NCT05648305

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,267

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

5.7 years

First QC Date

December 5, 2022

Last Update Submit

December 12, 2022

Conditions

Keywords

Root Canal Treatment

Outcome Measures

Primary Outcomes (2)

  • 1. Tooth survival

    Tooth still present in the mouth at end of trial period.

    6-months - 48-months post-treatment.

  • 2. Root Canal Treatment Success

    The absence of signs, symptoms and evidence of radiographic peri-apical radiolucency resolution.

    6-months - 48-months post-treatment.

Study Arms (2)

General Dental Practitioners

Cohort 1 consisted UK Armed Forces Personnel that received root canal treatment within the study period by General Dental Practitioners.

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.

Procedure: Root Canal Treatment/ Re-treatment

Interventions

The provision of Root Canal Treatment for teeth with Endodontic infection or to prevent Endodontic infection.

Also known as: Endodontic Therapy
Dentists with Specialist Interest (DWSI)General Dental Practitioners

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and Female personnel serving within the UK Armed Forces that had received root canal treatment during the study period.

You may qualify if:

  • 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..
  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Dental Implantation, Endosseous, Endodontic

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationEndodonticsDentistryProsthodontics

Study Officials

  • Neil MacBeth, BDS PhD

    Defence Primary Healthcare

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 13, 2022

Study Start

January 1, 2015

Primary Completion

September 1, 2020

Study Completion

January 31, 2022

Last Updated

December 14, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

The data belongs to the UKAF. Requests for data sharing would require MOD approval.