Comparing one versus two visits for root canal treatments in infected teeth
One Vs Two Visits Endodontics - a Prospective Randomized Multicenter Study in General Dental Practice
This study is testing whether getting a root canal treatment in one visit is just as effective as getting it in two visits for people with infected teeth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Malmö University Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Vaxjo, Kronoberg County and 6 other locations) |
| Trial ID | NCT04605445 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the outcomes of one-visit versus two-visit root canal treatments for infected teeth in general dental practice. It will assess the success rates, root filling quality, and complication frequencies of both treatment approaches one and four years after the procedures. A pilot study will first identify any protocol shortcomings, followed by a multi-center approach involving several clinics across five counties in Sweden. The study will include eligible patients with necrotic teeth and will require a sample size of 356 patients per treatment group to detect statistically significant differences.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over 17 years old with a necrotic permanent tooth requiring endodontic treatment.
Not a fit: Patients with severe general diseases, systemic involvement, or those with specific dental conditions that complicate treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the most effective treatment approach for root canal procedures, potentially improving patient outcomes and reducing the need for multiple visits.
How similar studies have performed: Previous studies have explored similar treatment approaches, but this specific comparison of one versus two visits in a multi-center setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Vaxjo, Kronoberg County and 6 other locations
- Folktandvården Region Kronoberg — Vaxjo, Kronoberg County, Sweden (Recruiting)
- Folktandvården Region Norrbotten — Luleå, Norrbotten County, Sweden (Recruiting)
- Folktandvården Region Kalmar — Kalmar, Sweden (Not_yet_recruiting)
- Smile Tandvård — Luleå, Sweden (Recruiting)
- Aragón Dental — Malmö, Sweden (Not_yet_recruiting)
- Oris Dental — Malmö, Sweden (Not_yet_recruiting)
- Folktandvården Region Halland — Varberg, Sweden (Recruiting)
Study contacts
- Study coordinator: Annika Björkner, PhD
- Email: annika.bjorkner@mau.se
- Phone: +46-(0)40-6658532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.