Effectiveness of Laser-activated Photoacoustic Flow in One-visit Revision of Teeth With Apical Pe… (NCT07387809) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effectiveness of Laser-activated Photoacoustic Flow in One-visit Revision of Teeth With Apical Periodontitis
Croatia60 participantsStarted 2024-01-15
Plain-language summary
The main objective of the clinical randomized study is to examine the effectiveness laser-activated irrigation (LAI) on the removal of intracanal microorganisms and the healing of an inflammatory periapical lesion of a tooth after a one-visit revision of teeth with apical periodontitis.
The main questions are:
1. Does LAI reduces the occurrence of postoperative pain, compared with sonic-activated irrigation?
2. Is antimicrobial efficacy of LAI greater than the antimicrobial efficacy of sonic-activated irrigation?
3. Is periapical lesion healing after LAI application better than after sonic-activated irrigation?
Researcher will compare LAI and sonic-activated irrigation in patients with signs and symptoms of chronic apical periodontitis requiring revision. Participants will be assigned to two experimental groups depending on the final root canal disinfection protocol. Postoperative pain will be assessed via a questionnaire that participants will receive after the treatment and which they will complete over a period of seven days. Microbiological samples will be collected from the root canal and real-time PCR analysis will be performed to evaluate antimicrobial efficacy. Assessment of periapical lesion healing will be performed by comparing CBCT scans obtained before the treatment and one year after.
Who can participate
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:
* teeth tender to percussion, palpation
* teeth that have a sinus tract and swelling
* a chronic periapical lesion greater than 5 mm in diameter based on the initial X-ray
* previous endodontic treatment and root canal filling that is inadequate according to clinical criteria (filling, overfilling, non-homogeneous root canal filling, unfilled root canals)
Exclusion Criteria:
* immunocompromised patients
* pregnant women
* teeth with a periodontal pocket depth greater than 3 mm
* teeth with signs and symptoms of vertical fracture
* teeth that cannot be restored or prosthetically provided after endodontic treatment
* use of antibiotic therapy within the last month
* diagnosis of acute apical abscess
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
Postoperative pain
Timeframe: From day 1 after treatment to 7 days postoperatively