One Vs Two Visits Root Canal Treatments in Infected Teeth
- Conditions
- Apical PeriodontitisPainTooth LossDental Pulp Necrosis
- Interventions
- Procedure: 2 visits root canal treatment (endodontics)Procedure: 1 visit root canal treatment (endodontics)
- Registration Number
- NCT04605445
- Lead Sponsor
- Malmö University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 visits endodontics 2 visits root canal treatment (endodontics) Root canal treatment is performed in two visits. 1 visit endodontics 1 visit root canal treatment (endodontics) Root canal treatment is performed in one visit.
- Primary Outcome Measures
Name Time Method Periapical health at year 1 One year after completed treatment Assessment of apical radio-anatomical structures by two independent and blinded observers
Periapical health at year 4 Four years after completed treatment Assessment of apical radio-anatomical structures by two independent and blinded observers
- Secondary Outcome Measures
Name Time Method Tooth survival at year 4 4 year after completed treatment Presence of root-filled tooth
Complications 30 days and long-term follow-up at year 1 and 4 Complications not previously described that can be associated with endodontic treatment
Post-operative pain 7 days 5-7 days post-operatively Patient self-reported pain at an numeric rating scale from 0 (no pain) to 10 (worst pain imaginable)
Post-operative pain 30 days 30 days post-operatively Patient self-reported pain at an numeric rating scale from 0 (no pain) to 10 (worst pain imaginable)
Medication intake 30 days post-operatively Patient self-reported analgesic and antibiotic intake
Tooth survival at year 1 1 year after completed treatment Presence of root-filled tooth
Trial Locations
- Locations (7)
Smile Tandvård
🇸🇪Luleå, Sweden
Folktandvården Region Kronoberg
🇸🇪Växjö, Kronoberg, Sweden
Folktandvården Region Norrbotten
🇸🇪Luleå, Norrbotten, Sweden
Folktandvården Region Kalmar
🇸🇪Kalmar, Sweden
Oris Dental
🇸🇪Malmö, Sweden
Aragón Dental
🇸🇪Malmö, Sweden
Folktandvården Region Halland
🇸🇪Varberg, Sweden