Postoperative PainNCT03791762
Incidence of Postoperative Pain After Root Canal Preparation Using Three Different Instruments
A study testing WaveOne Gold, Reciproc Blue and ProTaper Next in people with Postoperative Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
In an ideal endodontic treatment, maintenance of the original root canal morphology of the canal during root canal preparation, an ideal preparation and obturation is essential. Even if all stages are ideal, pain after endodontic treatment is a clinical condition that may occur after a few hours or several days. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- WaveOne Gold, Reciproc Blue and ProTaper Next
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 27 Dec 2018
- 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
- Patients with no systemic disease or condition
- Patients having a maxillary or mandibular teeth diagnosed with one of the plural and periodontal diseases (asymptomatic irreversible pulpitis, symptomatic irreversible pulpitis, symptomatic apical periodontitis or asymptomatic apical periodontitis)
Who cannot join
- Patients, who were diagnosed with acute or chronic apical abscesses
- Patients showing signs of systemic infection
- Patients with allergies to local anesthetic agents,
- Patients who are taking medication (analgesic, antibiotic or anti-inflammatory drugs) during the 7 days before the procedure
- Patients presenting with multiple teeth requiring treatment or having a progressive periodontal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Postoperative Pain After Root Canal Preparation Using Three Different Instrumentation System Manufactured From Different Ni-Ti Alloys
In an ideal endodontic treatment, maintenance of the original root canal morphology of the canal during root canal preparation, an ideal preparation and obturation is essential. Even if all stages are ideal, pain after endodontic treatment is a clinical condition that may occur after a few hours or several days. Post-operative pain after endodontic treatment is an undesirable condition which makes the clinician and the patient a distressing condition. Many clinical studies reported a 25-40% postoperative pain rate after endodontic treatment, which means that postoperative pain is a clinical symptom that should be considered for endodontist.
The ProTaper Next files (Dentsply Tulsa Dental Specialties) operate in continuous rotary motion, and their center of mass or center of rotation is positioned off-center relative to the instrument's central axis of rotation. During rotation, the files of this design produce a mechanical wave of motion, which travels along the length of the working part of the instrument, minimizing the contact between the file and dentin. According to the manufacturer, the offset design of this instrument also improves debris removal and flexibility in the working part of the file.
Read more
New heat treatment has been carried out on NiTi alloy, seeking to increase its flexibility and cyclic fatigue resistance. Recently, the Wave One Gold instrument, manufactured with a new thermal treatment called Gold treatment, was introduced on the market presenting some differences in design, size and taper compared to Wave One. Wave One Gold instrument has a parallelogram cross-sectional design, having two cutting edges, and consists of four instruments, 21/.06 (small), 25/07 (primary), 35/06 (medium) and 45/05 (large) while Wave One presents convex triangular cross-sectional design, besides larger size and taper.
Reciproc blue (REB, VDW), a new-generation reciprocating single-file system, is the latest version of REC. Like the REC file, REB also has an S-shaped cross section, 2 cutting edges, and a noncutting tip. However, REB files are manufactured by altering the molecular structure through a new heat treatment in order to increase the cyclic fatigue resistance. This new heat treatment gives the file its blue color. It was reported that REB files have approximately 2 times higher cyclic fatigue resistance than REC files. In addition, REB files can also be relatively prebent to better access curved canals.
However, the effect of Reciproc Blue, Protaper Next, Waveone Gold within preparation on the postoperative endodontic pain has not been investigated, yet. The aim of this prospective clinical trial was to clinically compare the incidence of postoperative pain after use of different nickel titanium file systems. The purpose of the present study was to evaluate the incidence of postoperative pain root canal preparation performed with Reciproc Blue, Protaper Next, Waveone Gold. The null hypothesis tested was that there is no difference in the incidence and severity of postoperative pain following with any of the 3 instruments.
Read the detailed description
In the study, 180 patients who were diagnosed with asymptomatic irreversible pulpitis, symptomatic irreversible pulpitis, acute apical periodontitis and chronic apical periodontitis, and who applied to the Endodontics clinic for inclusion in the endodontics clinic will be included. A female with systemic healthy patients who meet the inclusion criteria will be treated clinically and radiologically. The age and gender of the patient will be recorded as patient-dependent variables, and location and type of the tooth to be treated will be recorded as tooth-dependent variables. Before the root canal treatment, the responsible researcher will provide training on patients with the Vizual Analog Scale (VAS) and its use. Root canal treatments will be completed by this responsible investigator. Before starting root canal treatment, local anesthesia will be applied using 2: Lidocaine anesthetic solution containing 2: 80,000 epinephrine using the appropriate technique to the tooth. After anesthesia is provided, endodontic access cavities suitable for the teeth will be opened. The pulp tissue will be extruded using a turner. Subsequently, according to the entry path file to be used, the subjects will be assigned to the group that is selected from the closed envelopes that write the names of the groups, and random manual preparation will be divided into 3 groups: the R-Pilot file will be used, the rotation preparation will be used, and the ProGlider file will be used (n = 60). Working lengths will be determined by using K type file 10 and electronic apex finders. The manual preparation group will serve as the control group. In this group, K type hand files (Dentsply Sirona) # 08, 10, 15, respectively, will be used with the "forward and retract" technique proposed by Ruddle at the working length. The file will be moved clockwise and then counterclockwise, by rotating quarterly, the resistance will be advanced and retracted to the point where resistance is felt in the canal. This preparation will be made with each file until the working length is reached. In the rotation group where ProGlider file will be used, the entry way will be prepared at 300 rpm and 5 Ncm torque values using the torque-controlled endodontic motor (X-Smart) until the working length is reached with the crown-down technique. In the reciprocating movement group where the R-Pilot file will be used, the entry path will be prepared using the "Reciproc All" mode in the VDW-Silver endodontic engine. After the entryway preparation, standard procedures will be performed for all three groups. The channels will be prepared with ProTaper Next file system. During treatment, 10 mL of 5% NaOCl irrigation for each channel will be done using a 30-G irrigation needle. After the preparation, final irrigation will be done with 17% EDTA, distilled water and 5% NaOCl, respectively. In the samples in all three groups, after the root canals are dried with sterile paper cone, they will be filled with cold Plus lateral compaction technique with AH Plus canal paste and gutta percha cone. Patients' phone numbers will be taken, a copy of the VAS form will be delivered to the patients to be filled in, and it will be explained that postoperative pain measurements will be made with 6, 12, 18, 24, 36 and 48 hours of VAS. Patients will be reached by phone 48 hours after the completion of root canal treatments and information about their pain levels will be received. VAS values will be classified as follows: 0, no pain; 1-3, mild pain; 4-6, moderate pain; 7-10, severe pain. The use of analgesics will also be evaluated and recorded within the first 48 hours.
- Conditions
- Postoperative Pain
- Being tested
- WaveOne Gold, Reciproc Blue, ProTaper Next
- Keywords
- postoperative pain, WaveOne Gold, Reciproc Blue, ProTaper Next
- 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 GoldProcedure or surgery
Also called Reciprocating root canal preparation instruments, Dentsply Sirona, Ballaigues, Switzerland
WaveOne Gold was operated by an endomotor (VDW Gold, Munich, Germany) at "WaveOne ALL" setting.
Reciproc BlueProcedure or surgery
Also called Reciprocating root canal preparation instruments, VDW, Munich, Germany
Reciproc Blue was operated by an endomotor (VDW Gold, Munich, Germany) at "Reciproc ALL" setting.
ProTaper NextProcedure or surgery
Also called Rotating root canal preparation instrument, Dentsply Sirona, Ballaigues, Switzerland
ProTaper Next was operated by an endomotor (VDW Gold, Munich, Germany) with 16:1 contra angle at the settings suggested by the manufacturer (350 rpm, 3 Ncm).
| Study group | Role | What they receive |
|---|---|---|
| WaveOne Gold | Experimental | Root canal preparation with WaveOne Gold instrumentation system in a reciprocating manner Receives: Procedure: WaveOne Gold |
| Reciproc Blue | Experimental | Root canal preparation with Reciproc Blue instrumentation system in a reciprocating manner Receives: Procedure: Reciproc Blue |
| ProTaper Next | Experimental | Root canal preparation with ProTaper Next instrumentation system in a rotating manner Receives: Procedure: ProTaper Next |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Scores using Visual Analogue Scale
Visual analogue scale is a measure of pain intensity. In the present study, the visual analogue scale included a 10 cm straight horizontal line numbered at each centimetre from 0 to 10 showing two extreme symptoms of pain. "0" means no pain and "10" means the worst pain the subject has ever experienced. Each centimeter represents the pain intensity that the subject will mark orientated from 0 to 10. The intensity is increased from 0 to 10, therefore a higher score means a higher pain intensity and a worse outcome. 1-3 means "mild pain", 4-6 means "moderate pain" and 7-9 means "severe pain". There are no subscales.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start1 May 2018
- Primary completion25 Dec 2018
- Study completion27 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe 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
- Randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cangül Keskin, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791762
- Sponsor's protocol ID
- KAEK/389
- Status last verified
- Jul 2020
- First submitted
- 31 Dec 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postoperative Pain After Root Canal Preparation Using Three Different Instrumentation System Manufactured From Different Ni-Ti Alloys
- ClinicalTrials.gov ID
- NCT03791762
- Acronym / sponsor ID
- KAEK/389
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain, WaveOne Gold, Reciproc Blue, ProTaper Next
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 25 Dec 2018 (actual)
- Study completion
- 27 Dec 2018 (actual)
- First posted
- 3 Jan 2019 (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.
In an ideal endodontic treatment, maintenance of the original root canal morphology of the canal during root canal preparation, an ideal preparation and obturation is essential. Even if all stages are ideal, pain after endodontic treatment is a clinical condition that may occur after a few hours or several days. Post-operative pain after endodontic treatment is an undesirable condition which makes the clinician and the patient a distressing condition. Many clinical studies reported a 25-40% postoperative pain rate after endodontic treatment, which means that postoperative pain is a clinical symptom that should be considered for endodontist.
The ProTaper Next files (Dentsply Tulsa Dental Specialties) operate in continuous rotary motion, and their center of mass or center of rotation is positioned off-center relative to the instrument's central axis of rotation. During rotation, the files of this design produce a mechanical wave of motion, which travels along the length of the working part of the instrument, minimizing the contact between the file and dentin. According to the manufacturer, the offset design of this instrument also improves debris removal and flexibility in the working part of the file.
New heat treatment has been carried out on NiTi alloy, seeking to increase its flexibility and cyclic fatigue resistance. Recently, the Wave One Gold instrument, manufactured with a new thermal treatment called Gold treatment, was introduced on the market presenting some differences in design, size and taper compared to Wave One. Wave One Gold instrument has a parallelogram cross-sectional design, having two cutting edges, and consists of four instruments, 21/.06 (small), 25/07 (primary), 35/06 (medium) and 45/05 (large) while Wave One presents convex triangular cross-sectional design, besides larger size and taper.
Reciproc blue (REB, VDW), a new-generation reciprocating single-file system, is the latest version of REC. Like the REC file, REB also has an S-shaped cross section, 2 cutting edges, and a noncutting tip. However, REB files are manufactured by altering the molecular structure through a new heat treatment in order to increase the cyclic fatigue resistance. This new heat treatment gives the file its blue color. It was reported that REB files have approximately 2 times higher cyclic fatigue resistance than REC files. In addition, REB files can also be relatively prebent to better access curved canals.
However, the effect of Reciproc Blue, Protaper Next, Waveone Gold within preparation on the postoperative endodontic pain has not been investigated, yet. The aim of this prospective clinical trial was to clinically compare the incidence of postoperative pain after use of different nickel titanium file systems. The purpose of the present study was to evaluate the incidence of postoperative pain root canal preparation performed with Reciproc Blue, Protaper Next, Waveone Gold. The null hypothesis tested was that there is no difference in the incidence and severity of postoperative pain following with any of the 3 instruments.
Detailed description
In the study, 180 patients who were diagnosed with asymptomatic irreversible pulpitis, symptomatic irreversible pulpitis, acute apical periodontitis and chronic apical periodontitis, and who applied to the Endodontics clinic for inclusion in the endodontics clinic will be included. A female with systemic healthy patients who meet the inclusion criteria will be treated clinically and radiologically. The age and gender of the patient will be recorded as patient-dependent variables, and location and type of the tooth to be treated will be recorded as tooth-dependent variables. Before the root canal treatment, the responsible researcher will provide training on patients with the Vizual Analog Scale (VAS) and its use. Root canal treatments will be completed by this responsible investigator. Before starting root canal treatment, local anesthesia will be applied using 2: Lidocaine anesthetic solution containing 2: 80,000 epinephrine using the appropriate technique to the tooth. After anesthesia is provided, endodontic access cavities suitable for the teeth will be opened. The pulp tissue will be extruded using a turner. Subsequently, according to the entry path file to be used, the subjects will be assigned to the group that is selected from the closed envelopes that write the names of the groups, and random manual preparation will be divided into 3 groups: the R-Pilot file will be used, the rotation preparation will be used, and the ProGlider file will be used (n = 60). Working lengths will be determined by using K type file 10 and electronic apex finders. The manual preparation group will serve as the control group. In this group, K type hand files (Dentsply Sirona) # 08, 10, 15, respectively, will be used with the "forward and retract" technique proposed by Ruddle at the working length. The file will be moved clockwise and then counterclockwise, by rotating quarterly, the resistance will be advanced and retracted to the point where resistance is felt in the canal. This preparation will be made with each file until the working length is reached. In the rotation group where ProGlider file will be used, the entry way will be prepared at 300 rpm and 5 Ncm torque values using the torque-controlled endodontic motor (X-Smart) until the working length is reached with the crown-down technique. In the reciprocating movement group where the R-Pilot file will be used, the entry path will be prepared using the "Reciproc All" mode in the VDW-Silver endodontic engine. After the entryway preparation, standard procedures will be performed for all three groups. The channels will be prepared with ProTaper Next file system. During treatment, 10 mL of 5% NaOCl irrigation for each channel will be done using a 30-G irrigation needle. After the preparation, final irrigation will be done with 17% EDTA, distilled water and 5% NaOCl, respectively. In the samples in all three groups, after the root canals are dried with sterile paper cone, they will be filled with cold Plus lateral compaction technique with AH Plus canal paste and gutta percha cone. Patients' phone numbers will be taken, a copy of the VAS form will be delivered to the patients to be filled in, and it will be explained that postoperative pain measurements will be made with 6, 12, 18, 24, 36 and 48 hours of VAS. Patients will be reached by phone 48 hours after the completion of root canal treatments and information about their pain levels will be received. VAS values will be classified as follows: 0, no pain; 1-3, mild pain; 4-6, moderate pain; 7-10, severe pain. The use of analgesics will also be evaluated and recorded within the first 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| WaveOne Gold | Experimental | Procedure: WaveOne GoldRoot canal preparation with WaveOne Gold instrumentation system in a reciprocating manner |
| Reciproc Blue | Experimental | Procedure: Reciproc BlueRoot canal preparation with Reciproc Blue instrumentation system in a reciprocating manner |
| ProTaper Next | Experimental | Procedure: ProTaper NextRoot canal preparation with ProTaper Next instrumentation system in a rotating manner |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with no systemic disease or condition
- Patients having a maxillary or mandibular teeth diagnosed with one of the plural and periodontal diseases (asymptomatic irreversible pulpitis, symptomatic irreversible pulpitis, symptomatic apical periodontitis or asymptomatic apical periodontitis)
Key exclusion criteria (5 listed)
- Patients, who were diagnosed with acute or chronic apical abscesses
- Patients showing signs of systemic infection
- Patients with allergies to local anesthetic agents,
- Patients who are taking medication (analgesic, antibiotic or anti-inflammatory drugs) during the 7 days before the procedure
- Patients presenting with multiple teeth requiring treatment or having a progressive periodontal disease
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 GoldAlso: Reciprocating root canal preparation instruments, Dentsply Sirona, Ballaigues, SwitzerlandWaveOne Gold was operated by an endomotor (VDW Gold, Munich, Germany) at "WaveOne ALL" setting. | Procedure or surgery | WaveOne Gold |
| Reciproc BlueAlso: Reciprocating root canal preparation instruments, VDW, Munich, GermanyReciproc Blue was operated by an endomotor (VDW Gold, Munich, Germany) at "Reciproc ALL" setting. | Procedure or surgery | Reciproc Blue |
| ProTaper NextAlso: Rotating root canal preparation instrument, Dentsply Sirona, Ballaigues, SwitzerlandProTaper Next was operated by an endomotor (VDW Gold, Munich, Germany) with 16:1 contra angle at the settings suggested by the manufacturer (350 rpm, 3 Ncm). | Procedure or surgery | ProTaper Next |
Primary outcome
Postoperative Pain Scores using Visual Analogue Scale
Time frame: 72 hours
Visual analogue scale is a measure of pain intensity. In the present study, the visual analogue scale included a 10 cm straight horizontal line numbered at each centimetre from 0 to 10 showing two extreme symptoms of pain. "0" means no pain and "10" means the worst pain the subject has ever experienced. Each centimeter represents the pain intensity that the subject will mark orientated from 0 to 10. The intensity is increased from 0 to 10, therefore a higher score means a higher pain intensity and a worse outcome. 1-3 means "mild pain", 4-6 means "moderate pain" and 7-9 means "severe pain". There are no subscales.
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 14 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WaveOne Gold, Reciproc Blue and ProTaper Next in people with Postoperative Pain, run by Ondokuz Mayıs 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 2 inclusion and 5 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 14 Jul 2020. 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 Scores using Visual Analogue Scale (time frame: 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 14 Jul 2020.