Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04605445

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

Led by Malmö University · Updated on 2024-12-16

1000

Participants Needed

7

Research Sites

208 weeks

Total Duration

On this page

Sponsors

M

Malmö University

Lead Sponsor

N

Norrbottens County Council

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are comparing one-visit versus two-visit root canal treatments for infected (necrotic) teeth in general dental practice. The study aims to evaluate the outcomes one and four years after treatment, focusing on periapical health, root filling quality, and complication rates. A pilot study will first identify and address any protocol issues before the main multicenter trial across several clinics in Sweden begins. Patients will be randomly assigned to receive either a root canal treatment completed in one visit or in two visits spaced at least one week apart. Both treatment methods follow standard clinical practices without rigid protocols. After treatment, patients will have a phone call 5-7 days later, a control visit at one month, and clinical evaluations at one and four years including intra-oral radiographs reviewed by independent observers. During the study, participants will undergo regular assessments of post-operative pain, medication use, tooth survival, and any complications. Follow-up includes clinical exams and radiographic checks to determine treatment success based on clinical and radiographic normalcy. The study plans to recruit about 1000 patients to ensure statistically meaningful results, with monitoring continuing up to four years after treatment completion.

CONDITIONS

Brief Title

One Vs Two Visits Root Canal Treatments in Infected Teeth

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient older than 17 years
  • Permanent tooth requiring root canal treatment, excluding third molars
  • Necrotic tooth with or without clinical or radiological signs of apical periodontitis
  • Orthograde endodontic treatment planned for the affected tooth
Not Eligible

You will not qualify if you...

  • Severe general disease or health conditions requiring special consideration for endodontic treatment
  • Systemic involvement such as fever
  • Presence of swelling inside or outside the mouth
  • Previously root canal treated tooth
  • Confirmed or suspected root fracture
  • Tooth trauma within the last 6 months
  • Marginal bone loss exceeding one-third of the root length
  • Root resorption
  • Tooth cannot be restored
  • Endodontic treatment not feasible due to inability to use rubber dam
  • Follow-up at the clinic beyond one year not feasible

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 to 2 weeks depending on treatment arm

Participants receive root canal treatment either in one visit or in two visits at least one week apart, involving cleaning, shaping, and filling procedures as part of routine dental care.

1 or 2 visits (in-person) depending on assigned treatment

Follow-up

Duration - Up to 4 years after completed treatment

Participants are monitored for post-operative pain, medication intake, complications, and tooth survival up to 4 years after treatment completion.

Visits at 5-7 days, 30 days, 1 year, and 4 years post-treatment

Trial Site Locations

Total: 7 locations

1

Folktandvården Region Kronoberg

Vaxjo, Kronoberg County, Sweden, 352 31

Actively Recruiting

2

Folktandvården Region Norrbotten

Luleå, Norrbotten County, Sweden, 97128

Actively Recruiting

3

Folktandvården Region Kalmar

Kalmar, Sweden

Not Yet Recruiting

4

Smile Tandvård

Luleå, Sweden

Actively Recruiting

5

Aragón Dental

Malmö, Sweden

Not Yet Recruiting

6

Oris Dental

Malmö, Sweden

Not Yet Recruiting

7

Folktandvården Region Halland

Varberg, Sweden

Actively Recruiting

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Research Team

A

Annika Björkner, PhD

C

Catherine Benavente Hansson, DDS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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