Post-Op ComplicationNCT04700995
Postoperative Pain After Using NiTi Instruments
A study testing NiTi instruments in people with Post-Op Complication and Endodontic Inflammation, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized clinical trial was to compare the incidence, intensity and duration of postoperative pain following the removal of root canal obturation materials canals using rotary (ProTaper Universal or Hyflex EDM) or reciprocating file (Reciproc Blue or WaveOne Gold) systems. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Op Complication, Endodontic Inflammation, Endodontically Treated Teeth
- What is being tested?
- NiTi instruments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 10 Sep 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy patient who has a failed root canal treatment.
- Asymptomatic single rooted teeth that had an initial root canal filling diagnosed with chronic apical periodontitis.
- Patients agreed to parcitipate in the study
Who cannot join
- Overfilled teeth,
- teeth with intraradicular posts,
- existence of a sinus tract,
- consumption of antibiotics or analgesics within one month,
- pregnancy,
- history of trauma,
- traumatic occlusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain After Endodontic Retreatment Using Different Rotary or Reciprocating Instruments: A Randomized, Controlled Clinical Trial
The aim of this randomized clinical trial was to compare the incidence, intensity and duration of postoperative pain following the removal of root canal obturation materials canals using rotary (ProTaper Universal or Hyflex EDM) or reciprocating file (Reciproc Blue or WaveOne Gold) systems. The null hypothesis tested was that there is no difference in postoperative pain following the retreatment procedure between the four systems used.
Read the detailed description
Postoperative pain (PP) is not a certain reason for the long term success of root canal treatment. However, PP control is important for patient comfort and satisfaction. Apical extrusion of debris containing dentin, necrotic pulp tissue, microorganisms, and/or irrigation solutions may occur during retreatment procedures which may result in the induction of periapical inflammation, postoperative pain, and delayed periapical healing. All available techniques and instruments are associated with apical extrusion of debris to some degree during the root canal preparation or removal of the obturation materials. The aim of this randomized clinical trial was to compare the incidence, intensity and duration of postoperative pain following the removal of root canal obturation materials canals using rotary or reciprocating file systems.
Patients referred for non-surgical endodontic retreatment were included. Hundred and eighty cases were selected on the basis of the determined inclusion criteria and randomly allocated to four groups (n = 45).
ProTaper Universal group D1, D2 and D3 files were used respectively with a full rotational motion with a endodontic motor until working was reached as recommended by the manufacturer.
Hylex EDM group Hylex EDM files were used with a full rotational motion with a endodontic motor until the working was reached.
Reciproc Blue group R25 files were used with a reciprocating motion using with the "RECIPROC ALL" mode with a slow in-and-out pecking motion, and the amplitude of pecking movements did not exceed 3 mm until the working lenght was reached.
Waveone Gold group Primary files were used with a reciprocating motion using with the "WAVEONE ALL" mode with a slow in-and-out pecking motion, and the amplitude of pecking movements did not exceed 3 mm until the working was reached.
Assessment of postoperative pain Before participation, all patients had read and signed an informed consent form., all patients were given a pain report form on which they would report their preoperative level of pain.
Before beginning of treatment, the clinician filled in an example of pain report with each patient to confirm that they understood the instructions.
The degree of the postoperative pain was measured using an 11-level numeric rating scale (NRS) at 24, 48, and 72 h following the retreatment. The NRS is a segmented numeric version of the visual analog scale (VAS) and consists of successive numbers from 0 to 10 on a horizontal line. The respondent selects a number that best represents the intensity of his pain. Number "0" represents "no pain" whereas number "10" represents "the worst pain imaginable".
Patients were asked to fill out forms at relevant times in accordance with the instructions given.
An analgesic tablet (400 mg Ibuprofen) was prescribed to take an in case of severe pain, at 6-h intervals. Also they were requested to record the number of analgesic pills consumed each day. The forms were collected on the 4th day following the retreatment. Also a phone call was made every day for 3 days to obtain information on the postoperative pain and the frequency of analgesic intake. The patients were asked to call the contact number on the form if they encountered severe pain or if they needed to ask any questions regarding the treatment.
- Conditions
- Post-Op Complication, Endodontic Inflammation, Endodontically Treated Teeth, Apical Periodontitis
- Being tested
- NiTi instruments
- Keywords
- non-surgical endodontic retreatment, post operative pain, rotary NiTi instrument, reciprocating NiTi instrument, ProTaper Universal, ProTaper Gold, Hyflex EDM, Reciproc Blue, WaveOne Gold
- Medical subject headings
- Postoperative Complications, Pulpitis, Tooth, Nonvital, Periapical Periodontitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiTi instrumentsProcedure or surgery
Root canal filling removal
| Study group | Role | What they receive |
|---|---|---|
| ProTaper rotary NiTi instruments | Experimental | The ProTaper Universal Retreatment rotary system and ProTaper Gold rotary system were used. Receives: Procedure: NiTi instruments |
| Hyflex EDM rotary NiTi instruments | Experimental | Hyflex EDM rotary system was used. Receives: Procedure: NiTi instruments |
| Reciproc Blue reciprocating NiTi instruments | Experimental | Reciproc Blue reciprocating system was used. Receives: Procedure: NiTi instruments |
| Waveone Gold reciprocating NiTi instruments | Experimental | WaveOne Gold reciprocating system was used. Receives: Procedure: NiTi instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain after removal of gutta-percha using four different NiTi systems.
Pain intensity was evaluated at 24 hours after retreatment procedures. An 11 item numerical rating scale (NSR) was used to assess the pain. The NSR is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The number 0 represents "no pain" wheres number 10 represents "pain as bad as someone can imagine". All patients were requested to mark a number corresponding to their average pain.
Measured: 24 hours postoperatively
Secondary outcomes (1)
Postoperative pain after removal of gutta-percha using four different NiTi systems.
Pain intensity was evaluated at 48 hours after retreatment procedures. An 11 item numerical rating scale (NSR) was used to assess the pain. The NSR is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The number 0 represents "no pain" wheres number 10 represents "pain as bad as someone can imagine". All patients were requested to mark a number corresponding to their average pain.
Measured: 24 to 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 May 2020
- Primary completion1 Sep 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Op ComplicationStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burhan Can Çanakçi, Trakya University
- Investigators
- Burhan Çanakçi, Principal investigator, Trakya University, Faculty of DentistryÖzgür Er, Study director, Trakya University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700995
- Sponsor's protocol ID
- TrakyaU 2020/150
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2021
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Endodontic Retreatment Using Different Rotary or Reciprocating Instruments: A Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04700995
- Acronym / sponsor ID
- TrakyaU 2020/150
- Conditions
- Post-Op Complication, Endodontic Inflammation, Endodontically Treated Teeth, Apical Periodontitis
- Keywords
- non-surgical endodontic retreatment, post operative pain, rotary NiTi instrument, reciprocating NiTi instrument, ProTaper Universal, ProTaper Gold, Hyflex EDM, Reciproc Blue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 8 Jan 2021 (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.
The aim of this randomized clinical trial was to compare the incidence, intensity and duration of postoperative pain following the removal of root canal obturation materials canals using rotary (ProTaper Universal or Hyflex EDM) or reciprocating file (Reciproc Blue or WaveOne Gold) systems. The null hypothesis tested was that there is no difference in postoperative pain following the retreatment procedure between the four systems used.
Detailed description
Postoperative pain (PP) is not a certain reason for the long term success of root canal treatment. However, PP control is important for patient comfort and satisfaction. Apical extrusion of debris containing dentin, necrotic pulp tissue, microorganisms, and/or irrigation solutions may occur during retreatment procedures which may result in the induction of periapical inflammation, postoperative pain, and delayed periapical healing. All available techniques and instruments are associated with apical extrusion of debris to some degree during the root canal preparation or removal of the obturation materials. The aim of this randomized clinical trial was to compare the incidence, intensity and duration of postoperative pain following the removal of root canal obturation materials canals using rotary or reciprocating file systems.
Patients referred for non-surgical endodontic retreatment were included. Hundred and eighty cases were selected on the basis of the determined inclusion criteria and randomly allocated to four groups (n = 45).
ProTaper Universal group D1, D2 and D3 files were used respectively with a full rotational motion with a endodontic motor until working was reached as recommended by the manufacturer.
Hylex EDM group Hylex EDM files were used with a full rotational motion with a endodontic motor until the working was reached.
Reciproc Blue group R25 files were used with a reciprocating motion using with the "RECIPROC ALL" mode with a slow in-and-out pecking motion, and the amplitude of pecking movements did not exceed 3 mm until the working lenght was reached.
Waveone Gold group Primary files were used with a reciprocating motion using with the "WAVEONE ALL" mode with a slow in-and-out pecking motion, and the amplitude of pecking movements did not exceed 3 mm until the working was reached.
Assessment of postoperative pain Before participation, all patients had read and signed an informed consent form., all patients were given a pain report form on which they would report their preoperative level of pain.
Before beginning of treatment, the clinician filled in an example of pain report with each patient to confirm that they understood the instructions.
The degree of the postoperative pain was measured using an 11-level numeric rating scale (NRS) at 24, 48, and 72 h following the retreatment. The NRS is a segmented numeric version of the visual analog scale (VAS) and consists of successive numbers from 0 to 10 on a horizontal line. The respondent selects a number that best represents the intensity of his pain. Number "0" represents "no pain" whereas number "10" represents "the worst pain imaginable".
Patients were asked to fill out forms at relevant times in accordance with the instructions given.
An analgesic tablet (400 mg Ibuprofen) was prescribed to take an in case of severe pain, at 6-h intervals. Also they were requested to record the number of analgesic pills consumed each day. The forms were collected on the 4th day following the retreatment. Also a phone call was made every day for 3 days to obtain information on the postoperative pain and the frequency of analgesic intake. The patients were asked to call the contact number on the form if they encountered severe pain or if they needed to ask any questions regarding the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ProTaper rotary NiTi instruments | Experimental | Procedure: NiTi instrumentsThe ProTaper Universal Retreatment rotary system and ProTaper Gold rotary system were used. |
| Hyflex EDM rotary NiTi instruments | Experimental | Procedure: NiTi instrumentsHyflex EDM rotary system was used. |
| Reciproc Blue reciprocating NiTi instruments | Experimental | Procedure: NiTi instrumentsReciproc Blue reciprocating system was used. |
| Waveone Gold reciprocating NiTi instruments | Experimental | Procedure: NiTi instrumentsWaveOne Gold reciprocating system was used. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Systemically healthy patient who has a failed root canal treatment.
- Asymptomatic single rooted teeth that had an initial root canal filling diagnosed with chronic apical periodontitis.
- Patients agreed to parcitipate in the study
Key exclusion criteria (7 listed)
- Overfilled teeth,
- teeth with intraradicular posts,
- existence of a sinus tract,
- consumption of antibiotics or analgesics within one month,
- pregnancy,
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 |
|---|---|---|
| NiTi instrumentsRoot canal filling removal | Procedure or surgery | Hyflex EDM rotary NiTi instruments, ProTaper rotary NiTi instruments, Reciproc Blue reciprocating NiTi instruments, Waveone Gold reciprocating NiTi instruments |
Primary outcome
Postoperative pain after removal of gutta-percha using four different NiTi systems.
Time frame: 24 hours postoperatively
Pain intensity was evaluated at 24 hours after retreatment procedures. An 11 item numerical rating scale (NSR) was used to assess the pain. The NSR is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The number 0 represents "no pain" wheres number 10 represents "pain as bad as someone can imagine". All patients were requested to mark a number corresponding to their average pain.
1 secondary outcome
Postoperative pain after removal of gutta-percha using four different NiTi systems.
Time frame: 24 to 48 hours postoperatively
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 13 Jan 2021.
- 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.
Burhan Çanakçi principal investigator
Trakya University, Faculty of Dentistry
Özgür Er study director
Trakya University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NiTi instruments in people with Post-Op Complication and Endodontic Inflammation, run by Trakya 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 3 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 13 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?
Postoperative pain after removal of gutta-percha using four different NiTi systems. (time frame: 24 hours postoperatively). 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 13 Jan 2021.