Effect of Passive Ultrasonic Irrigation on Success of Primary Endodontic Treatment (NCT02632513) | Clinical Trial Compass
CompletedNot Applicable
Effect of Passive Ultrasonic Irrigation on Success of Primary Endodontic Treatment
70 participantsStarted 2014-05
Plain-language summary
The aim of this study was to compare the success after endodontic treatment performed with or without continuous ultrasonic irrigation.
70 Mandibular molars with diagnosis of pulpal necrosis and with periapical radiolucency were randomly assigned into two treatment groups- continuous ultrasonic irrigation (CUI) and syringe irrigation (SI). Standard nonsurgical endodontic treatment was performed on both groups under rubber dam isolation with 0.02 taper ISO stainless steel hand files using step back technique. In both groups, 5 ml of 5.25% sodium hypochlorite was used as irrigant after each instrument. After root canal instrumentation, canals were irrigated with 5 ml of 17% EDTA solution for 1 minute. In SI group, canals were flushed with 15ml of 5.25% sodium hypochlorite using a 27 gauge needle while final irrigant was delivered using a continuous ultrasonic irrigation device in CUI group. An inter-appointment dressing of calcium hydroxide was given and patient was recalled after one week and canals were obturated with the Gutta Percha. Immediate postoperative radiograph was then taken, followed by radiographs at 3, 6, 9 and 12 months.
Who can participate
Age range
18 Years – 45 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:
* • Patient willingness to participate in the study
* Mature permanent mandibular molar requiring primary root canal treatment
* Patient's age greater than 18 years
* There must be radiographic evidence of periapical radiolucency (minimum size ≥ 2.0 × 2.0 mm) and a diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber
Exclusion Criteria:
* • Patients who did not provide authorization for participation in the study
* Positive history of antibiotic use within past one month of the treatment
* Positive history of analgesic intake within the past 24 hours
* Patients who were pregnant, diabetic, immunocompromised, had serious medical illness or required antibiotic premedication
* Patients with pockets ≥4mm or having marginal of furcal bone loss due to periodontitis
* Previously accessed teeth and/or with procedural errors
* Unrestorable tooth, fractured/ perforated roo ts, inflammatory root resorption
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
Periapical Index score
Timeframe: 1 year
Trial details
NCT IDNCT02632513
SponsorPostgraduate Institute of Dental Sciences Rohtak