Clinical trial NCT04605445: One Vs Two Visits Root Canal Treatments in Infected Teeth
Official title: One Vs Two Visits Endodontics - a Prospective Randomized Multicenter Study in General Dental Practice
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Apical Periodontitis
Pain
Tooth Loss
Dental Pulp Necrosis
Keywords: Endodontics
General Dental Practice
Single Visit
Multiple Visits
Infection Barrier
Lead sponsor: Malmö University
Sponsor class: OTHER
Collaborators: name: Norrbottens County Council
name: Landstinget i Kalmar Län
name: Blekinge County Council
name: Kronoberg County Council
name: Odontologisk Forskning i Region Skåne (OFRS)
name: County Council of Halland, Sweden
name: Smile Tandvård
name: Aragón Dental
name: Kalmar County Council
name: Oris Dental
First posted: 2020-10-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Periapical health at year 1
timeFrame: One year after completed treatment
measure: Periapical health at year 4
timeFrame: Four years after completed treatment
Secondary outcomes:
measure: Post-operative pain 7 days
timeFrame: 5-7 days post-operatively
measure: Post-operative pain 30 days
timeFrame: 30 days post-operatively
measure: Medication intake
timeFrame: 30 days post-operatively
measure: Tooth survival at year 1
timeFrame: 1 year after completed treatment
measure: Tooth survival at year 4
timeFrame: 4 year after completed treatment
measure: Complications
timeFrame: 30 days and long-term follow-up at year 1 and 4
Other outcomes:
Locations:
city: Växjö
country: Sweden
facility: Folktandvården Region Kronoberg
state: Kronoberg
city: Luleå
country: Sweden
facility: Folktandvården Region Norrbotten
state: Norrbotten
city: Kalmar
country: Sweden
facility: Folktandvården Region Kalmar
city: Luleå
country: Sweden
facility: Smile Tandvård
city: Malmö
country: Sweden
facility: Aragón Dental
city: Malmö
country: Sweden
facility: Oris Dental
city: Varberg
country: Sweden
facility: Folktandvården Region Halland
Study officials:
References: