees of tooth structure loss will be detected, diagnosed and treated by endodontic MClinDent postgraduate students at Guy's hospital using suitable clinical techniques. The teeth will then be restored using CAD CAM restorations. Dental periapical radiograph and cone beam computed tomography (CBCT)scans (Morita Accuitomo) will be taken at baseline, 12 months and 24 months. Clinical assessment and radiographical evaluation will be carried out immediately after endodontic treatments have been accomplished and 1 and 2 years post treatment and will be assessed independently by a group of examiners. It is hoped that data analysed from this study will provide a definitive clinical evidence base for the success and survival of endodontically teeth and/or restorations.

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Less than 33% Tooth Structure remaining
Root canal treatment followed by CAD CAM restoration
Procedure: Root canal treatment
Root Canal Treatment followed by Ceramic Onlay restoration
33%-50% tooth structure remaining
Root canal treatment followed by CAD CAM restoration
Procedure: Root canal treatment
Root Canal Treatment followed by Ceramic Onlay restoration
50% -66% tooth structure remaining
Root canal treatment followed by CAD CAM restoration
Procedure: Root canal treatment
Root Canal Treatment followed by Ceramic Onlay restoration
More than 66% tooth structure remaining
Root canal treatment followed by CAD CAM restoration
Procedure: Root canal treatment
Root Canal Treatment followed by Ceramic Onlay restoration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of root canal treatment
Time Frame: Upto 24 months
Outcome of root canal treatment assessed using CBCT
Upto 24 months
Survival of Ceramic Onlays
Time Frame: Upto 24 months
Survival of ceramic onlays assessed using modified USPHS criteria
Upto 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main types of failure of restoration.
Time Frame: Upto 24 months
Modified USPHS criteria will be used to identify the main types of failure of these restorations.
Upto 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Investigators

  • Principal Investigator: Francesco Mannocci, Professor of Endodontology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

December 5, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 20, 2017

Study Record Updates

Last Update Posted (Actual)

December 3, 2020

Last Update Submitted That Met QC Criteria

December 2, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS Project ID: 224248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual data for all primary and secondary outcome measurements will be made available

IPD Sharing Time Frame

Data will be available within 6 months of study completion

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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