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Post Operative PainNCT06833515

The Effect of Using Reciprocal Files Alone and With Different Files on Postoperative Pain

A study testing one flare+wave one gold glider+wave one gold, wave one gold glider+wave one gold and wave one gold in people with Post Operative Pain and Chronic Apical Periodontitis of Pulpal Origin, run by Harran 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

This study aims to investigate the effects of using the Wave One Gold file alone and in combination with different files on postoperative pain in patients with asymptomatic apical periodontitis. The results of the study may provide important insights into the impact of these file systems on postoperative pain. . Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
one flare+wave one gold glider+wave one gold, wave one gold glider+wave one gold and wave one gold
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
168 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Mar 2025to 10 Mar 2026
Phase
Interventional

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult, systemically healthy patients aged18-65years(category:AmericanSocietyof Anesthesiologists class 1.
  • Patients diagnosed with symptomatic reversible pulpitis and having mandibular first and second premolar teeth without percussion pain.
  • Teeth with prolonged response to the coldpulp test (Endo-Frost, Coltene-Whaledent, Allstetten, Switzerland) (teeth where pain persists for a long time after stimulus removal)
  • Teeth with normal periapical appearance(periapical index 2), a single root canal andaroot canal inclination less than 20° on a parallel periapical radiograph
  • Teeth with moderately sharp spontaneous pain (preoperative visual analog scale [VAS] score 4-6)
  • Teeth where number 10 K files can reach and fit the working lenght
  • Patients who were able to understand the informed consent form and pain recording scales used in the study were included

Who cannot join

  • Patients who are pregnant and lactating
  • Patients who received analgesics or anti inflammatory drugs in the last 12 hours and antibiotics for the last 1 month
  • Patients with severe periodontal defect or deep periodontal pocket (probing depth.3 mm)and poor oral hygiene
  • Teeth too broken down, difficult to isolate with rubber dam
  • Teeth without occlusal contact
  • Presence of multiple teeth requiring treatment, a previous treatment history and an open apex
  • Teeth with calcified root canal, root resorption, crown and/or root fracture, multiple root canals, post, and sinus tract were excluded from the study -• VAS pain score of 1 and above

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Nezif Çelik

    Karaköprü, Şanlıurfa, 63300

Other trials in Turkey (Türkiye)

About this study

Official title: Title Effect of Different Root Canal Shaping Protocols on Postoperative Pain in Patients With Asymptomatic Apical Per-iodontitis: A Randomized Clinical Trial

This study aims to investigate the effects of using the Wave One Gold file alone and in combination with different files on postoperative pain in patients with asymptomatic apical periodontitis. The results of the study may provide important insights into the impact of these file systems on postoperative pain. . The main questions it aims to answer are:

It will also reveal whether reciprocating files can be used alone or not.

Read more

Participants will:

Go under treatment with different shaping protocols The researchers will shape using only the Wave One gold file in the first group.

In the second group, they will first perform coronal shaping with the One Flare file and then complete the final shaping with the Wave One Gold file In the third group, coronal shaping will first be performed with the One Flare, followed by working length shaping with the Wave One Gold glider file, and the final shaping will again be completed with the Wave One file. For sham group Using a #10K-type stainless-steel file, the operator will establish the working length 0.5 mm short of the apex indicated by the apex locator and will confirm it on periapical radiograph. The operator will prepare the glide path using a #15K-type stainless-steel hand file with push-pull motion.On sensing resistance, the file will withdraw.

recapitulation was performed with a #10K-type operator then will irrigate the root canals with 2 mL of 5%NaOCl . Then, they will be shaped using WaveOne Gold Glider and WaveOne in reciprocal mode. After the treatment, the patient's pain score will be recorded.

They will Visit the clinic three days later Keep avisual analogue scala of their symptoms and than compare different shaping protocols

Read the detailed description

Randomization The names of systems will write on the papers, the papers will fold, and these papers will placed into a dark box, which cannot be seen from theoutside. Before each treatment, the clinical assistant chose a paper randomly from the dark box and the system written in that paper will applied to the patient.

Treatment Protocol A single operator will performe root canal treatment for all the patients in 2 sessions. The operator will administer local anesthesia with 2 mL of 4 articaine and 1:100,000 epinephrine (Ultracain DS Fort; Aventis _ Ilaç A.S x, Istanbul, Turkey) 10 minute before the procedure. Then, the tooth of interest will isolate using a rubber dam. Caries or coronal restorations will remove completely, and the endodontic access cavity will open using diamond fissure burs(Diatech,Diamant AG, Switzerland) under water-cooled conditions. After negotiating the root canal orifices, the apical patency of the teeth wil checked

The study will be examined wave one gold with/without one flare and wave one gold glider. First, in the first group, the Wave One Gold file will be used as a single-file system according to the manufacturer's usage instructions. In the second group, the One Flare file will be used first, and the final shaping will be done with the Wave One Gold file. In the third group, the One Flare file will be used first, followed by the Wave One Gold glider, and the final shaping will be performed with the Wave One Gold file.

As a rinsing protocol, each file change will be followed by a rinse with 2 mL of using a side-perforated 30 G needle . In the final rinse, 10 mL of 17% EDTA and 10 mL of 2.5% NaOCl will be activated ultrasonically.

Later, patients will be informed about the visual analog scale (VAS). Patients will be called for a check-up three days later. The evaluation scores of the patients and their use of painkillers will be noted.

Statistical analysis A sample size calculation was performed using the G∗Power software (G∗Power 3.1.9.7; Heinrich-Heine Universität, Düsseldorf, Germany) based on a 0.05 type I error, 80% power, and an effect size of 0.25. According to Cohen, the minimum sample size required to detect differences in postoperative pain intensity among 4 study groups at 3 time points would be 36. Since this study was analyzed using non-parametric methods, a decision was made to include 42 patients (36 * 1.15 = 42) as suggested by Lehmann, with 42 patients allocated to each group; this number was sufficient to ensure statistical significance. In comparing multiple group contrasts and repeated measurements, ANOVA test will be used. The Shapiro-Wilk test will be employed to check for normal distribution of the data.

Being tested
one flare+wave one gold glider+wave one gold, wave one gold glider+wave one gold, wave one gold, 15K-type stainless-steel hand file
Keywords
rotary, reciproc, mode, pain, periodontitis
Medical subject headings
Pain, Postoperative, Pain, Periodontitis

What participants receive

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

  • one flare+wave one gold glider+wave one goldOther

    In this clinical study, the teeth will first undergo coronal shaping with the One Flare file. Then, the glide path and final shaping will be performed in reciprocal mode with reciprocal files.

  • wave one gold glider+wave one goldOther

    In this group, only the glide path and final shaping will be performed using reciprocal files, without coronal shaping.

  • wave one goldOther

    In this group, shaping will be performed using only a reciprocating file, without coronal shaping and glide path preparation.

  • 15K-type stainless-steel hand fileOther

    The operator prepared the glide path using a #15K-type stainless-steel hand file with push-pull motion. On sensing resistance, the file was withdrawn, recapitulation was performed with a #10K-type stainless-steel file, and debris was removed by irrigating the canals with 5% NaOCl. The operator repeated this procedure until the #15K-file reached the complete working length

Study groups in NCT06833515
Study groupRoleWhat they receive
one flare+wave one gold glider+wave one goldActive comparatorUsing a #10K-type stainless-steel file, the operator will establish the working length 0.5 mm short of the apex indicated by the Root ZX Mini apex locator and will confirm it on periapical radiograph. The operator then will irrigate the root canals with 2 mL of 5%NaOCl . Teeth in this group will first be shaped in rotational mode using One Flare. Then, they will be shaped using WaveOne Gold Glider and WaveOne in reciprocal mode. After the treatment, the patient's pain score will be recorded.
Receives: Other: one flare+wave one gold glider+wave one gold
waveone gold glider+waveone goldActive comparatorUsing a #10K-type stainless-steel file, the operator will establish the working length 0.5 mm short of the apex indicated by the Root ZX Mini apex locator and will confirm it on periapical radiograph. The operator then will irrigate the root canals with 2 mL of 5%NaOCl. this group teeth will be operated using reciprocal motion with waveone gold glider and waveone gold. After the treatment, the patient's pain score will be recorded.
Receives: Other: wave one gold glider+wave one gold
waveone goldActive comparatorUsing a #10K-type stainless-steel file, the operator will establish the working length 0.5 mm short of the apex indicated by the Root ZX Mini apex locator and will confirm it on periapical radiograph. The operator then will irrigate the root canals with 2 mL of 5%NaOCl. this group teeth will be operated using reciprocal motion with wave one gold. After the treatment, the patient's pain score will be recorded.
Receives: Other: wave one gold
15K-type stainless-steel hand filePlacebo comparatorCanal preparation was performed using stainless steel manual K-files with the step-back technique. Apical preparation was enlarged up to a #25 K-file at the working length. Subsequently, using larger files, progressive coronal enlargement was performed according to the step-back approach to achieve appropriate canal taper.
Receives: Other: 15K-type stainless-steel hand file

What is being measured

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

  1. visual analoge scala

    it contains 5 different images correlated with severity of pain with 10 numeric levels of pain. Minimum value of pain is 1 while the highest value is 10. 10 is a worse value of pain than 1.

    Measured: 24-48-72 hours

Timeline

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

  1. First posted18 Feb 2025
  2. Study start15 Mar 2025
  3. Primary completion1 Mar 2026
  4. Study completion10 Mar 2026

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
experimental groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06833515
Sponsor's protocol ID
HRÜ-DHF-END-NC-02
Status last verified
Mar 2026
First submitted
13 Feb 2025
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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