Survival of Root Canal Treated Teeth Restored With Ceramic Onlays

Dental Pulp Diseases Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378778
• Other study ID #: IRAS Project ID: 224248
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: November 1, 2020

Study information

• Verified date: December 2020
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Diseases

Intervention

Procedure:
• Root canal treatment
Root Canal Treatment followed by Ceramic Onlay restoration

Locations

Country	Name	City	State
United Kingdom	Guy's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of root canal treatment	Outcome of root canal treatment assessed using CBCT	Upto 24 months
Primary	Survival of Ceramic Onlays	Survival of ceramic onlays assessed using modified USPHS criteria	Upto 24 months
Secondary	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