Root Canal InfectionNCT05648305
The Influences of Root Canal Complexity and Clinician Training on Root Canal Treatment Outcomes.
An observational study of Root Canal Infection, run by Defence Primary Health Care, UK.
Trial summary
This is an observational study that assess the impacts of (a) root canal treatment complexity and (b) clinical training on (1) root canal treatment success and (2) tooth survival, in a United Kingdom Armed Forces cohort. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Root Canal Infection
- What is being tested?
- Root Canal Treatment/ Re-treatment
- Type of treatment
- Surgery or procedure
- How many people
- 1,267 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Jan 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and Female personnel serving within the UK Armed Forces that had received root canal treatment during the study period.
Who may be able to join
- Served/ were serving within the UK Armed Forces.
- Male and female.
- Physically able to tolerate root canal treatment/ re-treatment procedures.
- Received root canal treatment/ re-treatment for Endodontic disease by either a GDP or Dentist with Specialist interest (DWSI).
- Aged between 18 - 70..
- 12-month (or longer) post root canal treatment review radiograph and consultation.
Show all 10Show fewer
- Smoking and non-smoking patients
- With and without Diabetes Mellitus 2
- Taking/ not-taking steroid medications
- With/ without other medical conditions.
Who cannot join
- On longer serving in the military within 12-months of root canal treatment completion.
- Unable to tolerate root canal treatment/ re-treatment
- No clinical follow-up of tooth (survival).
- No radiographic follow-up of tooth (success).
About this study
Official title: Root Canal Treatment is a Common Intervention for Military Patients Suffering From- or at Risk of Suffering From- Endodontic Disease. This Retrospective Cohort Study Assesses the Influence of (a) Root Canal Complexity Using the Restorative Index of Treatment Need (RIOTN) Index and (b) Operator Skill (Clinicians Who Had Received Additional Post-graduate Root Canal Treatment Training, on Survival (Tooth Present at End of Study Period) and Success (Radiographic Apical Healing) of Root Canal Treatment
This is an observational study that assess the impacts of (a) root canal treatment complexity and (b) clinical training on (1) root canal treatment success and (2) tooth survival, in a United Kingdom Armed Forces cohort.
Read the detailed description
Background and Study Aims. This observational cohort study evaluates root canal treatment outcomes, using survival and success as the outcome measures. It aims to assess the influence of operator skill and RIOTN complexity on the clinical outcomes of RCT procedures previously undertaken within the UK Armed Forces.
Participation UK Armed Forces personnel that had previously received root canal treatment between 01/01/2015 and 01/09/2020.
Method
A Defence Statistics programme was used to identify cohorts of patients treated for Endodontic disease by GDPs and DWSI (GDPs who had undertaken a 1 year post-graduate training programme in Endodontics). The researcher group was calibrated to the study's method and this was initially piloted on 5 patient records, with further calibration undertaken until researcher consistency was achieved via inter-operator reliability testing. The researchers subsequently reviewed 1600 patient records, eventually establishing a cohort of 1267 patients (580 - Group 1 (GDP) and 687 - Group 2 (DWSI). The clinical records and radiographs of these groups were reviewed for the following:
- Tooth survival 2. RIOTN complexity at the time of treatment 3. RCT success (apical healing). Secondary factors assessed included: age, gender, smoking status, diabetic status, steroid status, presence of an indirect restoration, presence of a post, reasons for tooth loss (if tooth did not survive).
The collection of data has now been completed and is ready for analysis.
Risks and Benefits This study will benefit Defence Primary HealthCare and UKAF personnel as it will influence and shape future care provision for Endodontic disease within the military. There are no identified risks of participation.
Study Location The study is being run from the Defence Centre for Rehabilitative Dentistry, Evelyn Woods Road, Aldershot, GU11 2LS. The study is evaluation the outcomes of clinical practitioners working within the 200+ Dental Centres within the UK and overseas locations.
Funding There is no established funding for this study. There are no commercial or other conflicts of interest.
- Conditions
- Root Canal Infection
- Being tested
- Root Canal Treatment/ Re-treatment
- Keywords
- Root Canal Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root Canal Treatment/ Re-treatmentProcedure or surgery
Also called Endodontic Therapy
The provision of Root Canal Treatment for teeth with Endodontic infection or to prevent Endodontic infection.
| Study group | Role | What they receive |
|---|---|---|
| General Dental Practitioners | Cohort 1 consisted UK Armed Forces Personnel that received root canal treatment within the study period by General Dental Practitioners. Receives: Procedure: Root Canal Treatment/ Re-treatment | |
| Dentists with Specialist Interest (DWSI) | Cohort 2 consisted UK Armed Forces Personnel that received root canal treatment within the study period by DWSI, clinicians that had undertaken a 1-year post-graduate programme in Endodontics. Receives: Procedure: Root Canal Treatment/ Re-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Tooth survival
Tooth still present in the mouth at end of trial period.
Measured: 6-months - 48-months post-treatment.
2. Root Canal Treatment Success
The absence of signs, symptoms and evidence of radiographic peri-apical radiolucency resolution.
Measured: 6-months - 48-months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Jan 2015
- Primary completion1 Sep 2020
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal InfectionStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 1,267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Defence Primary Health Care, UK
- Sponsor type
- Other government
- Collaborators
- Eastman Dental Insitute and Hospital
- Responsible party
- Sponsor
- Investigators
- Neil MacBeth, BDS PhD, Study chair, Defence Primary Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648305
- Sponsor's protocol ID
- DefencePHC
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data belongs to the UKAF. Requests for data sharing would require MOD approval.
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Root Canal Treatment is a Common Intervention for Military Patients Suffering From- or at Risk of Suffering From- Endodontic Disease. This Retrospective Cohort Study Assesses the Influence of (a) Root Canal Complexity Using the Restorative Index of Treatment Need (RIOTN) Index and (b) Operator Skill (Clinicians Who Had Received Additional Post-graduate Root Canal Treatment Training, on Survival (Tooth Present at End of Study Period) and Success (Radiographic Apical Healing) of Root Canal Treatment
- ClinicalTrials.gov ID
- NCT05648305
- Acronym / sponsor ID
- DefencePHC
- Conditions
- Root Canal Infection
- Keywords
- Root Canal Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,267 participants (actual)
- Lead sponsor
- Defence Primary Health Care, UKOther government
- Collaborators
- Eastman Dental Insitute and Hospital
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 13 Dec 2022 (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.
This is an observational study that assess the impacts of (a) root canal treatment complexity and (b) clinical training on (1) root canal treatment success and (2) tooth survival, in a United Kingdom Armed Forces cohort.
Detailed description
Background and Study Aims. This observational cohort study evaluates root canal treatment outcomes, using survival and success as the outcome measures. It aims to assess the influence of operator skill and RIOTN complexity on the clinical outcomes of RCT procedures previously undertaken within the UK Armed Forces.
Participation UK Armed Forces personnel that had previously received root canal treatment between 01/01/2015 and 01/09/2020.
Method
A Defence Statistics programme was used to identify cohorts of patients treated for Endodontic disease by GDPs and DWSI (GDPs who had undertaken a 1 year post-graduate training programme in Endodontics). The researcher group was calibrated to the study's method and this was initially piloted on 5 patient records, with further calibration undertaken until researcher consistency was achieved via inter-operator reliability testing. The researchers subsequently reviewed 1600 patient records, eventually establishing a cohort of 1267 patients (580 - Group 1 (GDP) and 687 - Group 2 (DWSI). The clinical records and radiographs of these groups were reviewed for the following:
- Tooth survival 2. RIOTN complexity at the time of treatment 3. RCT success (apical healing). Secondary factors assessed included: age, gender, smoking status, diabetic status, steroid status, presence of an indirect restoration, presence of a post, reasons for tooth loss (if tooth did not survive).
The collection of data has now been completed and is ready for analysis.
Risks and Benefits This study will benefit Defence Primary HealthCare and UKAF personnel as it will influence and shape future care provision for Endodontic disease within the military. There are no identified risks of participation.
Study Location The study is being run from the Defence Centre for Rehabilitative Dentistry, Evelyn Woods Road, Aldershot, GU11 2LS. The study is evaluation the outcomes of clinical practitioners working within the 200+ Dental Centres within the UK and overseas locations.
Funding There is no established funding for this study. There are no commercial or other conflicts of interest.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Dental Practitioners | – | Procedure: Root Canal Treatment/ Re-treatmentCohort 1 consisted UK Armed Forces Personnel that received root canal treatment within the study period by General Dental Practitioners. |
| Dentists with Specialist Interest (DWSI) | – | Procedure: Root Canal Treatment/ Re-treatmentCohort 2 consisted UK Armed Forces Personnel that received root canal treatment within the study period by DWSI, clinicians that had undertaken a 1-year post-graduate programme in Endodontics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and Female personnel serving within the UK Armed Forces that had received root canal treatment during the study period.
Key inclusion criteria (10 listed)
- Served/ were serving within the UK Armed Forces.
- Male and female.
- Physically able to tolerate root canal treatment/ re-treatment procedures.
- Received root canal treatment/ re-treatment for Endodontic disease by either a GDP or Dentist with Specialist interest (DWSI).
- Aged between 18 - 70..
Key exclusion criteria (4 listed)
- On longer serving in the military within 12-months of root canal treatment completion.
- Unable to tolerate root canal treatment/ re-treatment
- No clinical follow-up of tooth (survival).
- No radiographic follow-up of tooth (success).
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 Treatment/ Re-treatmentAlso: Endodontic TherapyThe provision of Root Canal Treatment for teeth with Endodontic infection or to prevent Endodontic infection. | Procedure or surgery | Dentists with Specialist Interest (DWSI), General Dental Practitioners |
Primary outcome
1. Tooth survival
Time frame: 6-months - 48-months post-treatment.
Tooth still present in the mouth at end of trial period.
2. Root Canal Treatment Success
Time frame: 6-months - 48-months post-treatment.
The absence of signs, symptoms and evidence of radiographic peri-apical radiolucency resolution.
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 14 Dec 2022.
- Individual participant dataSharing planned: No. The data belongs to the UKAF. Requests for data sharing would require MOD approval.
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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.
Neil MacBeth, BDS PhD study chair
Defence Primary Healthcare
Questions about this trial
What is this clinical trial studying?
An observational study of Root Canal Infection, run by Defence Primary Health Care, UK.
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 10 inclusion and 4 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 14 Dec 2022. 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?
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?
1. Tooth survival (time frame: 6-months - 48-months post-treatment.). 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?
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 14 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.