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One vs Two Visits Root Canal Treatments in Infected Teeth

RecruitingNAAges 18 Years - anyAllMalmö University
NCT04605445 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • 1 visit root canal treatment (endodontics)
  • 2 visits root canal treatment (endodontics)
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Where

7 sites
Folktandvården Region Kronoberg
Vaxjo, Sweden
Folktandvården Region Norrbotten
Luleå, Sweden
Folktandvården Region Kalmar
Kalmar, Sweden
Smile Tandvård
Luleå, Sweden
Aragón Dental
Malmö, Sweden
Oris Dental
Malmö, Sweden
Folktandvården Region Halland
Varberg, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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