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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Less than 33% Tooth Structure remaining | Root canal treatment followed by CAD CAM restoration |
| |
| 33%-50% tooth structure remaining | Root canal treatment followed by CAD CAM restoration |
| |
| 50% -66% tooth structure remaining | Root canal treatment followed by CAD CAM restoration |
| |
| More than 66% tooth structure remaining | Root canal treatment followed by CAD CAM restoration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Root canal treatment | Procedure | Root Canal Treatment followed by Ceramic Onlay restoration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success of root canal treatment | Outcome of root canal treatment assessed using CBCT | Upto 24 months |
| Survival of Ceramic Onlays | Survival of ceramic onlays assessed using modified USPHS criteria | Upto 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Main types of failure of restoration. | Modified USPHS criteria will be used to identify the main types of failure of these restorations. | Upto 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Routine patients requiring root canal treatment at Guy's Hospital, London
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Mannocci | Professor of Endodontology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's Hospital | London | SE19RT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28294354 | Background | 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. | |
| 22720292 | Background | 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. |
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De-identified individual data for all primary and secondary outcome measurements will be made available
Data will be available within 6 months of study completion
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 30, 2017 | Dec 4, 2017 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 6, 2017 | Dec 4, 2017 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 10, 2017 | Dec 10, 2017 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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