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).
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
- Conditions the study is for
- Post Operative Pain, Chronic Apical Periodontitis of Pulpal Origin
- 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
- 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 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.
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 group | Role | What they receive |
|---|---|---|
| one flare+wave one gold glider+wave one gold | Active comparator | 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. Receives: Other: one flare+wave one gold glider+wave one gold |
| waveone gold glider+waveone gold | Active comparator | 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. Receives: Other: wave one gold glider+wave one gold |
| waveone gold | Active comparator | 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. Receives: Other: wave one gold |
| 15K-type stainless-steel hand file | Placebo comparator | Canal 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.
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.
- First posted18 Feb 2025
- Study start15 Mar 2025
- Primary completion1 Mar 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezif Celik, Harran University
- Investigators
- tolga han edebal, PhD, Study chair, HARRAN UNİVERSTY
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title Effect of Different Root Canal Shaping Protocols on Postoperative Pain in Patients With Asymptomatic Apical Per-iodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06833515
- Acronym / sponsor ID
- HRÜ-DHF-END-NC-02
- Keywords
- rotary, reciproc, mode, pain, periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- experimental groups
| Arm | Type | Receives |
|---|---|---|
| one flare+wave one gold glider+wave one gold | Active comparator | Other: one flare+wave one gold glider+wave one goldUsing 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. |
| waveone gold glider+waveone gold | Active comparator | Other: wave one gold glider+wave one goldUsing 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. |
| waveone gold | Active comparator | Other: wave one goldUsing 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. |
| 15K-type stainless-steel hand file | Placebo comparator | Other: 15K-type stainless-steel hand fileCanal 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| one flare+wave one gold glider+wave one goldIn 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. | Other | one flare+wave one gold glider+wave one gold |
| wave one gold glider+wave one goldIn this group, only the glide path and final shaping will be performed using reciprocal files, without coronal shaping. | Other | waveone gold glider+waveone gold |
| wave one goldIn this group, shaping will be performed using only a reciprocating file, without coronal shaping and glide path preparation. | Other | waveone gold |
| 15K-type stainless-steel hand fileThe 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 | Other | 15K-type stainless-steel hand file |
Primary outcome
visual analoge scala
Time frame: 24-48-72 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
tolga han edebal, PhD study chair
HARRAN UNİVERSTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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).
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 7 inclusion and 7 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 12 Mar 2026. 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. Some participants in this study may receive a placebo. 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?
visual analoge scala (time frame: 24-48-72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026.