NCT07244250

Brief Summary

Each year, nearly 200,000 teeth undergo root canal treatment in Sweden, most of them within general dental care. However, studies that evaluate the outcomes of root canal treatments have almost exclusively been conducted at specialist or university clinics, where treatment conditions differ from everyday practice in general dentistry. Moreover, the design of such studies often limits the ability to generalize their findings to routine clinical settings. These earlier studies suggest that root canal treatment is a predictable procedure-about 80-90% of treated teeth become free from infection, 90% of patients experience no pain, and approximately 90% of root-filled teeth remain in the mouth six years after treatment. Still, the results from these studies cannot easily be applied to general dental care. This has been confirmed by large-scale epidemiological studies using X-rays to assess the technical quality of performed root fillings and to detect signs of disease. These studies have shown that many root fillings exhibit technical shortcomings, and a significant proportion of root-treated teeth have persistent infections. The current study aims to increase understanding of the factors that may explain why the results of root canal treatment in general dental practice appear to differ from those in specialist care. Based on epidemiological data, it is estimated that about 35% of teeth treated with root canal therapy in general dental practice still show signs of disease after treatment. What happens to these patients is largely unknown. Evidence suggests that teeth with persistent apical periodontitis rarely cause discomfort, and the condition often goes unnoticed. In the first part of the study, only patients who have already received treatment will be invited to participate, making this a retrospective study. Because it takes several years to evaluate the outcome of a root canal treatment, all patients aged 20 years and older who had a tooth root-filled in 2023 within the Public Dental Services of Jönköping, Kalmar, or Östergötland counties will be offered a free clinical and radiological examination-thus a three-year follow-up. The examination is entirely painless. In the second part of the study, patients with a root-filled tooth showing persistent disease will be offered a five-year follow-up (2026-2031). They will be grouped according to whether they choose to have further treatment or leave the condition untreated. This second phase will therefore constitute a prospective follow-up.

Trial Health

65
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Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Mar 2026

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

November 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 16, 2025

Status Verified

October 1, 2025

Enrollment Period

10 months

First QC Date

November 17, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

Root canal treatmentApical periodontitisRoot filling

Outcome Measures

Primary Outcomes (2)

  • Posttreatment frequency of apical periodontitis

    Apical periodontitis as defined as a periapcal radiolucency on an intra oral radiograph

    three year follow-up

  • Posttreatment frequency of apical periodontitis

    Apical periodontitis as defined as a periapical radiolucency

    From completion of treatment to three year follow-up

Study Arms (1)

Patients

Patients who have received root canal treatment in the Public Dental Service in the counties of Jönköping, Kalmar and Östergötland

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who have received and completed a root canal treatment in the Public Dental Service in the counties of Jönköping, Kalmar and Östergötland in 2023.

You may qualify if:

  • All patients who have received and completed a root canal treatment in the Public Dental Service in the counties of Jönköping, Kalmar and Östergötland in 2023.

You may not qualify if:

  • All patients who decline participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Central Study Contacts

Fredrik Frisk, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
8 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 24, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

December 16, 2025

Record last verified: 2025-10