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Postoperative PainPainNCT04726670

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

An observational study of Postoperative Pain, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Pain
What is being tested?
Evaluation of postoperative pain
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2020to 15 Nov 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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).

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Yildirim BEYAZIT UNIVERSITY

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of EDDY and Manual Dynamic Activation Techniques on Postoperative Pain in Retreatment: a Randomized Controlled Trial

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.

Being tested
Evaluation of postoperative pain
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluation of postoperative painOther

    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.

Study groups in NCT04726670
Study groupRoleWhat they receive
A Comparison of Pain LevelsA Comparison of Pain Levels at different time intervals according to the Irrigation Activation Protocols
Receives: Other: Evaluation of postoperative pain
The evaluation of postoperative pain (Mean Rank) within the group according to time periodsThe evaluation of postoperative pain (Mean Rank) within the group according to time periods
Receives: Other: Evaluation of postoperative pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of EDDY and manual dynamic activation techniques on postoperative pain in retreatment: a randomized controlled trial

    Evaluation of postoperative pain

    Measured: 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2021
  2. Study start1 Jan 2020
  3. Primary completion1 Oct 2020
  4. Study completion15 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04726670
Sponsor's protocol ID
2019-549
Acronym
Pain
Status last verified
Jan 2021
First submitted
23 Jan 2021
Last updated
27 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pain, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of EDDY and manual dynamic activation techniques on postoperative pain in retreatment: a randomized controlled trial (time frame: 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04726670, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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