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NCT07150585
Effects of Irrigation Activation Systems on Postoperative Pain and Lesion Healing in Single-Visit Retreatment
NA trial testing Ultrasonic Activation Group in Retreatment in 75 participants. Participants enrolled and being followed up; not accepting new ones.
1 June 2025
Quick facts
| Lead sponsor | Ege University |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 1 August 2024 |
| Primary completion | 1 June 2025 |
| Estimated completion | 1 June 2027 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Ultrasonic Activation Group
- Sonic Activation Group
- Laser Activation Group
Conditions studied
- Retreatment — all drugs for Retreatment →
- Asymptomatic Apical Periodontitis — all drugs for Asymptomatic Apical Periodontitis →
Sponsor
Ege University
Who can join
Adults 18 to 65, any sex, with Retreatment or Asymptomatic Apical Periodontitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this superiority randomized clinical trial with a parallel design, 75 asymptomatic maxillary anterior teeth with 2-5 mm periapical lesions and a history of primary root canal treatment (PRCT) at least four years earlier were included. Patients were randomly assigned, using a randomization sequence generated on www.random.org, and divided into three groups. In all patients, existing canal fillings were removed using Remover rotary file (Coltene, MicroMega) and hand files. Working lengths were determined with an apex locator and canals reshaped using the step-back technique. For the final irrigation, side-vented needles were positioned 2 mm short of the working length. Activation was performed with Ultra X (Eighteeth) in the ultrasonic group, EDDY (VDW) in the sonic group, and an Er:YAG laser (LightWalker, Fotona) in SWEEPS mode (2940 nm, 5 μs, 20 mJ, 15 Hz) in the laser group. In all groups, each irrigant (EDTA followed by NaOCl) was activated in three cycles of 20 seconds. All canals were obturated with gutta-percha and a bioceramic sealer, and restored with composite. Pain levels were recorded using the Visual Analog Scale (VAS) 0, 6, 12, 24, 48, and 72 hours, and on day 7. The completed forms were collected by another independent investigator blinded to the group assignments. At the end of the treatment, periapical radiographs were obtained and recorded from all patients. Patients whose treatment was completed will be recalled at the 6th, 12th, and 24th months for follow-up periapical radiographs, and the comparison of healing among the groups will be evaluated as a secondary outcome based on changes in the PAI index.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07150585 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ege University
- Last refreshed: 5 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07150585.
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