Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-08 @ 6:41 AM
Study NCT ID:
NCT05648305
Status:
COMPLETED
Last Update Posted:
2022-12-14
First Post:
2022-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influences of Root Canal Complexity and Clinician Training on Root Canal Treatment Outcomes.
Sponsor:
Defence Primary Health Care, UK
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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:
1\. 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.
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:
1\. 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: