Postoperative PainNCT05927025
Can the Different Instruments Used ın Root Canal Treatment Have an Effect on Postoperative Pain?
A study testing Hand K-files in people with Postoperative Pain, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Root canal treatment is a treatment method in which the pulp is irreversibly infected due to caries or trauma or when the pulp loses its vitality. Biomechanical preparation of primary teeth is an important step for a successful root canal treatment. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Hand K-files
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 18 Jan 2023
- 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- No analgesic use 12 hours before root canal treatment
- No systemic disease.
- Teeth with a diagnosis of irreversible pulpitis, no other teeth causing pain at the site of the tooth to be treated, no inter-root bone loss exceeding 1/3, and root canal inclinations of no more than 25° according to Schneider method were included in the study.
Who cannot join
- Patients with post-procedural analgesic use were excluded from the study
- Patients whose parents did not fully understand the instructions and who did not attend the follow-up visit one week after treatment were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Different NiTi Rotary Files With NiTi Hand Files to Postoperative Pain Effects : A Randomized Controlled Clinical Trial
Root canal treatment is a treatment method in which the pulp is irreversibly infected due to caries or trauma or when the pulp loses its vitality. Biomechanical preparation of primary teeth is an important step for a successful root canal treatment. The success of root canal treatment depends not only on the biological results of the treatment, but also on minimizing the postoperative pain of the patients. Therefore, the elimination of factors associated with postoperative pain has an important role in the prognosis of patients after treatment. In all root canal preparation methods, some debris overflows from the apical. Debris protruding into the apical area causes postoperative pain. Many studies in the literature have shown that NiTi rotary files cause less extrusion of debris compared to hand files, and therefore less postoperative pain. Within the scope of this study, the effect of NiTi K hand file and WaveOne Gold, ProTaper Next, EndoArt NiTi Pedo Gold file, AF Baby rotary file systems on postoperative pain in root canal treatment preparations applied to the mandibular primary molar teeth of pediatric patients aged 5-8 years. It is intended to be evaluated using VAS).
In our research; ProTaper Next (PTN), WaveOne Gold (WOG), AF Baby rotary file, EndoArt NiTi Pedo Gold file, NiTi K type hand files were used. 100 patients between the ages of 5 and 8 who had root canal treatment indications for mandibular primary second molars were included in the study. The patients were divided into 5 groups with 20 patients in each group. All systems were used according to the manufacturer's instructions and all treatments were performed by a single operator in a single session. Postoperative pain was recorded using the Visual Analog Scale (VAS) at the 6th, 12th, 18th, 24th, 48th, 72nd hour and 1st week following treatment. The obtained data were evaluated statistically.
- Conditions
- Postoperative Pain
- Being tested
- Hand K-files
- Keywords
- Root canal treatment, Nickel-Titanium instruments, Postoperative pain, Primary tooth
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand K-filesProcedure or surgery
Also called ProTaper Next, WaveOne Gold, AF Baby Rotary File, EndoArt NiTi Pedo Golf File
It is used for cleaning and shaping root canals.
| Study group | Role | What they receive |
|---|---|---|
| Hand K-files | Experimental | NiTi K type hand file (Perfect Medical Instrument Co., Ltd. Shenzhen, China), Contrary to stainless steel files, turning is produced with the buckling method. torsional resistance and bending resistance of files compared to stainless steel files found more successful in comparison. 16 mm of the files are finished It has the edge. Our Work is 25mm long; 15K (white), 20K (yellow), 25K (red), 30 K (blue) files were used. NiTi K type #15, #20, #25, and #30 hand files were used with a quarter-turn pulling motion, respectively. Receives: Procedure: Hand K-files |
| ProTaper Next | Experimental | The ProTaper Next (PTN) system is produced by adding M-Wire alloy to the ProTaper Universal (PU) system. With the M-Wire alloy, it is aimed to increase the flexibility and cyclic fatigue resistance of the files. The combination of three important design features in PTN files, including changing taper on a single file, M-wire technology and offset design, is one of the important features that distinguish it from other files. PTN X1 and X2 files have both an ascending and a descending conical design on a single file; PTN X3, X4 and X5 files have a constant taper from D1-D3, then taper design that tapers off over the rest of their active segments. Receives: Procedure: Hand K-files |
| WaveOne Gold | Experimental | They are produced by applying Gold-wire process to the WaveOne (WO) system. The WOG file system exhibits repetitive back-and-forth mutual 'reciprocation' motion during preparation, in contrast to the continuous rotational motion. While rotating 150° counterclockwise during the reciprocating motion, clockwise It turns 30° in the direction of, and after 3 cycles, it completes 1 full cycle. Thus, it contributed positively to the file reaching the apical without applying excessive pressure, increasing the cutting efficiency, and accelerating the coronal movement of the debris. Small (yellow-20/0.07), WO Primary (red-25/0.07), and WOG Medium (green-35/0.06) files were used with the appropriate speed and torque values recommended by the manufacturer (300 rpm and 2.0 Ncm) by applying crown down technique. WOG files were operated in a reciprocating motion (150° counterclockwise, 30° clockwise). Receives: Procedure: Hand K-files |
| AF Baby Rotary File | Experimental | AF Baby rotary file is specially designed for milk teeth. Entry file 11 mm other the files are 16 mm long and consist of 4 different rotary instruments; (17/.08), (20/.04), (25/.04) and (30/.04).The cross-sections of the files are triangular and heat treatment is applied to the NiTi wire. produced as a result. Thus, an increase in resistance to cyclic fatigue and an increase in dentin It is aimed to reduce screwing. Root canal thanks to its flexibility It adapts very well to the curvatures in its anatomy. AF Baby rotary files #20, #25, and #30 were used with the crown down technique with the appropriate speed and torque values (350 rpm and 2.0 Ncm) recommended by the manufacturer. Receives: Procedure: Hand K-files |
| EndoArt NiTi Pedo Golf File | Experimental | EndoArt NiTi Pedo Gold file is specially designed for primary teeth. 18mm length consists of 4 different rotary tools: (15/06) white, (20/04) yellow, (25/04) red, (30/04) blue. The cross-sections of the files are triangular, and Gold wire technology is used in the production phase. were produced using Thus, a titanium oxide layer on the surface of the instrument Happened. Thus, it is more flexible and more flexible than conventional NiTi alloys. resistant and 2 times better cyclic fatigue resistance than conventional files exists. EndoArt NiTi Pedo Golf File; EndoArt NiTi Pedo Gold #15, #20, and #30 files were used with the crown down technique with the appropriate speed and torque values recommended by the manufacturer (350 rpm and 2.0 Ncm). Receives: Procedure: Hand K-files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Assessments
Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 6th hour was evaluated. All parents participating in the study were blinded to the treatment protocol used for the children. Evaluation of postoperative pain was performed using the VAS . It was explained that the closest score between "0" no pain and "10" severe pain scores should be recorded by the parents.
Measured: 6 hours
Postoperative Pain Assessments
Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 12th hour was evaluated. All parents participating in the study were blinded to the treatment protocol used for the children. Evaluation of postoperative pain was performed using the VAS. It was explained that the closest score between "0" no pain and "10" severe pain scores should be recorded by the parents.
Measured: 12 hours
Postoperative Pain Assessments
Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 24th hour was evaluated. All parents participating in the study were blinded to the treatment protocol used for the children. Evaluation of postoperative pain was performed using the VAS. It was explained that the closest score between "0" no pain and "10" severe pain scores should be recorded by the parents.
Measured: 24 hours
Postoperative Pain Assessments
Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 48th hour was evaluated. All parents participating in the study were blinded to the treatment protocol used for the children. Evaluation of postoperative pain was performed using the VAS. It was explained that the closest score between "0" no pain and "10" severe pain scores should be recorded by the parents.
Measured: 48 hours
Postoperative Pain Assessments
Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 72nd hour was evaluated. All parents participating in the study were blinded to the treatment protocol used for the children. Evaluation of postoperative pain was performed using the VAS. It was explained that the closest score between "0" no pain and "10" severe pain scores should be recorded by the parents.
Measured: 72 hours
Postoperative Pain Assessments
Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 1st week was evaluated. All parents participating in the study were blinded to the treatment protocol used for the children. Evaluation of postoperative pain was performed using the VAS. It was explained that the closest score between "0" no pain and "10" severe pain scores should be recorded by the parents.
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Apr 2022
- Primary completion1 May 2022
- Study completion18 Jan 2023
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 Necmettin Erbakan 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Abakli Inci, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927025
- Sponsor's protocol ID
- NecmettinMA-001
- Status last verified
- Jun 2023
- First submitted
- 3 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research will be published soon.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different NiTi Rotary Files With NiTi Hand Files to Postoperative Pain Effects : A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05927025
- Acronym / sponsor ID
- NecmettinMA-001
- Conditions
- Postoperative Pain
- Keywords
- Root canal treatment, Nickel-Titanium instruments, Postoperative pain, Primary tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 3 Jul 2023 (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.
Root canal treatment is a treatment method in which the pulp is irreversibly infected due to caries or trauma or when the pulp loses its vitality. Biomechanical preparation of primary teeth is an important step for a successful root canal treatment. The success of root canal treatment depends not only on the biological results of the treatment, but also on minimizing the postoperative pain of the patients. Therefore, the elimination of factors associated with postoperative pain has an important role in the prognosis of patients after treatment. In all root canal preparation methods, some debris overflows from the apical. Debris protruding into the apical area causes postoperative pain. Many studies in the literature have shown that NiTi rotary files cause less extrusion of debris compared to hand files, and therefore less postoperative pain. Within the scope of this study, the effect of NiTi K hand file and WaveOne Gold, ProTaper Next, EndoArt NiTi Pedo Gold file, AF Baby rotary file systems on postoperative pain in root canal treatment preparations applied to the mandibular primary molar teeth of pediatric patients aged 5-8 years. It is intended to be evaluated using VAS).
In our research; ProTaper Next (PTN), WaveOne Gold (WOG), AF Baby rotary file, EndoArt NiTi Pedo Gold file, NiTi K type hand files were used. 100 patients between the ages of 5 and 8 who had root canal treatment indications for mandibular primary second molars were included in the study. The patients were divided into 5 groups with 20 patients in each group. All systems were used according to the manufacturer's instructions and all treatments were performed by a single operator in a single session. Postoperative pain was recorded using the Visual Analog Scale (VAS) at the 6th, 12th, 18th, 24th, 48th, 72nd hour and 1st week following treatment. The obtained data were evaluated statistically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Hand K-files | Experimental | Procedure: Hand K-filesNiTi K type hand file (Perfect Medical Instrument Co., Ltd. Shenzhen, China), Contrary to stainless steel files, turning is produced with the buckling method. torsional resistance and bending resistance of files compared to stainless steel files found more successful in comparison. 16 mm of the files are finished It has the edge. Our Work is 25mm long; 15K (white), 20K (yellow), 25K (red), 30 K (blue) files were used. NiTi K type #15, #20, #25, and #30 hand files were used with a quarter-turn pulling motion, respectively. |
| ProTaper Next | Experimental | Procedure: Hand K-filesThe ProTaper Next (PTN) system is produced by adding M-Wire alloy to the ProTaper Universal (PU) system. With the M-Wire alloy, it is aimed to increase the flexibility and cyclic fatigue resistance of the files. The combination of three important design features in PTN files, including changing taper on a single file, M-wire technology and offset design, is one of the important features that distinguish it from other files. PTN X1 and X2 files have both an ascending and a descending conical design on a single file; PTN X3, X4 and X5 files have a constant taper from D1-D3, then taper design that tapers off over the rest of their active segments. |
| WaveOne Gold | Experimental | Procedure: Hand K-filesThey are produced by applying Gold-wire process to the WaveOne (WO) system. The WOG file system exhibits repetitive back-and-forth mutual 'reciprocation' motion during preparation, in contrast to the continuous rotational motion. While rotating 150° counterclockwise during the reciprocating motion, clockwise It turns 30° in the direction of, and after 3 cycles, it completes 1 full cycle. Thus, it contributed positively to the file reaching the apical without applying excessive pressure, increasing the cutting efficiency, and accelerating the coronal movement of the debris. Small (yellow-20/0.07), WO Primary (red-25/0.07), and WOG Medium (green-35/0.06) files were used with the appropriate speed and torque values recommended by the manufacturer (300 rpm and 2.0 Ncm) by applying crown down technique. WOG files were operated in a reciprocating motion (150° counterclockwise, 30° clockwise). |
| AF Baby Rotary File | Experimental | Procedure: Hand K-filesAF Baby rotary file is specially designed for milk teeth. Entry file 11 mm other the files are 16 mm long and consist of 4 different rotary instruments; (17/.08), (20/.04), (25/.04) and (30/.04).The cross-sections of the files are triangular and heat treatment is applied to the NiTi wire. produced as a result. Thus, an increase in resistance to cyclic fatigue and an increase in dentin It is aimed to reduce screwing. Root canal thanks to its flexibility It adapts very well to the curvatures in its anatomy. AF Baby rotary files #20, #25, and #30 were used with the crown down technique with the appropriate speed and torque values (350 rpm and 2.0 Ncm) recommended by the manufacturer. |
| EndoArt NiTi Pedo Golf File | Experimental | Procedure: Hand K-filesEndoArt NiTi Pedo Gold file is specially designed for primary teeth. 18mm length consists of 4 different rotary tools: (15/06) white, (20/04) yellow, (25/04) red, (30/04) blue. The cross-sections of the files are triangular, and Gold wire technology is used in the production phase. were produced using Thus, a titanium oxide layer on the surface of the instrument Happened. Thus, it is more flexible and more flexible than conventional NiTi alloys. resistant and 2 times better cyclic fatigue resistance than conventional files exists. EndoArt NiTi Pedo Golf File; EndoArt NiTi Pedo Gold #15, #20, and #30 files were used with the crown down technique with the appropriate speed and torque values recommended by the manufacturer (350 rpm and 2.0 Ncm). |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- No analgesic use 12 hours before root canal treatment
- No systemic disease.
- Teeth with a diagnosis of irreversible pulpitis, no other teeth causing pain at the site of the tooth to be treated, no inter-root bone loss exceeding 1/3, and root canal inclinations of no more than 25° according to Schneider method were included in the study.
Key exclusion criteria (2 listed)
- Patients with post-procedural analgesic use were excluded from the study
- Patients whose parents did not fully understand the instructions and who did not attend the follow-up visit one week after treatment were excluded.
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 |
|---|---|---|
| Hand K-filesAlso: ProTaper Next, WaveOne Gold, AF Baby Rotary File, EndoArt NiTi Pedo Golf FileIt is used for cleaning and shaping root canals. | Procedure or surgery | AF Baby Rotary File, EndoArt NiTi Pedo Golf File, Hand K-files, ProTaper Next, WaveOne Gold |
Primary outcome
Postoperative Pain Assessments
Time frame: 6 hours
Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 6th hour was evaluated. All parents participating in the study were blinded to the treatment protocol used for the children. Evaluation of postoperative pain was performed using the VAS . It was explained that the closest score between "0" no pain and "10" severe pain scores should be recorded by the parents.
Postoperative Pain Assessments
Time frame: 12 hours
Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 12th hour was evaluated. All parents participating in the study were blinded to the treatment protocol used for the children. Evaluation of postoperative pain was performed using the VAS. It was explained that the closest score between "0" no pain and "10" severe pain scores should be recorded by the parents.
Postoperative Pain Assessments
Time frame: 24 hours
Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 24th hour was evaluated. All parents participating in the study were blinded to the treatment protocol used for the children. Evaluation of postoperative pain was performed using the VAS. It was explained that the closest score between "0" no pain and "10" severe pain scores should be recorded by the parents.
Postoperative Pain Assessments
Time frame: 48 hours
Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 48th hour was evaluated. All parents participating in the study were blinded to the treatment protocol used for the children. Evaluation of postoperative pain was performed using the VAS. It was explained that the closest score between "0" no pain and "10" severe pain scores should be recorded by the parents.
Postoperative Pain Assessments
Time frame: 72 hours
Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 72nd hour was evaluated. All parents participating in the study were blinded to the treatment protocol used for the children. Evaluation of postoperative pain was performed using the VAS. It was explained that the closest score between "0" no pain and "10" severe pain scores should be recorded by the parents.
Postoperative Pain Assessments
Time frame: 1 weeks
Evaluation of the effect on pain after root canal treatment; Parents were trained to use the pain scale; Postoperative pain occurring at the 1st week was evaluated. All parents participating in the study were blinded to the treatment protocol used for the children. Evaluation of postoperative pain was performed using the VAS. It was explained that the closest score between "0" no pain and "10" severe pain scores should be recorded by the parents.
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 3 Jul 2023.
- Individual participant dataSharing planned: No. The research will be published soon.
Related trials for Postoperative Pain
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
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 Hand K-files in people with Postoperative Pain, run by Necmettin Erbakan 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 2 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 3 Jul 2023. 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 Assessments (time frame: 6 hours). The study lists 6 primary outcomes in all. 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 3 Jul 2023.