Post-operative PainEndodonticsNCT06357481
Evaluation of Postoperative Pain After Single Visit Retreatment of Symptomatic and Asymptomatic Teeth
A study testing Endodontic Retreatment in people with Post-operative Pain and Retreatment, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Introduction: The aim of this study comparing the post operative pain after the retreatment of asymptomatic and symptomatic teeth that during single visit treatment with rotary and reciprocal nickel titanium files. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Retreatment, Symptomatic Periapical Periodontitis
- What is being tested?
- Endodontic Retreatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jan 2023to 28 Jan 2024
- 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 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Symptomatic Apical Periodontitis
- Asymptomatic Apical Periodontitis
- Adult patients between 18-67 years aged
Who cannot join
- Patient under 18 years old
- Complicating systemic disease
- Allergies to local anesthetic agents
- Acute apical abscesses
- Periodontal pockets deeper than 5 mm or more mobilty than level 1
- Bruxist and teeth-grinding patient
Show all 11Show fewer
- Pregnant women
- Presence of external root resorption
- Root fracture
- Root perforation
- Calcified root canals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Postoperative Pain After Single Visit Retreatment of Symptomatic and Asymptomatic Teeth With Minimal Invasive Rotary and Reciprocal Nickel Titanium Files: A Randomized Clinical Trial
Introduction: The aim of this study comparing the post operative pain after the retreatment of asymptomatic and symptomatic teeth that during single visit treatment with rotary and reciprocal nickel titanium files.
Methods: One hundred and forty one patients scheduled for non-surgical endodontic retreatment were included for evaluation. Eighty five patients who needed endodontic retreatment were assingned to 2 groups according to semptomatic or asemptomatic teeth and 4 subgroups with rotary and resiprocal files. Endodontic filling material was removed with One Flare and MicroMega REMOVER files in the retreatment kit. Patients then recorded their postoperative pain on a VAS scale at 24h, 48h, 72h, 7 days and 14 days post-treatment. Results were analyzed using the Shapiro-Wilk, Mann-Whitney U, Kruskal-Wallis, Dunn-Bonferroni and Pearson Chi-square tests.
Read the detailed description
Retreatment is the procedure performed to regain healthy periapical tissues that the teeth have undergone root canal treatment are re-infected due to apical or coronal leakage, or after an inadequate root canal treatment. When primary root canal treatment fails, the first treatment option is non-surgical retreatment to eliminate the infection. In general, the reported success rate of retreatment ranges from 62% to 91%.
This randomized clinical study's primary goal is to evaluate the postoperative pain following a single visit of root canal retreatment for asymptomatic and symptomatic mandibular premolars using reciprocal and rotary file systems. Therefore, this study aims to compare the effect of one curve mini (rotary file system) and one reci (resiprocal file system) nickel-titanium file systems on postoperative pain after non surgical endodontic retreatment within symptomatic and asymptomatic teeth.
- Conditions
- Post-operative Pain, Retreatment, Symptomatic Periapical Periodontitis, Endodontic Disease, Asymptomatic Periapical Periodontitis
- Being tested
- Endodontic Retreatment
- Keywords
- Post-operative pain, Minimal invasive files, Single visit, Retreatment, Remover files
- Medical subject headings
- Pain, Postoperative, Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodontic RetreatmentProcedure or surgery
A single operator procedured in one visit of non-surgical endodontic retreatment. Teeth were anesthetized using articaine hydrochloride with epinephrine 1:200,000 for mandibulary premolar teeth with one root canal. Each tooth was isolated with a rubber dam and then coronal restorations and caries were removed using sterile high-speed burs under water cooling. After preperation of the cavity access and localization of the canal orifice, all microorganisms that may have entered the root canal system are eliminated by removing the old canal filling with the One Flare and MicroMega REMOVER files in the MicroMega retreatment kit.
| Study group | Role | What they receive |
|---|---|---|
| MICRO MEGA ONE RECI FILES in Group 1 | Experimental | During the non-surgical retreatments, the rotary file systems used in our treatment consist of One Reci system 25.04, 25.06, 35.04, and 45.04 files in symptomatic teeth. Receives: Procedure: Endodontic Retreatment |
| MICRO MEGA ONE CURVE MINI FILES in Group 2 | Experimental | During the non-surgical retreatments, the rotary file systems used in our treatment consist of One Curve mini system 25.04, 25.06, 35.04, and 45.04 files in symptomatic teeth. Receives: Procedure: Endodontic Retreatment |
| MICRO MEGA ONE RECI FILES in Group 3 | Experimental | During the non-surgical retreatments, the rotary file systems used in our treatment consist of One Reci system 25.04, 25.06, 35.04, and 45.04 files in asymptomatic teeth. Receives: Procedure: Endodontic Retreatment |
| MICRO MEGA ONE CURVE MINI FILES in Group 4 | Experimental | During the non-surgical retreatments, the rotary file systems used in our treatment consist of One Curve mini system 25.04, 25.06, 35.04, and 45.04 files in asymptomatic teeth. Receives: Procedure: Endodontic Retreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
After repeated root canal treatments, postoperative pain is frequent. The response to pain varies depending on the situation and perception of pain is not always continuous. The pain was evaluated with a visual analog scale (VAS) (0: no pain, 1-2: discomfort, 3-4: mild, 5: moderate, 6-7: severe, 8-9: very severe, 10: worst pain possible).
Measured: Day 1, Day 2, Day 3, Day 7 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start26 Jan 2023
- Primary completion30 Jan 2023
- Study completion28 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Eighty patients who needed endodontic retreatment were assingned to 2 groups according to symptomatic or asymptomatic teeth and 4 subgroups with rotary and resiprocal files.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huseyin Gurkan Gunec, Asst Prof, Study director, Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357481
- Sponsor's protocol ID
- SaglikBilimleriU-22-122
- Acronym
- Endodontics
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only after the results of the study are published in one of the international journals, they can be made available for the benefit of researchers, while any other data will not be shared.
Publications
Nagendrababu V, Duncan HF, Bjorndal L, Kvist T, Priya E, Jayaraman J, Pulikkotil SJ, Dummer PMH. PRIRATE 2020 guidelines for reporting randomized trials in Endodontics: explanation and elaboration. Int Endod J. 2020 Jun;53(6):774-803. doi: 10.1111/iej.13304. Epub 2020 May 9.
PubMed 32266988Gunec HG, Pehlivan B, Topbas C, Kul AK, Sirin DA. Postoperative Pain Following Single-Visit Nonsurgical Retreatment Using Minimally Invasive Rotary vs. Reciprocating Nickel-Titanium File Systems: A Two-Arm Parallel Randomized Clinical Trial. Pain Res Manag. 2025 Sep 8;2025:6826535. doi: 10.1155/prm/6826535. eCollection 2025.
PubMed 40958962
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Pain After Single Visit Retreatment of Symptomatic and Asymptomatic Teeth With Minimal Invasive Rotary and Reciprocal Nickel Titanium Files: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06357481
- Acronym / sponsor ID
- Endodontics / SaglikBilimleriU-22-122
- Conditions
- Post-operative Pain, Retreatment, Symptomatic Periapical Periodontitis, Endodontic Disease, Asymptomatic Periapical Periodontitis
- Keywords
- Post-operative pain, Minimal invasive files, Single visit, Retreatment, Remover files
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 28 Jan 2024 (actual)
- First posted
- 10 Apr 2024 (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.
Introduction: The aim of this study comparing the post operative pain after the retreatment of asymptomatic and symptomatic teeth that during single visit treatment with rotary and reciprocal nickel titanium files.
Methods: One hundred and forty one patients scheduled for non-surgical endodontic retreatment were included for evaluation. Eighty five patients who needed endodontic retreatment were assingned to 2 groups according to semptomatic or asemptomatic teeth and 4 subgroups with rotary and resiprocal files. Endodontic filling material was removed with One Flare and MicroMega REMOVER files in the retreatment kit. Patients then recorded their postoperative pain on a VAS scale at 24h, 48h, 72h, 7 days and 14 days post-treatment. Results were analyzed using the Shapiro-Wilk, Mann-Whitney U, Kruskal-Wallis, Dunn-Bonferroni and Pearson Chi-square tests.
Detailed description
Retreatment is the procedure performed to regain healthy periapical tissues that the teeth have undergone root canal treatment are re-infected due to apical or coronal leakage, or after an inadequate root canal treatment. When primary root canal treatment fails, the first treatment option is non-surgical retreatment to eliminate the infection. In general, the reported success rate of retreatment ranges from 62% to 91%.
This randomized clinical study's primary goal is to evaluate the postoperative pain following a single visit of root canal retreatment for asymptomatic and symptomatic mandibular premolars using reciprocal and rotary file systems. Therefore, this study aims to compare the effect of one curve mini (rotary file system) and one reci (resiprocal file system) nickel-titanium file systems on postoperative pain after non surgical endodontic retreatment within symptomatic and asymptomatic teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Eighty patients who needed endodontic retreatment were assingned to 2 groups according to symptomatic or asymptomatic teeth and 4 subgroups with rotary and resiprocal files.
| Arm | Type | Receives |
|---|---|---|
| MICRO MEGA ONE RECI FILES in Group 1 | Experimental | Procedure: Endodontic RetreatmentDuring the non-surgical retreatments, the rotary file systems used in our treatment consist of One Reci system 25.04, 25.06, 35.04, and 45.04 files in symptomatic teeth. |
| MICRO MEGA ONE CURVE MINI FILES in Group 2 | Experimental | Procedure: Endodontic RetreatmentDuring the non-surgical retreatments, the rotary file systems used in our treatment consist of One Curve mini system 25.04, 25.06, 35.04, and 45.04 files in symptomatic teeth. |
| MICRO MEGA ONE RECI FILES in Group 3 | Experimental | Procedure: Endodontic RetreatmentDuring the non-surgical retreatments, the rotary file systems used in our treatment consist of One Reci system 25.04, 25.06, 35.04, and 45.04 files in asymptomatic teeth. |
| MICRO MEGA ONE CURVE MINI FILES in Group 4 | Experimental | Procedure: Endodontic RetreatmentDuring the non-surgical retreatments, the rotary file systems used in our treatment consist of One Curve mini system 25.04, 25.06, 35.04, and 45.04 files in asymptomatic teeth. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic Apical Periodontitis
- Asymptomatic Apical Periodontitis
- Adult patients between 18-67 years aged
Key exclusion criteria (11 listed)
- Patient under 18 years old
- Complicating systemic disease
- Allergies to local anesthetic agents
- Acute apical abscesses
- Periodontal pockets deeper than 5 mm or more mobilty than level 1
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 |
|---|---|---|
| Endodontic RetreatmentA single operator procedured in one visit of non-surgical endodontic retreatment. Teeth were anesthetized using articaine hydrochloride with epinephrine 1:200,000 for mandibulary premolar teeth with one root canal. Each tooth was isolated with a rubber dam and then coronal restorations and caries were removed using sterile high-speed burs under water cooling. After preperation of the cavity access and localization of the canal orifice, all microorganisms that may have entered the root canal system are eliminated by removing the old canal filling with the One Flare and MicroMega REMOVER files in the MicroMega retreatment kit. | Procedure or surgery | MICRO MEGA ONE CURVE MINI FILES in Group 2, MICRO MEGA ONE CURVE MINI FILES in Group 4, MICRO MEGA ONE RECI FILES in Group 1, MICRO MEGA ONE RECI FILES in Group 3 |
Primary outcome
Post-operative pain
Time frame: Day 1, Day 2, Day 3, Day 7 and Day 14
After repeated root canal treatments, postoperative pain is frequent. The response to pain varies depending on the situation and perception of pain is not always continuous. The pain was evaluated with a visual analog scale (VAS) (0: no pain, 1-2: discomfort, 3-4: mild, 5: moderate, 6-7: severe, 8-9: very severe, 10: worst pain possible).
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 17 Apr 2024.
- Results publication: PubMed 32266988Nagendrababu V, Duncan HF, Bjorndal L, Kvist T, Priya E, Jayaraman J, Pulikkotil SJ, Dummer PMH. PRIRATE 2020 guidelines for reporting randomized trials in Endodontics: explanation and elaboration. Int Endod J. 2020 Jun;53(6):774-803. doi: 10.1111/iej.13304. Epub 2020 May 9.
- Derived from this study: PubMed 40958962Gunec HG, Pehlivan B, Topbas C, Kul AK, Sirin DA. Postoperative Pain Following Single-Visit Nonsurgical Retreatment Using Minimally Invasive Rotary vs. Reciprocating Nickel-Titanium File Systems: A Two-Arm Parallel Randomized Clinical Trial. Pain Res Manag. 2025 Sep 8;2025:6826535. doi: 10.1155/prm/6826535. eCollection 2025.
- Guidelines for reporting randomized trials in EndodonticsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Only after the results of the study are published in one of the international journals, they can be made available for the benefit of researchers, while any other data will not be shared.
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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.
Huseyin Gurkan Gunec, Asst Prof study director
Saglik Bilimleri University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endodontic Retreatment in people with Post-operative Pain and Retreatment, run by Saglik Bilimleri Universitesi 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 3 inclusion and 11 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 17 Apr 2024. 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?
Post-operative pain (time frame: Day 1, Day 2, Day 3, Day 7 and Day 14). 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 NCT06357481, 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 17 Apr 2024.