An observational study in Postoperative Pain, sponsored by Ankara Yildirim Beyazıt University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-27.
Sponsored by Ankara Yildirim Beyazıt University · Observational
The aim of the study was to evaluate the effectiveness of EDDY and manual dynamic activation (MDA) techniques on postoperative pain (PP) associated in retreatment. Ninety patients scheduled for retreatment were treated at one visit. After the single visit retreatment procedure, the patients were divided into two groups (n = 45) on the basis of the need for additional irrigation activation procedures (EDDY and MDA). The patients' post-treatment pain levels were asked to rate the intensity of their pain on a 10-point numerical rating scale (NRS) at 12th, 24th, 48th, and 72th hours and 7 days.
The sample size was based on pilot study data that indicated that 38 patients would be sufficient for each group (type I alpha error = 5%, effect size = 0.7, power = 80%). To compensate for possible dropouts during the treatment and/or follow-up periods, 45 patients were assigned to each group.The study protocol was approved by the Ankara Yıldırım Beyazıt University Ethical Board of Clinical Trials and Non-interventional Research (2019-549).The inclusion criteria were as follows:
The exclusion criteria were as follows:
The gutta-percha and sealer were removed with hand files and ProTaper retreatment (Dentsply Maillefer) files. No solvent was used. The working length was calculated with a ProPex Pixi apex locater (Dentsply Maillefer). Periapical radiography allowed for the calculation of the working length and confirmation of the removal of the previous canal filling. Root canals were enlarged to be ProTaper Universal F3 (30/0.9). A lubricant (Glyde File Prep, Dentsply DeTrey, GmbH, Konstanz, Germany) was used between each file to prevent the rotary files from getting stuck in the root canal. A total of 20 mL 2.5% sodium hypochlorite (NaOCl) irrigation solution (Werax, Izmir, Turkey) was used for each treatment. For all teeth, the final irrigation was performed with 5 mL 17% ethylenediaminetetraacetic acid (EDTA) solution (Werax, Izmir, Turkey) for 1 minute. After the retreatment procedure, the patients were divided into two groups on the basis of the additional irrigation activation procedures with 6 mL 2.5% NaOCl (n = 45). Information on which irrigation activation methods to use was not given to the patient.
First group (manual dynamic activation): A final rinse with 6 mL 2.5% NaOCl was done performed after shaping, using a ProTaper Universal F3 (Dentsply, Maillefer, Ballaigues, Switzerland) gutta-percha up and down movements to as 1 mm short from the working length for 1 minute.
Second group (EDDY): A 28 mm long polyamide tip with 25.04 taper was adapted to TA-200 (Micron, Tokyo, Japan) and operated at 6,000 Hz, the maximum speed setting. It was placed in the canal 2 mm shorter than the working length. Next, 6 mL 2.5% NaOCl was administered to the canal in three 20-second activation-nonactivation cycles (2 ml/20 seconds).
The root canals were dried with paper points (Dentsply, Sirona). The working length was reached with ProTaper Universal F3 gutta-percha (Dentsply, Sirona), and tug-back was taken. The gutta-percha was covered with a sealer (AH Plus; Dentsply, Sirona), and root canal fillings were performed with a single-cone technique. After the completion of the root canal filling procedures, the residual materials were removed with a heat source. A resin composite (3M, ESPE) was used for the coronal restorations. Occlusal reduction was performed on all the teeth included in the study. No antibiotics or analgesics were prescribed.
Patient questionnaire The postoperative follow-up and evaluation of the cases were performed by a researcher who had no knowledge of the study group. A 10-point numerical rating scale (NRS) was introduced to the patients, and they were asked to rate their post-treatment pain by telephone after 12, 24, 48, and 72 hours. The antibiotics and analgesics were questioned. The patients were called for clinical examination 1 week later. Palpation and percussion sensitivity in the treated teeth was determined on the basis of the patients' perceptions of pain. All percussion tests were performed by the same operator to ensure standardization. The measurement values were based on the 10-point NRS. The pain scores were placed into the following four categories: 0 = none, 1-3 = mild, 4-6 = moderate, and 7-10 = severe.
5,227 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 90 is close to the median of 100 across 622 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Ankara Yildirim Beyazıt University is the lead sponsor of 238 studies on the registry; 55 are open to participants now.
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Patients referred to the endodontic clinic for retreatment were asked to complete a questionnaire to provide pre-treatment clinical conditions and demographic data. participant voluntary consent form was obtained from each patient. Ninety patients were numerically coded in computer environment by someone who was not included in the study for randomization (www.random.org).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- 1- Healthy individuals aged 18 to 40 years. 2- Devital mandibular premolar teeth with asymptomatic periapical lesions. 3- Teeth with initial root canals filled 2-4 mm short of the apex. 4- Premolar teeth with periapical radiolucency (PAI 3-4) [12] detected by radiographic examination.
5- Coronal restoration. 6- Teeth on which root canal treatment had been performed in the researcher's hospital at least 4 years prior to the study.
Exclusion Criteria:
1- The use of drugs, such as analgesics, anti-inflammatories, and antibiotics, for pain and infection control in the previous 12 hours.
2- A history of susceptibility or adverse reactions to any drugs or materials used in the study.
3- Teeth with open apexes and resorption. 4- Teeth with post-core restoration. 5- Vertical root fractures and teeth on which surgery had been performed. 6- Pregnancy and breastfeeding.
A Comparison of Pain Levels at different time intervals according to the Irrigation Activation Protocols
Other: Evaluation of postoperative pain
The evaluation of postoperative pain (Mean Rank) within the group according to time periods
Other: Evaluation of postoperative pain
A participant voluntary consent form was obtained from each patient. Ninety patients were numerically coded in computer environment by someone who was not included in the study for randomization (www.random.org). A single clinician performed retreatment on each of the 90 teeth during a single visit.
Effect of EDDY and manual dynamic activation techniques on postoperative pain in retreatment: a randomized controlled trial
Evaluation of postoperative pain
Time frame: 1.5 years
Plan to share: Undecided
Ran from Jan 2020 to primary completion in Oct 2020, 9 months.
Of 347 non-industry observational studies under Pain, Postoperative, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's 9 months is below that.
Counting every sponsor, half of 352 studies reached it within 14 months; a quarter within 6 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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