One Vs Two Visits Root Canal Treatments in Infected Teeth

Malmö University

Status: Enrolling

Conditions: Apical Periodontitis; Dental Pulp Necrosis; Tooth Loss; Pain

Treatments: Procedure: 2 visits root canal treatment (endodontics); Procedure: 1 visit root canal treatment (endodontics)

Study type: Interventional

Funder types: Other

Identifiers

NCT04605445

EPN 2020-00207

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 2 patient groups

1 visit endodontics

Experimental group

Description:

Root canal treatment is performed in one visit.

Treatment:

Procedure: 1 visit root canal treatment (endodontics)

2 visits endodontics

Active Comparator group

Description:

Root canal treatment is performed in two visits.

Treatment:

Procedure: 2 visits root canal treatment (endodontics)