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Survival of Root Canal Treated Teeth Restored With Ceramic Onlays

NCT ID: NCT03378778

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-11-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dental Pulp Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Less than 33% Tooth Structure remaining

Root canal treatment followed by CAD CAM restoration

Root canal treatment

Intervention Type PROCEDURE

Root Canal Treatment followed by Ceramic Onlay restoration

33%-50% tooth structure remaining

Root canal treatment followed by CAD CAM restoration

Root canal treatment

Intervention Type PROCEDURE

Root Canal Treatment followed by Ceramic Onlay restoration

50% -66% tooth structure remaining

Root canal treatment followed by CAD CAM restoration

Root canal treatment

Intervention Type PROCEDURE

Root Canal Treatment followed by Ceramic Onlay restoration

More than 66% tooth structure remaining

Root canal treatment followed by CAD CAM restoration

Root canal treatment

Intervention Type PROCEDURE

Root Canal Treatment followed by Ceramic Onlay restoration

Interventions

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Root canal treatment

Root Canal Treatment followed by Ceramic Onlay restoration

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King's College London

OTHER

Sponsor Role lead

Responsible Party

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Professor Francesco Mannocci

Professor of Endodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesco Mannocci

Role: PRINCIPAL_INVESTIGATOR

Professor of Endodontology

Locations

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Guy's Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Al-Nuaimi N, Patel S, Austin RS, Mannocci F. A prospective study assessing the effect of coronal tooth structure loss on the outcome of root canal retreatment. Int Endod J. 2017 Dec;50(12):1143-1157. doi: 10.1111/iej.12760. Epub 2017 Apr 9.

Reference Type BACKGROUND
PMID: 28294354 (View on PubMed)

Beier US, Kapferer I, Burtscher D, Giesinger JM, Dumfahrt H. Clinical performance of all-ceramic inlay and onlay restorations in posterior teeth. Int J Prosthodont. 2012 Jul-Aug;25(4):395-402.

Reference Type BACKGROUND
PMID: 22720292 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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IRAS Project ID: 224248

Identifier Type: -

Identifier Source: org_study_id