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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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