Periapical PeriodontitisNCT03660163
Assessment of the Outcome of Endodontic Treatment Using Cone Beam Computed Tomography.
An observational study of Periapical Periodontitis, run by King's College London.
Trial summary
The aim of the study is to assess the correlation between pre-obturation bacterial detection using fluorescence amplification and outcome of endodontic treatments. Thus, enabling a suitable detection threshold to predict the likelihood of treatment failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periapical Periodontitis
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 1 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the endodontic postgraduate unit at Guy's Hospital.
Who may be able to join
- Patients with at least one tooth diagnosed with the endodontic disease.
- teeth that were tender to percussion and palpation.
- teeth that had a sinus tract and/ swelling.
- Both primary treatment teeth and teeth which had already been root treated were considered.
Who cannot join
- Patients were excluded if they were pregnant.
- Immunosuppressed patients.
- Non-restorable teeth.
- Teeth with a periodontal probing depth greater than 3mm.
- Teeth with apical radiolucencies with the longest dimension above 1.2cm.
About this study
Official title: Assessment of the Outcome of Endodontic Treatment Using Cone Beam Computed Tomography-A Prospective Study
The aim of the study is to assess the correlation between pre-obturation bacterial detection using fluorescence amplification and outcome of endodontic treatments. Thus, enabling a suitable detection threshold to predict the likelihood of treatment failure. This has the potential to be used a bench side tool in general dental practice to act as a surrogate endpoint for clinicians performing root canal treatment.
Read the detailed description
Pre-obturation root canal samples were taken using paper points from patients undergoing primary root treatments. The samples were analyzed using a fluorescent spectrometer and a molecular fluorescent vital dye (Calcein AM).
Pre-operative and 1-year post-operative periapical radiographs and Cone Beam Computed Tomography (CBCT) scans were assessed by two calibrated expert examiners to evaluate the outcome of the root canal treatments.
The use of a chairside bacterial stain can allow the clinician to predict the outcome of treatment with confidence. Sampling the root canal space with endodontic paper points followed by ex-situ fluorescent staining and analysis provides a patient-friendly, simple to use and rapid way of predicting root canal treatment outcome.
- Conditions
- Periapical Periodontitis
- Medical subject headings
- Periapical Periodontitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical periodontium health
Assess the health of periapical periodontium of a tooth by examining the CBCT image
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Nov 2016
- Primary completion1 Aug 2018
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periapical PeriodontitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shanon Patel, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660163
- Sponsor's protocol ID
- 08/H0804/79 v.3
- Status last verified
- Aug 2018
- First submitted
- 4 Sep 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Knight A, Blewitt I, Al-Nuaimi N, Watson T, Herzog D, Festy F, Patel S, Foschi F, Koller G, Mannocci F. Rapid Chairside Microbial Detection Predicts Endodontic Treatment Outcome. J Clin Med. 2020 Jul 3;9(7):2086. doi: 10.3390/jcm9072086.
PubMed 32635158
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Outcome of Endodontic Treatment Using Cone Beam Computed Tomography-A Prospective Study
- ClinicalTrials.gov ID
- NCT03660163
- Acronym / sponsor ID
- 08/H0804/79 v.3
- Conditions
- Periapical Periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 6 Sep 2018 (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.
The aim of the study is to assess the correlation between pre-obturation bacterial detection using fluorescence amplification and outcome of endodontic treatments. Thus, enabling a suitable detection threshold to predict the likelihood of treatment failure. This has the potential to be used a bench side tool in general dental practice to act as a surrogate endpoint for clinicians performing root canal treatment.
Detailed description
Pre-obturation root canal samples were taken using paper points from patients undergoing primary root treatments. The samples were analyzed using a fluorescent spectrometer and a molecular fluorescent vital dye (Calcein AM).
Pre-operative and 1-year post-operative periapical radiographs and Cone Beam Computed Tomography (CBCT) scans were assessed by two calibrated expert examiners to evaluate the outcome of the root canal treatments.
The use of a chairside bacterial stain can allow the clinician to predict the outcome of treatment with confidence. Sampling the root canal space with endodontic paper points followed by ex-situ fluorescent staining and analysis provides a patient-friendly, simple to use and rapid way of predicting root canal treatment outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the endodontic postgraduate unit at Guy's Hospital.
Key inclusion criteria (4 listed)
- Patients with at least one tooth diagnosed with the endodontic disease.
- teeth that were tender to percussion and palpation.
- teeth that had a sinus tract and/ swelling.
- Both primary treatment teeth and teeth which had already been root treated were considered.
Key exclusion criteria (5 listed)
- Patients were excluded if they were pregnant.
- Immunosuppressed patients.
- Non-restorable teeth.
- Teeth with a periodontal probing depth greater than 3mm.
- Teeth with apical radiolucencies with the longest dimension above 1.2cm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Periapical periodontium health
Time frame: One year
Assess the health of periapical periodontium of a tooth by examining the CBCT image
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Derived from this study: PubMed 32635158Knight A, Blewitt I, Al-Nuaimi N, Watson T, Herzog D, Festy F, Patel S, Foschi F, Koller G, Mannocci F. Rapid Chairside Microbial Detection Predicts Endodontic Treatment Outcome. J Clin Med. 2020 Jul 3;9(7):2086. doi: 10.3390/jcm9072086.
Related trials for Periapical Periodontitis
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Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
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Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
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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
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Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
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.
Shanon Patel, PhD principal investigator
King's College London
Questions about this trial
What is this clinical trial studying?
An observational study of Periapical Periodontitis, run by King's College London.
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 5 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: status not confirmed, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Periapical periodontium health (time frame: One year). 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 NCT03660163, which also lists 1 linked publication.
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 7 Sep 2018.