Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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