The Effect of Using Reciprocal Files Alone and with Different Files on Postoperative Pain
NCT ID: NCT06833515
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
130 participants
INTERVENTIONAL
2025-03-15
2026-09-01
Brief Summary
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It will also reveal whether reciprocating files can be used alone or not.
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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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one flare+wave one gold glider+wave one gold
Using 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.
one flare+wave one gold glider+wave one gold
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.
waveone gold glider+waveone gold
Using 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.
wave one gold glider+wave one gold
In this group, only the glide path and final shaping will be performed using reciprocal files, without coronal shaping.
waveone gold
Using 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.
wave one gold
In this group, shaping will be performed using only a reciprocating file, without coronal shaping and glide path preparation.
15K-type stainless-steel hand file
The operator will prepare the glide path using a
* 15K-type stainless-steel hand file with push-pull motion. On sensing resistance, the file was withdrawn, recapitulation will performe with a #10K-type stainless-steel file, and debris will removed by irrigating the canals with 5% NaOCl. The operator repeated this procedure until the
* 15K-file reached the complete working length.
15K-type stainless-steel hand file
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
Interventions
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one flare+wave one gold glider+wave one gold
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 gold
In this group, only the glide path and final shaping will be performed using reciprocal files, without coronal shaping.
wave one gold
In this group, shaping will be performed using only a reciprocating file, without coronal shaping and glide path preparation.
15K-type stainless-steel hand file
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Harran University
OTHER
Responsible Party
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Nezif Celik
assistant professor
Principal Investigators
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tolga han edebal, PhD
Role: STUDY_CHAIR
HARRAN UNİVERSTY
Locations
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Nezif Çelik
Karaköprü, Şanlıurfa, Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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HRÜ-DHF-END-NC-02
Identifier Type: -
Identifier Source: org_study_id
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