Apical PeriodontitisNCT04605445
One vs Two Visits Root Canal Treatments in Infected Teeth
A study testing 1 visit root canal treatment (endodontics) and 2 visits root canal treatment (endodontics) in people with Apical Periodontitis and Pain, run by Malmö University at 7 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apical Periodontitis, Pain, Tooth Loss
- What is being tested?
- 1 visit root canal treatment (endodontics) and 2 visits root canal treatment (endodontics)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 7 sitesSweden
- Study dates
- 18 Nov 2020to Dec 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient older than 17 years.
- Permanent tooth excluding third molars.
- Necrotic tooth with/without clinical and/or radiological signs of apical (juxta radicular) periodontitis (non-bleeding pulp in the canal orifice. In case of a multi rooted tooth, a non-bleeding pulp in at least one root canal orifice) where orthograde endodontic treatment is planned.
Who cannot join
- Patients with severe general disease and/ or where endodontic treatment requires special consideration for health reasons (eg radiation-treated jaw bone in the area or increased susceptibility to infection).
- Systemic involvement (fever).
- Swelling (extra- and/or intra oral).
- Previously root canal treated tooth (instrumented and/or rotfilled).
- Confirmed or strong suspicion of transverse or longitudinal root fracture.
- Trauma to the tooth (<6 month).
Show all 11Show fewer
- Marginal bone loss >1/3 of the root lenght.
- Root resorption.
- Non restorable tooth.
- Endodontic treatment is not considered feasible because rubberdam cannot be used on the tooth.
- Follow-up at the clinic of the treatment after> 1 year is considered not feasible.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Sweden7 sites, 7 recruiting
- Not yet recruiting
Folktandvården Region Kalmar
Kalmar
Elena Shmarina
- Recruiting
Folktandvården Region Norrbotten
Luleå, Norrbotten County, 97128
Fernando Mota de Almeida, PhD, 0046-920-71975, fernando.mota-de-almeida@norrbotten.se
Elin Lundgren, DDS, elin.s.lundgren@norrbotten.se
- Recruiting
Smile Tandvård
Luleå
Anna Gatu, anna.gatu@smile.se
Lars Armbäck, DDS, Lars.armback@smile.se
- Not yet recruiting
Aragón Dental
Malmö
Veronica Aragón, DDS
- Not yet recruiting
Oris Dental
Malmö
Catherine Benavente Hansson, DDS
- Recruiting
Folktandvården Region Halland
Varberg
Maria Wattsgård, +46-(0)340-48 23 00, Maria.Wattsgard@regionhalland.se
- Recruiting
Folktandvården Region Kronoberg
Vaxjo, Kronoberg County, 352 31
Veronica Asp Lockby
About this study
Official title: One vs Two Visits Endodontics - a Prospective Randomized Multicenter Study in General Dental Practice
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.
Read more
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.
- Conditions
- Apical Periodontitis, Pain, Tooth Loss, Dental Pulp Necrosis
- Being tested
- 1 visit root canal treatment (endodontics), 2 visits root canal treatment (endodontics)
- Keywords
- Endodontics, General Dental Practice, Single Visit, Multiple Visits, Infection Barrier
- Medical subject headings
- Periapical Periodontitis, Pain, Tooth Loss, Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 visit root canal treatment (endodontics)Procedure or surgery
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.
2 visits root canal treatment (endodontics)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 visit endodontics | Experimental | Root canal treatment is performed in one visit. Receives: Procedure: 1 visit root canal treatment (endodontics) |
| 2 visits endodontics | Active comparator | Root canal treatment is performed in two visits. Receives: Procedure: 2 visits root canal treatment (endodontics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical health at year 1
Assessment of apical radio-anatomical structures by two independent and blinded observers
Measured: One year after completed treatment
Periapical health at year 4
Assessment of apical radio-anatomical structures by two independent and blinded observers
Measured: Four years after completed treatment
Secondary outcomes (6)
Post-operative pain 7 days
Patient self-reported pain at an numeric rating scale from 0 (no pain) to 10 (worst pain imaginable)
Measured: 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)
Measured: 30 days post-operatively
Medication intake
Patient self-reported analgesic and antibiotic intake
Measured: 30 days post-operatively
Tooth survival at year 1
Presence of root-filled tooth
Measured: 1 year after completed treatment
Tooth survival at year 4
Presence of root-filled tooth
Measured: 4 year after completed treatment
Complications
Complications not previously described that can be associated with endodontic treatment
Measured: 30 days and long-term follow-up at year 1 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start18 Nov 2020
- Primary completionDec 2030 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Collaborators
- Norrbottens County Council, Landstinget i Kalmar Län, Blekinge County Council, Kronoberg County Council, Region Skane, County Council of Halland, Sweden, Smile Tandvård, Aragón Dental, Region Kalmar County
- Responsible party
- Principal investigator, Annika E Björkner, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605445
- Sponsor's protocol ID
- EPN 2020-00207
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2020
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One vs Two Visits Endodontics - a Prospective Randomized Multicenter Study in General Dental Practice
- ClinicalTrials.gov ID
- NCT04605445
- Acronym / sponsor ID
- EPN 2020-00207
- Conditions
- Apical Periodontitis, Pain, Tooth Loss, Dental Pulp Necrosis
- Keywords
- Endodontics, General Dental Practice, Single Visit, Multiple Visits, Infection Barrier
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Collaborators
- Norrbottens County Council, Landstinget i Kalmar Län, Blekinge County Council, Kronoberg County Council, Region Skane, County Council of Halland, Sweden, Smile Tandvård, Aragón Dental, Region Kalmar County
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 visit endodontics | Experimental | Procedure: 1 visit root canal treatment (endodontics)Root canal treatment is performed in one visit. |
| 2 visits endodontics | Active comparator | Procedure: 2 visits root canal treatment (endodontics)Root canal treatment is performed in two visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient older than 17 years.
- Permanent tooth excluding third molars.
- Necrotic tooth with/without clinical and/or radiological signs of apical (juxta radicular) periodontitis (non-bleeding pulp in the canal orifice. In case of a multi rooted tooth, a non-bleeding pulp in at least one root canal orifice) where orthograde endodontic treatment is planned.
Key exclusion criteria (11 listed)
- Patients with severe general disease and/ or where endodontic treatment requires special consideration for health reasons (eg radiation-treated jaw bone in the area or increased susceptibility to infection).
- Systemic involvement (fever).
- Swelling (extra- and/or intra oral).
- Previously root canal treated tooth (instrumented and/or rotfilled).
- Confirmed or strong suspicion of transverse or longitudinal root fracture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 visit 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. | Procedure or surgery | 1 visit endodontics |
| 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 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. | Procedure or surgery | 2 visits endodontics |
Primary outcome
Periapical health at year 1
Time frame: One year after completed treatment
Assessment of apical radio-anatomical structures by two independent and blinded observers
Periapical health at year 4
Time frame: Four years after completed treatment
Assessment of apical radio-anatomical structures by two independent and blinded observers
6 secondary outcomes
Post-operative pain 7 days
Time frame: 5-7 days post-operatively
Post-operative pain 30 days
Time frame: 30 days post-operatively
Medication intake
Time frame: 30 days post-operatively
Tooth survival at year 1
Time frame: 1 year after completed treatment
Tooth survival at year 4
Time frame: 4 year after completed treatment
Complications
Time frame: 30 days and long-term follow-up at year 1 and 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 visit root canal treatment (endodontics) and 2 visits root canal treatment (endodontics) in people with Apical Periodontitis and Pain, run by Malmö University at 7 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annika Björkner, PhD (+46-(0)40-6658532, annika.bjorkner@mau.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periapical health at year 1 (time frame: One year after completed treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.