Dental Pulp DiseasesNCT03378778
Survival of Root Canal Treated Teeth Restored With Ceramic Onlays
An observational study of Dental Pulp Diseases, run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Diseases
- What is being tested?
- Root canal treatment
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2018to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Routine patients requiring root canal treatment at Guy's Hospital, London
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Dental Pulp Diseases
- Being tested
- Root canal treatment
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatmentProcedure or surgery
Root Canal Treatment followed by Ceramic Onlay restoration
| Study group | Role | What they receive |
|---|---|---|
| Less than 33% Tooth Structure remaining | Root canal treatment followed by CAD CAM restoration Receives: Procedure: Root canal treatment | |
| 33%-50% tooth structure remaining | Root canal treatment followed by CAD CAM restoration Receives: Procedure: Root canal treatment | |
| 50% -66% tooth structure remaining | Root canal treatment followed by CAD CAM restoration Receives: Procedure: Root canal treatment | |
| More than 66% tooth structure remaining | Root canal treatment followed by CAD CAM restoration Receives: Procedure: Root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of root canal treatment
Outcome of root canal treatment assessed using CBCT
Measured: Upto 24 months
Survival of Ceramic Onlays
Survival of ceramic onlays assessed using modified USPHS criteria
Measured: Upto 24 months
Secondary outcomes (1)
Main types of failure of restoration.
Modified USPHS criteria will be used to identify the main types of failure of these restorations.
Measured: Upto 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start1 Jan 2018
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental Pulp DiseasesStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Francesco Mannocci, King's College London
- Investigators
- Francesco Mannocci, Principal investigator, Professor of Endodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378778
- Sponsor's protocol ID
- IRAS Project ID: 224248
- Status last verified
- Dec 2020
- First submitted
- 5 Dec 2017
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data for all primary and secondary outcome measurements will be made available
Publications
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.
PubMed 28294354Beier 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.
PubMed 22720292
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03378778
- Acronym / sponsor ID
- IRAS Project ID: 224248
- Conditions
- Dental Pulp Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Less than 33% Tooth Structure remaining | – | Procedure: Root canal treatmentRoot canal treatment followed by CAD CAM restoration |
| 33%-50% tooth structure remaining | – | Procedure: Root canal treatmentRoot canal treatment followed by CAD CAM restoration |
| 50% -66% tooth structure remaining | – | Procedure: Root canal treatmentRoot canal treatment followed by CAD CAM restoration |
| More than 66% tooth structure remaining | – | Procedure: Root canal treatmentRoot canal treatment followed by CAD CAM restoration |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Routine patients requiring root canal treatment at Guy's Hospital, London
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Root canal treatmentRoot Canal Treatment followed by Ceramic Onlay restoration | Procedure or surgery | 33%-50% tooth structure remaining, 50% -66% tooth structure remaining, Less than 33% Tooth Structure remaining, More than 66% tooth structure remaining |
Primary outcome
Success of root canal treatment
Time frame: Upto 24 months
Outcome of root canal treatment assessed using CBCT
Survival of Ceramic Onlays
Time frame: Upto 24 months
Survival of ceramic onlays assessed using modified USPHS criteria
1 secondary outcome
Main types of failure of restoration.
Time frame: Upto 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Background: PubMed 28294354Al-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.
- Background: PubMed 22720292Beier 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.
- Individual participant dataSharing planned: Yes. De-identified individual data for all primary and secondary outcome measurements will be made available
Related trials for Dental Pulp Diseases
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Active, not recruiting
Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not?
Endodontically Treated Teeth, Calcium Hydroxide
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Mannocci principal investigator
Professor of Endodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Pulp Diseases, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of root canal treatment (time frame: Upto 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03378778, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.