One Vs Two Visits Root Canal Treatments in Infected Teeth
NCT ID: NCT04605445
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2020-11-18
2031-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1 visit endodontics
Root canal treatment is performed in one visit.
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.
2 visits endodontics
Root canal treatment is performed in two visits.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Norrbottens County Council
OTHER_GOV
Landstinget i Kalmar Län
OTHER
Blekinge County Council
UNKNOWN
Kronoberg County Council
OTHER_GOV
Odontologisk Forskning i Region Skåne (OFRS)
UNKNOWN
County Council of Halland, Sweden
OTHER_GOV
Smile Tandvård
UNKNOWN
Aragón Dental
UNKNOWN
Kalmar County Council
UNKNOWN
Oris Dental
UNKNOWN
Malmö University
OTHER
Responsible Party
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Annika E Björkner
Associate Professor
Locations
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Folktandvården Region Kronoberg
Vaxjo, Kronoberg County, Sweden
Folktandvården Region Norrbotten
Luleå, Norrbotten County, Sweden
Folktandvården Region Kalmar
Kalmar, , Sweden
Smile Tandvård
Luleå, , Sweden
Aragón Dental
Malmo, , Sweden
Oris Dental
Malmo, , Sweden
Folktandvården Region Halland
Varberg, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Veronica Asp Lockby
Role: primary
Fernando Mota de Almeida, PhD
Role: primary
Elin Lundgren, DDS
Role: backup
Elena Shmarina
Role: primary
Anna Gatu
Role: primary
Lars Armbäck, DDS
Role: backup
Veronica Aragón, DDS
Role: primary
Catherine Benavente Hansson, DDS
Role: primary
Maria Wattsgård
Role: primary
Other Identifiers
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EPN 2020-00207
Identifier Type: -
Identifier Source: org_study_id