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Survival of Root Canal Treated Teeth Restored With Ceramic Onlays

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03378778
Recruitment Status : Completed
First Posted : December 20, 2017
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
Professor Francesco Mannocci, King's College London

Study Description
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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.


Condition or disease Intervention/treatment
Dental Pulp Diseases Procedure: Root canal 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 Design
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Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Success and Survival of Teeth and Restoration Following Root Canal Treatment With Varying Degrees of Tooth Structure Loss Restored With CAD CAM Restorations.
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : November 1, 2020
Actual Study Completion Date : November 1, 2020
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Success of root canal treatment [ Time Frame: Upto 24 months ]
    Outcome of root canal treatment assessed using CBCT

  2. Survival of Ceramic Onlays [ Time Frame: Upto 24 months ]
    Survival of ceramic onlays assessed using modified USPHS criteria


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Routine patients requiring root canal treatment at Guy's Hospital, London
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378778


Locations
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United Kingdom
Guy's Hospital
London, United Kingdom, SE19RT
Sponsors and Collaborators
King's College London
Investigators
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Principal Investigator: Francesco Mannocci Professor of Endodontology
  Study Documents (Full-Text)

Documents provided by Professor Francesco Mannocci, King's College London:
Study Protocol  [PDF] October 30, 2017
Informed Consent Form  [PDF] November 6, 2017
Statistical Analysis Plan  [PDF] December 10, 2017

More Information
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Publications:

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Responsible Party: Professor Francesco Mannocci, Professor of Endodontology, King's College London
ClinicalTrials.gov Identifier: NCT03378778    
Other Study ID Numbers: IRAS Project ID: 224248
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual data for all primary and secondary outcome measurements will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases