An interventional study of 1 visit root canal treatment (endodontics) and 2 visits root canal treatment (endodontics) in Apical Periodontitis, Pain and Tooth Loss, sponsored by Malmö University. Recruiting at 7 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Malmö University · Not applicable, Interventional, and Treatment
The primary aim of the study is to compare the outcome of one vs two visits endodontics (root canal treatments) performed in general dental practice of infected (necrotic) teeth, one and four years after treatment. Secondary aims are to compare the root filling quality and the frequency of complications for both treatment modalities.
A pilot study will identify the shortcomings of the protocol, which will be revised accordingly.
A multi-center study in several clinics from five counties throughout Sweden is planned. Consecutive eligible patients (see inclusion and exclusion criteria) with one tooth each will be included.
The study sample size calculation was based on a judgement that a minimal worthwhile effect of less than 10% was not clinically relevant. The presumption was that successful outcomes would be of 75% and 65% for the different treatment arms, respectively. Three hundred and fifty six patients per group are thus needed to detect that difference as statistical significant with a power of 80% and an alfa-error of 5%. To compensate for around 30% drop-outs a number of 1000 patients will be recruited.
Patients will be randomly enrolled in two arms: one in which the endodontic treatment (root canal treatment) is performed in one visit, and in the other arm in two visits. The allocation sequences for one vs multiple visit endodontics will be computer generated followed by a dark colored envelope concealed allocation.
The patients will be contacted by telephone 5-7 days post-operatively, and a control visit at the clinic will be scheduled one month post-operatively to assess complications related to the treatment.
A clinical control will be performed at the clinic one and four years after treatment. Intra-oral radiographs will be taken. The radiographs will be examined by two blinded and independent observers. A successful outcome is defined by clinical and radiographic normalcy.
The statistical methods selected to analyse the primary outcome will be the Chi square test of 2x2 tables, or Fisher´s exact test when proportions are small and the expected value \<5. The calculations will be two-tailed. Results will be considered statistically significant at p\<0.05.
280 studies on the registry are indexed under Periapical Periodontitis; 79 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 60 across 245 interventional studies indexed under Periapical Periodontitis.
Browse Periapical Periodontitis studies →Malmö University is the lead sponsor of 44 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Root canal treatment is performed in one visit.
Procedure: 1 visit root canal treatment (endodontics)
Root canal treatment is performed in two visits.
Procedure: 2 visits root canal treatment (endodontics)
Endodontics (root canal treatment). In the enrolment visit, access, opening and identification of root canals can be performed and a suitable temporization will be placed in the tooth if needed. Root canal treatment can be completed in the same visit or performed in another visit where cleaning, shaping and root filling procedures, temporization or permanent restoration will be performed. These procedures are part of the normal clinical praxis. No rigid protocol will be implemented, as a pragmatic design was chosen.
Endodontics (root canal treatment). In the enrolment visit, access, opening and identification of root canals can be performed and a suitable temporization will be placed in the tooth if needed. Root canal treatment can be started, or performed in another visit, lasting 2 visits. In the first visit cleaning and shaping is performed and a medication is put in place in the canals, and the tooth is temporized until the next visit at least one week apart. In the second visit the tooth is root filled and temporization or permanent restoration will be performed. These procedures are part of the normal clinical praxis. No rigid protocol will be implemented, as a pragmatic design was chosen.
Periapical health at year 1
Assessment of apical radio-anatomical structures by two independent and blinded observers
Time frame: One year after completed treatment
Periapical health at year 4
Assessment of apical radio-anatomical structures by two independent and blinded observers
Time frame: Four years after completed treatment
Post-operative pain 7 days
Patient self-reported pain at an numeric rating scale from 0 (no pain) to 10 (worst pain imaginable)
Time frame: 5-7 days post-operatively
Post-operative pain 30 days
Patient self-reported pain at an numeric rating scale from 0 (no pain) to 10 (worst pain imaginable)
Time frame: 30 days post-operatively
Medication intake
Patient self-reported analgesic and antibiotic intake
Time frame: 30 days post-operatively
Tooth survival at year 1
Presence of root-filled tooth
Time frame: 1 year after completed treatment
Tooth survival at year 4
Presence of root-filled tooth
Time frame: 4 year after completed treatment
Complications
Complications not previously described that can be associated with endodontic treatment
Time frame: 30 days and long-term follow-up at year 1 and 4
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2020 (actual). Primary completion is estimated for Dec 2030, 121 months after the start.
Of 171 non-industry interventional studies with no phase under Periapical Periodontitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's planned 121 months is above that.
Counting every sponsor, half of 172 studies reached it within 12 months; a quarter within 6 and three quarters within 19.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 13, 2026: primary completion Dec 2027 → Dec 2030 and completion Dec 2031 → Dec 2034.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Malmö University