One Vs Two Visits Root Canal Treatments in Infected Teeth
One Vs Two Visits Endodontics - a Prospective Randomized Multicenter Study in General Dental Practice
1 other identifier
interventional
1,000
1 country
7
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
7 active sites
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
First Submitted
Initial submission to the registry
October 22, 2020
CompletedFirst Posted
Study publicly available on registry
October 28, 2020
CompletedStudy Start
First participant enrolled
November 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
December 16, 2024
November 1, 2024
7 years
October 22, 2020
December 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Periapical health at year 1
Assessment of apical radio-anatomical structures by two independent and blinded observers
One year after completed treatment
Periapical health at year 4
Assessment of apical radio-anatomical structures by two independent and blinded observers
Four years after completed treatment
Secondary Outcomes (6)
Post-operative pain 7 days
5-7 days post-operatively
Post-operative pain 30 days
30 days post-operatively
Medication intake
30 days post-operatively
Tooth survival at year 1
1 year after completed treatment
Tooth survival at year 4
4 year after completed treatment
- +1 more secondary outcomes
Study Arms (2)
1 visit endodontics
EXPERIMENTALRoot canal treatment is performed in one visit.
2 visits endodontics
ACTIVE COMPARATORRoot canal treatment is performed in two visits.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Malmö Universitylead
- Norrbottens County Councilcollaborator
- Landstinget i Kalmar Läncollaborator
- Blekinge County Councilcollaborator
- Kronoberg County Councilcollaborator
- Odontologisk Forskning i Region Skåne (OFRS)collaborator
- County Council of Halland, Swedencollaborator
- Smile Tandvårdcollaborator
- Aragón Dentalcollaborator
- Kalmar County Councilcollaborator
- Oris Dentalcollaborator
Study Sites (7)
Folktandvården Region Kronoberg
Vaxjo, Kronoberg County, 352 31, Sweden
Folktandvården Region Norrbotten
Luleå, Norrbotten County, 97128, Sweden
Folktandvården Region Kalmar
Kalmar, Sweden
Smile Tandvård
Luleå, Sweden
Aragón Dental
Malmo, Sweden
Oris Dental
Malmo, Sweden
Folktandvården Region Halland
Varberg, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 22, 2020
First Posted
October 28, 2020
Study Start
November 18, 2020
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2031
Last Updated
December 16, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share