Comparison Between RCT in Single and Two Visits, With and Without Intracanal Dressing, in Apical … (NCT05256667) | Clinical Trial Compass
UnknownPhase 2/3
Comparison Between RCT in Single and Two Visits, With and Without Intracanal Dressing, in Apical Repair
Brazil210 participantsStarted 2021-10-02
Plain-language summary
This is a randomized, prospective, double-blind, controlled clinical trial designed to evaluate 3 distinct clinical approaches used during endodontic therapy: Group 1- Root canal treatment in single visit (RCT-SV); Group 2- Root canal treatment in two visits with intracanal dressing (RCT-TVWD); Group 3- Root canal treatment in two visits without intracanal dressing (RCT-TVWOD). A total of 210 adult patients ages 18 to 60 years, with at least one tooth diagnosed with asymptomatic apical periodontitis and periradicular lesion will be randomized and will undergo one of the types of clinical approaches during endodontic therapy. Patients' postoperative pain levels will also be recorded in periods of 24, 48, 72 hours and 7 days. Subsequently, clinical findings and long-term follow-up evaluations, with periradicular repair will be performed by periapical radiograph and computed tomography (cone-beam) at 6th, 12th and 24th months.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Patients diagnosed with apical periodontitis in lower molar teeth (first or second molars), the periradicular lesion with a diameter between 1 and 5mm analyzed through the real 1:1 tomographic scale
* Asymptomatic patients
* Patients who spontaneously agree and sign the informed consent form
* Patients in good health
* Patients who are not taking antibiotics and anti-inflammatory drugs
Exclusion criteria:
* Patients with systemic diseases (diabetes, transplants, heart disease, liver failure and kidney failure)
* Immunodepressed patients
* Teeth with extensive coronary destruction that makes direct restoration with composite resin unfeasible
* Calcified teeth
* Teeth with incomplete root formation
* Teeth with persistent exudation
* Teeth with anatomical complexities that prevent endodontic treatment in a single visit
* Teeth recommended for endodontic retreatment
* Teeth with advanced periodontal pocket
* Teeth in which foraminal patency is not obtained
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Healing of periradicular lesions by radiographic findings according to periapical Index (PAI)
Timeframe: Long-term follow-up evaluation in 24 months.