One vs Two Visits Root Canal Treatments in Infected Teeth

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Apical Periodontitis; Tooth Loss; Dental Pulp Necrosis
• Intervention / Treatment: Procedure: 1 visit root canal treatment (endodontics); Procedure: 2 visits root canal treatment (endodontics)

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annika Björkner, PhD; Phone Number: +46-(0)40-6658532; Email: annika.bjorkner@mau.se
• Study Contact Backup: Name: Catherine Benavente Hansson, DDS; Phone Number: +46-(0)665 87 95; Email: catherine.benavente-hansson@mau.se

Study Locations

• Sweden
  • Kalmar, Sweden
    • Not yet recruiting
    • Folktandvården Region Kalmar
    • Contact: Elena Shmarina
  • Luleå, Sweden
    • Recruiting
    • Smile Tandvård
    • Contact: Anna Gatu; Email: anna.gatu@smile.se
    • Contact: Lars Armbäck, DDS; Email: Lars.armback@smile.se
  • Malmö, Sweden
    • Not yet recruiting
    • Aragón Dental
    • Contact: Veronica Aragón, DDS
  • Malmö, Sweden
    • Not yet recruiting
    • Oris Dental
    • Contact: Catherine Benavente Hansson, DDS
  • Varberg, Sweden
    • Recruiting
    • Folktandvården Region Halland
    • Contact: Maria Wattsgård; Phone Number: +46-(0)340-48 23 00; Email: Maria.Wattsgard@regionhalland.se
  • Kronoberg
    • Växjö, Kronoberg, Sweden, 352 31
      • Recruiting
      • Folktandvården Region Kronoberg
      • Contact: Veronica Asp Lockby
  • Norrbotten
    • Luleå, Norrbotten, Sweden, 97128
      • Recruiting
      • Folktandvården Region Norrbotten
      • Contact: Fernando Mota de Almeida, PhD; Phone Number: 0046-920-71975; Email: fernando.mota-de-almeida@norrbotten.se
      • Contact: Elin Lundgren, DDS; Email: elin.s.lundgren@norrbotten.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 visit endodontics; Root canal treatment is performed in one visit.	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.
Active Comparator: 2 visits endodontics; Root canal treatment is performed in two visits.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periapical health at year 1	Assessment of apical radio-anatomical structures by two independent and blinded observers	One year after completed treatment
Periapical health at year 4	Assessment of apical radio-anatomical structures by two independent and blinded observers	Four years after completed treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Medication intake	Patient self-reported analgesic and antibiotic intake	30 days post-operatively
Tooth survival at year 1	Presence of root-filled tooth	1 year after completed treatment
Tooth survival at year 4	Presence of root-filled tooth	4 year after completed treatment
Complications	Complications not previously described that can be associated with endodontic treatment	30 days and long-term follow-up at year 1 and 4

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2020
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Endodontics; General Dental Practice; Single Visit; Multiple Visits; Infection Barrier
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Dental Pulp Diseases; Periapical Diseases; Periodontitis; Necrosis; Periapical Periodontitis; Tooth Loss; Dental Pulp Necrosis
• Other Study ID Numbers: EPN 2020-00207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No