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Clinical Trials/NCT05648305
NCT05648305CompletedNot Applicable

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

Defence Primary Health Care, UK0 sites1,267 target enrollmentStarted: January 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,267
Primary Endpoint
1. Tooth survival

Study Overview

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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.
  • Smoking and non-smoking patients
  • With and without Diabetes Mellitus 2
  • Taking/ not-taking steroid medications
  • With/ without other medical conditions.

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Defence Primary Health Care, UK
Sponsor Class
Other Gov
Responsible Party
Sponsor

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