One vs Two Visits Root Canal Treatments in Infected Teeth

Pain Clinical Trial

Official title:

One vs Two Visits Endodontics - a Prospective Randomized Multicenter Study in General Dental Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04605445
• Other study ID #: EPN 2020-00207
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2020
• Est. completion date: December 2027

Study information

• Verified date: April 2023
• Source: Malmö University
• Contact: Annika Björkner, PhD
• Phone: +46-(0)40-6658532
• Email: annika.bjorkner[@]mau.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2027
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apical Periodontitis
• Dental Pulp Necrosis
• Necrosis
• Pain
• Periapical Periodontitis
• Periodontitis
• Tooth Loss

Intervention

Procedure:
• 1 visit root canal treatment (endodontics)
Endodontics (root canal treatment). In the enrolment visit, access, opening and identification of root canals can be performed and a suitable temporization will be placed in the tooth if needed. Root canal treatment can be completed in the same visit or performed in another visit where cleaning, shaping and root filling procedures, temporization or permanent restoration will be performed. These procedures are part of the normal clinical praxis. No rigid protocol will be implemented, as a pragmatic design was chosen.
• 2 visits root canal treatment (endodontics)
Endodontics (root canal treatment). In the enrolment visit, access, opening and identification of root canals can be performed and a suitable temporization will be placed in the tooth if needed. Root canal treatment can be started, or performed in another visit, lasting 2 visits. In the first visit cleaning and shaping is performed and a medication is put in place in the canals, and the tooth is temporized until the next visit at least one week apart. In the second visit the tooth is root filled and temporization or permanent restoration will be performed. These procedures are part of the normal clinical praxis. No rigid protocol will be implemented, as a pragmatic design was chosen.

Locations

Country	Name	City	State
Sweden	Folktandvården Region Kalmar	Kalmar
Sweden	Folktandvården Region Norrbotten	Luleå	Norrbotten
Sweden	Smile Tandvård	Luleå
Sweden	Aragón Dental	Malmö
Sweden	Oris Dental	Malmö
Sweden	Folktandvården Region Halland	Varberg
Sweden	Folktandvården Region Kronoberg	Växjö	Kronoberg

Sponsors (11)

Lead Sponsor	Collaborator
Malmö University	Aragón Dental, Blekinge County Council, County Council of Halland, Sweden, Kalmar County Council, Kronoberg County Council, Landstinget i Kalmar Län, Norrbottens County Council, Odontologisk Forskning i Region Skåne (OFRS), Oris Dental, Smile Tandvård

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periapical health at year 1	Assessment of apical radio-anatomical structures by two independent and blinded observers	One year after completed treatment
Primary	Periapical health at year 4	Assessment of apical radio-anatomical structures by two independent and blinded observers	Four years after completed treatment
Secondary	Post-operative pain 7 days	Patient self-reported pain at an numeric rating scale from 0 (no pain) to 10 (worst pain imaginable)	5-7 days post-operatively
Secondary	Post-operative pain 30 days	Patient self-reported pain at an numeric rating scale from 0 (no pain) to 10 (worst pain imaginable)	30 days post-operatively
Secondary	Medication intake	Patient self-reported analgesic and antibiotic intake	30 days post-operatively
Secondary	Tooth survival at year 1	Presence of root-filled tooth	1 year after completed treatment
Secondary	Tooth survival at year 4	Presence of root-filled tooth	4 year after completed treatment
Secondary	Complications	Complications not previously described that can be associated with endodontic treatment	30 days and long-term follow-up at year 1 and 4