Survival of Root Canal Treated Teeth Restored With Ceramic Onlays

Sponsor
King's College London (Other)
Overall Status
Completed
CT.gov ID
NCT03378778
Collaborator
(none)
125
1
34
3.7

Study Details

Study Description

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 Phase
  • 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

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 :
Jan 1, 2018
Actual Primary Completion Date :
Nov 1, 2020
Actual Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Success of root canal treatment [Upto 24 months]

    Outcome of root canal treatment assessed using CBCT

  2. Survival of Ceramic Onlays [Upto 24 months]

    Survival of ceramic onlays assessed using modified USPHS criteria

Secondary Outcome Measures

  1. Main types of failure of restoration. [Upto 24 months]

    Modified USPHS criteria will be used to identify the main types of failure of these restorations.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Guy's Hospital London United Kingdom SE19RT

Sponsors and Collaborators

  • King's College London

Investigators

  • Principal Investigator: Francesco Mannocci, Professor of Endodontology

Study Documents (Full-Text)

More Information

Publications

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:
Dec 20, 2017
Last Update Posted:
Dec 3, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2020