Postoperative PainNCT05042713
The Effect of Using Different Single File Systems With Coronal Flaring Instruments on Postoperative Pain
A study testing WaveOne Gold, One Curve, OneFlare in people with Postoperative Pain, run by Yuzuncu Yil University.
Trial summary
Pain after root canal treatment is an important problem that affects the quality of life of patients. Common factors affecting the formation of pain after root canal treatment include insufficient root canal shaping, irrigation solution extrusion, intracanal medicament extrusion, hyperocclusion, missed canals… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- WaveOne Gold, One Curve, OneFlare
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Jul 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy persons between the ages of 18 and 45 years
- Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis
Who cannot join
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with calcified canals
- Teeth with periodontal diseases
- Teeth with sensitive to percussion and palpation
- Teeth with root resorption
- Teeth with immature/open apex
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Use of Reciprocation and Rotational Single File Systems With the OneFlare Coronal Flaring Instrument on Postoperative Pain
Pain after root canal treatment is an important problem that affects the quality of life of patients. Common factors affecting the formation of pain after root canal treatment include insufficient root canal shaping, irrigation solution extrusion, intracanal medicament extrusion, hyperocclusion, missed canals, presence of pre-procedural pain, presence of periapical pathology, and extrusion of apical debris . It has been reported that the file systems and instrumentation technique used in root canal preparation affect apical extrusion, which is the main cause of postoperative pain . It has been reported that single-file systems introduced to the market to shorten root canal treatment time cause less postoperative pain than multi-file systems. However, there are different opinions about the effect of reciprocal and rotational file systems on postoperative pain.
It has been reported that coronal flaring during root canal shaping facilitates apical access of instruments and irrigation solution. NiTi instruments generally tend to orient tissue debris coronally, coronal shaping can create a reservoir for collecting debris accumulated in the coronal portion of the root. Therefore, increasing the coronal space for debris reduces the amount of apically removed extrusion. However, single file systems do not have a coronal flaring file and canal preparation is completed with a single file. An increased amount of apical extrusion may occur due to insufficient coronal shaping during canal preparation using single-file systems.
In this study, the effect of the use of coronal flaring file together with rotational and reciprocal single file systems on postoperative pain will be investigated, since there are different results about the effects of rotational and reciprocal file systems on postoperative pain, and although it has been reported that coronal flaring reduces apical extrusion, there is no study that determines the effect on postoperative pain. Thus, it is aimed to reduce the pain after root canal treatment and to have a more comfortable and painless process after the procedure.
Read the detailed description
The study is planned to be conducted on a total of 80 patients aged between 18-45 who were diagnosed and followed up in Van Yüzüncü Yıl University, Faculty of Dentistry, Department of Endodontics. Patients with no systemic disease, diagnosis of irreversible pulpitis, single rooted and single canal lower premolar tooth will be included in the case group. Patients with resorption and calcification in the roots of their teeth, incomplete root development, pregnant and lactating patients, who have taken analgesics or anti-inflammatory drugs in the last 12 hours and cannot use a rubber dam for root canal treatment will not be included in the study. After obtaining informed consent from the patients, local anesthesia (Ultracain DS Fort, Hoechst-Marian Roussel, Frankfurt, Germany) will be administer to the tooth for which root canal treatment will be applied. Under the rubber dam isolation, the access cavity will be opened with diamond burs. Working length will be determined using a #15 K file (Mani Inc, Tochigi, Japan) and electronic apex locator (Propex Pixi, Dentsply Maillefer, Switzerland).
Patients will be divided into 4 groups according to the file systems to be used in root canal treatment;
Group 1: Wave One Gold Group 2: One Flare + Wave One Gold Group 3: One Curve Group 4: One Flare + One Curve
During the shaping process, 5.25% NaOCI and 17% EDTA will be used as irrigation solution. NaviTip irrigation needle (30-G; Ultradent Products Inc, South Jordan, USA) will be used for irrigation during shaping. After the root canal shaping is completed, the canals will be rinsed with distilled water as a final irrigation and the root canals will be filled with gutta percha and Adseal (Meta Biomed, Cheongju, North Korea) root canal sealer using the single cone technique. Teeth will be restored with composite. Patients will be prescribed 400 mg of ibuprofen anti-inflammatory medication to use in case of severe pain. The pain levels of the lines before and after the procedure will be evaluated with the VAS (Visual analogue scale) pain scale. Patients will be given a 10 cm paper ruler to record their pain levels over 6, 12, 24, 48, 72 hours and 1 week periods. Patients will be told how to score their pain levels and will be asked to mark their pain levels on the given ruler at the specified times. At the end of the 1-week period, the tables will be collected from the patients and statistical analysis will be made and interpreted for the data.
- Conditions
- Postoperative Pain
- Being tested
- WaveOne Gold, One Curve, OneFlare
- Keywords
- root canal, coronal flaring, single file system, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaveOne Gold, One Curve, OneFlareOther
During the endodontic treatment of molar teeth diagnosed with irreversible pulpitis, the effect on postoperative pain when single file systems with rotational (OneCurve) and reciprocal (WaveOne Gold) kinematics are used with and without coronal flaring instrument (OneFlare) will be compared.
| Study group | Role | What they receive |
|---|---|---|
| Wave One Gold | Active comparator | The Wave One Gold file will be used with the VDW endodontic motor (VDW) in accordance with the manufacturer's recommendations. Receives: Other: WaveOne Gold, One Curve, OneFlare |
| One Flare and Wave One Gold file system | Active comparator | The One Flare file will be used with a rotational speed of 300 rpm and 3 N/cm torque at a working length of 3 mm. After the Wave One Gold file will be used with the VDW endodontic motor (VDW) in accordance with the manufacturer's recommendations. Receives: Other: WaveOne Gold, One Curve, OneFlare |
| One Curve | Active comparator | The One Curve file (Size 25) will be used in the VDW endodontic motor (VDW) in continuous rotation at 300 rpm and 2.5 Ncm torque in accordance with the manufacturer's recommendations. Receives: Other: WaveOne Gold, One Curve, OneFlare |
| One Curve with One Flare | Active comparator | The One Flare file will be used with a rotational speed of 300 rpm and 3 N/cm torque at a working length of 3 mm. After the One Curve file (Size 25) will be used in the VDW endodontic motor (VDW) in continuous rotation at 300 rpm and 2.5 Ncm torque in accordance with the manufacturer's recommendations. Receives: Other: WaveOne Gold, One Curve, OneFlare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score Scala
Postoperative pain will be assessed with a visual analog score after endodontic treatment.
Measured: The change in the postoperative pain levels by the patient at the 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and at the end of 1 week will be compared.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Sep 2021 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative 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
- Patients will be divided into 4 groups according to the file systems to be used in root canal treatment; Group 1: Wave One Gold Group 2: One Flare + Wave One Gold Group 3: One Curve Group 4: One Flare + One Curve.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esin Özlek, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042713
- Sponsor's protocol ID
- 05/22.06.2021
- Status last verified
- Sep 2021
- First submitted
- 25 Aug 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pedulla E, Genovesi F, Rapisarda S, La Rosa GR, Grande NM, Plotino G, Adorno CG. Effects of 6 Single-File Systems on Dentinal Crack Formation. J Endod. 2017 Mar;43(3):456-461. doi: 10.1016/j.joen.2016.10.038. Epub 2017 Jan 25.
PubMed 28131416
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Use of Reciprocation and Rotational Single File Systems With the OneFlare Coronal Flaring Instrument on Postoperative Pain
- ClinicalTrials.gov ID
- NCT05042713
- Acronym / sponsor ID
- 05/22.06.2021
- Conditions
- Postoperative Pain
- Keywords
- root canal, coronal flaring, single file system, postoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 13 Sep 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.
Pain after root canal treatment is an important problem that affects the quality of life of patients. Common factors affecting the formation of pain after root canal treatment include insufficient root canal shaping, irrigation solution extrusion, intracanal medicament extrusion, hyperocclusion, missed canals, presence of pre-procedural pain, presence of periapical pathology, and extrusion of apical debris . It has been reported that the file systems and instrumentation technique used in root canal preparation affect apical extrusion, which is the main cause of postoperative pain . It has been reported that single-file systems introduced to the market to shorten root canal treatment time cause less postoperative pain than multi-file systems. However, there are different opinions about the effect of reciprocal and rotational file systems on postoperative pain.
It has been reported that coronal flaring during root canal shaping facilitates apical access of instruments and irrigation solution. NiTi instruments generally tend to orient tissue debris coronally, coronal shaping can create a reservoir for collecting debris accumulated in the coronal portion of the root. Therefore, increasing the coronal space for debris reduces the amount of apically removed extrusion. However, single file systems do not have a coronal flaring file and canal preparation is completed with a single file. An increased amount of apical extrusion may occur due to insufficient coronal shaping during canal preparation using single-file systems.
In this study, the effect of the use of coronal flaring file together with rotational and reciprocal single file systems on postoperative pain will be investigated, since there are different results about the effects of rotational and reciprocal file systems on postoperative pain, and although it has been reported that coronal flaring reduces apical extrusion, there is no study that determines the effect on postoperative pain. Thus, it is aimed to reduce the pain after root canal treatment and to have a more comfortable and painless process after the procedure.
Detailed description
The study is planned to be conducted on a total of 80 patients aged between 18-45 who were diagnosed and followed up in Van Yüzüncü Yıl University, Faculty of Dentistry, Department of Endodontics. Patients with no systemic disease, diagnosis of irreversible pulpitis, single rooted and single canal lower premolar tooth will be included in the case group. Patients with resorption and calcification in the roots of their teeth, incomplete root development, pregnant and lactating patients, who have taken analgesics or anti-inflammatory drugs in the last 12 hours and cannot use a rubber dam for root canal treatment will not be included in the study. After obtaining informed consent from the patients, local anesthesia (Ultracain DS Fort, Hoechst-Marian Roussel, Frankfurt, Germany) will be administer to the tooth for which root canal treatment will be applied. Under the rubber dam isolation, the access cavity will be opened with diamond burs. Working length will be determined using a #15 K file (Mani Inc, Tochigi, Japan) and electronic apex locator (Propex Pixi, Dentsply Maillefer, Switzerland).
Patients will be divided into 4 groups according to the file systems to be used in root canal treatment;
Group 1: Wave One Gold Group 2: One Flare + Wave One Gold Group 3: One Curve Group 4: One Flare + One Curve
During the shaping process, 5.25% NaOCI and 17% EDTA will be used as irrigation solution. NaviTip irrigation needle (30-G; Ultradent Products Inc, South Jordan, USA) will be used for irrigation during shaping. After the root canal shaping is completed, the canals will be rinsed with distilled water as a final irrigation and the root canals will be filled with gutta percha and Adseal (Meta Biomed, Cheongju, North Korea) root canal sealer using the single cone technique. Teeth will be restored with composite. Patients will be prescribed 400 mg of ibuprofen anti-inflammatory medication to use in case of severe pain. The pain levels of the lines before and after the procedure will be evaluated with the VAS (Visual analogue scale) pain scale. Patients will be given a 10 cm paper ruler to record their pain levels over 6, 12, 24, 48, 72 hours and 1 week periods. Patients will be told how to score their pain levels and will be asked to mark their pain levels on the given ruler at the specified times. At the end of the 1-week period, the tables will be collected from the patients and statistical analysis will be made and interpreted for the data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients will be divided into 4 groups according to the file systems to be used in root canal treatment; Group 1: Wave One Gold Group 2: One Flare + Wave One Gold Group 3: One Curve Group 4: One Flare + One Curve.
| Arm | Type | Receives |
|---|---|---|
| Wave One Gold | Active comparator | Other: WaveOne Gold, One Curve, OneFlareThe Wave One Gold file will be used with the VDW endodontic motor (VDW) in accordance with the manufacturer's recommendations. |
| One Flare and Wave One Gold file system | Active comparator | Other: WaveOne Gold, One Curve, OneFlareThe One Flare file will be used with a rotational speed of 300 rpm and 3 N/cm torque at a working length of 3 mm. After the Wave One Gold file will be used with the VDW endodontic motor (VDW) in accordance with the manufacturer's recommendations. |
| One Curve | Active comparator | Other: WaveOne Gold, One Curve, OneFlareThe One Curve file (Size 25) will be used in the VDW endodontic motor (VDW) in continuous rotation at 300 rpm and 2.5 Ncm torque in accordance with the manufacturer's recommendations. |
| One Curve with One Flare | Active comparator | Other: WaveOne Gold, One Curve, OneFlareThe One Flare file will be used with a rotational speed of 300 rpm and 3 N/cm torque at a working length of 3 mm. After the One Curve file (Size 25) will be used in the VDW endodontic motor (VDW) in continuous rotation at 300 rpm and 2.5 Ncm torque in accordance with the manufacturer's recommendations. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy persons between the ages of 18 and 45 years
- Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis
Key exclusion criteria (7 listed)
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with calcified canals
- Teeth with periodontal diseases
- Teeth with sensitive to percussion and palpation
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 |
|---|---|---|
| WaveOne Gold, One Curve, OneFlareDuring the endodontic treatment of molar teeth diagnosed with irreversible pulpitis, the effect on postoperative pain when single file systems with rotational (OneCurve) and reciprocal (WaveOne Gold) kinematics are used with and without coronal flaring instrument (OneFlare) will be compared. | Other | One Curve, One Curve with One Flare, One Flare and Wave One Gold file system, Wave One Gold |
Primary outcome
Visual Analog Score Scala
Time frame: The change in the postoperative pain levels by the patient at the 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and at the end of 1 week will be compared.
Postoperative pain will be assessed with a visual analog score after endodontic treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Background: PubMed 28131416Pedulla E, Genovesi F, Rapisarda S, La Rosa GR, Grande NM, Plotino G, Adorno CG. Effects of 6 Single-File Systems on Dentinal Crack Formation. J Endod. 2017 Mar;43(3):456-461. doi: 10.1016/j.joen.2016.10.038. Epub 2017 Jan 25.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing WaveOne Gold, One Curve, OneFlare in people with Postoperative Pain, run by Yuzuncu Yil University.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hacer Şahin Aydınyurt, Phd (905304589710, hacersahin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Score Scala (time frame: The change in the postoperative pain levels by the patient at the 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and at the end of 1 week will be compared.). 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 NCT05042713, which also lists 1 linked publication.
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 Sep 2021.