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CompletedNCT04726670PainUpdated Jan 27, 2021

Effect of EDDY and Manual Dynamic Activation Techniques on Postoperative Pain in Retreatment

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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.

Read the detailed description

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:

  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.

The exclusion criteria were as follows:

  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 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. A 27-gauge dental injector (Set Inject; Set Medical Instruments, Istanbul, Turkey) was used to anesthetize the patients with a solution of 40 mg Articain and 0.006 mg/mL epinephrine (Ultracain DS Forte; Aventis, Istanbul, Turkey). Old restorations and caries were removed, and on the basis of the straight-line principle, round diamond burs were used to create access cavities under rubber dam isolation. All subsequent treatment procedures were performed under rubber dam isolation, and 3.5× (Zumax Sle Loupe) magnification was used. When necessary, the cervical margin was elevated with composite resin to ensure the continuity of the isolation.

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.

02

Conditions studied

  • Postoperative Pain

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03

In context

Pain, Postoperative

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 →

Lead sponsor

Ankara Yildirim Beyazıt University is the lead sponsor of 238 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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.

Inclusion criteria

- 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

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No

Groups and cohorts

  • A Comparison of Pain Levels

    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

    The evaluation of postoperative pain (Mean Rank) within the group according to time periods

    Other: Evaluation of postoperative pain

Interventions

  • OtherEvaluation 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.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Ankara Yildirim BEYAZIT UNIVERSITY
    Ankara, Turkey (Türkiye)
08

References and documents

Publications

  • Gundogar M, Sezgin GP, Kaplan SS, Ozyurek H, Uslu G, Ozyurek T. Postoperative pain after different irrigation activation techniques: a randomized, clinical trial. Odontology. 2021 Apr;109(2):385-392. doi: 10.1007/s10266-020-00553-5. Epub 2020 Sep 11. PubMed 32915346 ↗
  • Ince-Yusufoglu S, Keskin NB, Uslu G, Helvacioglu-Yigit D. Effect of EDDY and manual dynamic activation techniques on postoperative pain in non-surgical retreatment: a randomized controlled trial. BMC Oral Health. 2023 Jan 3;23(1):3. doi: 10.1186/s12903-022-02702-4. PubMed 36597145 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Jan 23, 2021
First posted
Jan 27, 2021
StartActual
Jan 1, 2020
Primary completionActual
Oct 1, 2020
CompletionActual
Nov 15, 2020
Last update
Jan 27, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04726670
Responsible party
Sponsor
First posted
Jan 27, 2021
Start date
Jan 1, 2020
Primary completion
Oct 1, 2020
Completion
Nov 15, 2020
Last update
Jan 27, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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