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OpenTrials
Completed

NCT Number: NCT03378778

Survival of Root Canal Treated Teeth Restored With Ceramic Onlays

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.

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Key information

Conditions

Dental Pulp Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guy's Hospital

London, SE19RT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Root canal treatment

Procedure

Root Canal Treatment followed by Ceramic Onlay restoration

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 20, 2017
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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