Post Operative PainNCT05955742
Postoperative Pain After Using Different Single-File Glide Path Systems
A study testing ProGlider and WaveOne Gold Glider in people with Post Operative Pain, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate postoperative pain intensity after glide-path preparation with the ProGlider (PG) and WaveOne Gold Glider (WOGG) systems in asymptomatic teeth with necrotic pulp and periapical lesions.Maxillary and mandibular molars with chronic apical periodontitis of 78 patients (age, 18-65 years) were… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- ProGlider and WaveOne Gold Glider
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jun 2019to 15 Sep 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic maxillary and mandibular first and second molars diagnosed with chronic apical periodontitis in healthy patients
- Patients between 18-65 years old
- Patients who had not taken antidepressants, sedative drugs, analgesics and/or anti-inflammatory drugs
- Patients who could understand the use of numeric rating scale (NRS) for pain.
Who cannot join
- Patients who were allergic to anesthetics and non-steroidal drugs
- Patients who use immunosuppressants
- Patients who are pregnant or breastfeeding
- Patients with systemic infections.
- Teeth with advanced periodontal disease
- Teeth with acute pain
Show all 12Show fewer
- Teeth with calcified or resorbed canals
- Teeth with complex root canal anatomy
- Teeth with vital pulp
- Unrestorable teeth
- Presence of cracks and/or fractures
- Teeth associated with acute and chronic apical abscesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Postoperative Pain After Using Different Single-File Glide Path Systems: a Randomized Clinical Trial
This study aimed to evaluate postoperative pain intensity after glide-path preparation with the ProGlider (PG) and WaveOne Gold Glider (WOGG) systems in asymptomatic teeth with necrotic pulp and periapical lesions.Maxillary and mandibular molars with chronic apical periodontitis of 78 patients (age, 18-65 years) were included. The patients were randomly divided into three groups: control (n = 26), PG (n = 26), and WOGG (n = 26). All systems were used according to the manufacturer's instructions, and all root canal treatments were completed by a single operator within two sessions. Postoperative pain was assessed using a numerical rating scale (NRS) at 6, 12, 18, 24, 48, and 72 h. The intake of prescribed analgesics and abscess formation were also recorded.
Read the detailed description
Pain after root canal treatment is an important complication encountered in endodontic practice, with a reported prevalence of 3%-58%. Severe pain may start even 24 to 48 h after treatment. Postoperative pain has a complex etiology, including treatment factors under the control of the clinician, microbial factors related to the contents of infected root canals, patient demographic factors (patient sex and age, among others), immunological factors, local tissue changes, and psychological factors. Debris extrusion to the periapical tissues during root canal instrumentation can significantly influence the incidence and intensity of postoperative pain. The root canal instrumentation technique may play an important role in the occurrence of postoperative pain as it can induce an acute inflammatory response following periapical extrusion of necrotic tissues, infected debris, and bacteria. Previous clinical trials have evaluated the effect of reciprocation and continuous rotation kinematics on debris extrusion and postoperative pain; however, their results are conflicting.
The glide path is defined as a straight tunnel extending from the canal orifice to the physiological apical foramen. Glide-path preparation may prevent complications of root canal instrumentation; reduce risk of instrument failure, debris extrusion, and postoperative pain; and preserve root canal anatomy, thereby reducing the risk of transportation, perforation, and step and zip formation. Many NiTi glide-path file systems of different sizes and metallurgical properties have been introduced to date. Recently, a new single glide-path file system was introduced with the aim of reducing the number of files used and simplifying glide-path instrumentation.
The effect of glide-path file systems on postoperative pain has been studied previously. However, to the best of investigators' knowledge, there are no data comparing PG and WOGG glide-path files in terms of postoperative pain in asymptomatic teeth with necrotic pulp and periapical lesions. Therefore, the purpose of this in vivo study was to evaluate the incidence and intensity of postoperative pain in asymptomatic maxillary and mandibular molars with necrotic pulp and periapical lesions after glide-path preparation with a stainless-steel K-file and PG and WOGG glide-path file systems. The null hypothesis was that there is no difference in the incidence and intensity of postoperative pain between glide-path preparation techniques.
- Conditions
- Post Operative Pain
- Being tested
- Control, ProGlider, WaveOne Gold Glider
- Keywords
- chronic apical periodontitis, glide path preparation, Postoperative pain, ProGlider, WaveOne Gold Glider
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDevice
The operator prepared the glide path using a #15K-type stainless-steel hand file.
ProGliderDevice
The operator prepared the glide path using the ProGlider file.
WaveOne Gold GliderDevice
The operator prepared the glide path using the WaveOne Gold Glider file.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Glide path preparation with hand files. Receives: Device: Control |
| ProGlider | Experimental | Glide path preparation using rotational NiTi file. Receives: Device: ProGlider |
| WaveOne Gold Glider | Experimental | Glide path was preparation using reciprocating NiTi file. Receives: Device: WaveOne Gold Glider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity following the use of different glide path preparations
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Measured: 6th hour
Postoperative pain intensity following the use of different glide path preparations
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Measured: 12th hour
Postoperative pain intensity following the use of different glide path preparations
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Measured: 18th hour
Postoperative pain intensity following the use of different glide path preparations
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Measured: 24th hour
Postoperative pain intensity following the use of different glide path preparations
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Measured: 48th hour
Postoperative pain intensity following the use of different glide path preparations
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Measured: 72nd hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start27 Jun 2019
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
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 Post Operative 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
- Group 1: control Group 2: ProGlider Group 3: WaveOne Gold Glider
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Yesildal Yeter, Eskisehir Osmangazi University
- Investigators
- Kubra Yesildal Yeter, Assoc. Prof., Principal investigator, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955742
- Sponsor's protocol ID
- EskisehirOU-endodonti
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Danaci Z, Yeter KY. Evaluation of Pain Following the Use of Different Single-file Glide Path Systems: A Randomized Clinical Trial. J Endod. 2024 Feb;50(2):120-128. doi: 10.1016/j.joen.2023.10.017. Epub 2023 Nov 3.
PubMed 37924939
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Pain After Using Different Single-File Glide Path Systems: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05955742
- Acronym / sponsor ID
- EskisehirOU-endodonti
- Conditions
- Post Operative Pain
- Keywords
- chronic apical periodontitis, glide path preparation, Postoperative pain, ProGlider, WaveOne Gold Glider
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 21 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.
This study aimed to evaluate postoperative pain intensity after glide-path preparation with the ProGlider (PG) and WaveOne Gold Glider (WOGG) systems in asymptomatic teeth with necrotic pulp and periapical lesions.Maxillary and mandibular molars with chronic apical periodontitis of 78 patients (age, 18-65 years) were included. The patients were randomly divided into three groups: control (n = 26), PG (n = 26), and WOGG (n = 26). All systems were used according to the manufacturer's instructions, and all root canal treatments were completed by a single operator within two sessions. Postoperative pain was assessed using a numerical rating scale (NRS) at 6, 12, 18, 24, 48, and 72 h. The intake of prescribed analgesics and abscess formation were also recorded.
Detailed description
Pain after root canal treatment is an important complication encountered in endodontic practice, with a reported prevalence of 3%-58%. Severe pain may start even 24 to 48 h after treatment. Postoperative pain has a complex etiology, including treatment factors under the control of the clinician, microbial factors related to the contents of infected root canals, patient demographic factors (patient sex and age, among others), immunological factors, local tissue changes, and psychological factors. Debris extrusion to the periapical tissues during root canal instrumentation can significantly influence the incidence and intensity of postoperative pain. The root canal instrumentation technique may play an important role in the occurrence of postoperative pain as it can induce an acute inflammatory response following periapical extrusion of necrotic tissues, infected debris, and bacteria. Previous clinical trials have evaluated the effect of reciprocation and continuous rotation kinematics on debris extrusion and postoperative pain; however, their results are conflicting.
The glide path is defined as a straight tunnel extending from the canal orifice to the physiological apical foramen. Glide-path preparation may prevent complications of root canal instrumentation; reduce risk of instrument failure, debris extrusion, and postoperative pain; and preserve root canal anatomy, thereby reducing the risk of transportation, perforation, and step and zip formation. Many NiTi glide-path file systems of different sizes and metallurgical properties have been introduced to date. Recently, a new single glide-path file system was introduced with the aim of reducing the number of files used and simplifying glide-path instrumentation.
The effect of glide-path file systems on postoperative pain has been studied previously. However, to the best of investigators' knowledge, there are no data comparing PG and WOGG glide-path files in terms of postoperative pain in asymptomatic teeth with necrotic pulp and periapical lesions. Therefore, the purpose of this in vivo study was to evaluate the incidence and intensity of postoperative pain in asymptomatic maxillary and mandibular molars with necrotic pulp and periapical lesions after glide-path preparation with a stainless-steel K-file and PG and WOGG glide-path file systems. The null hypothesis was that there is no difference in the incidence and intensity of postoperative pain between glide-path preparation techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Group 1: control Group 2: ProGlider Group 3: WaveOne Gold Glider
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Device: ControlGlide path preparation with hand files. |
| ProGlider | Experimental | Device: ProGliderGlide path preparation using rotational NiTi file. |
| WaveOne Gold Glider | Experimental | Device: WaveOne Gold GliderGlide path was preparation using reciprocating NiTi file. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Asymptomatic maxillary and mandibular first and second molars diagnosed with chronic apical periodontitis in healthy patients
- Patients between 18-65 years old
- Patients who had not taken antidepressants, sedative drugs, analgesics and/or anti-inflammatory drugs
- Patients who could understand the use of numeric rating scale (NRS) for pain.
Key exclusion criteria (12 listed)
- Patients who were allergic to anesthetics and non-steroidal drugs
- Patients who use immunosuppressants
- Patients who are pregnant or breastfeeding
- Patients with systemic infections.
- Teeth with advanced 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 |
|---|---|---|
| ControlThe operator prepared the glide path using a #15K-type stainless-steel hand file. | Device | Control |
| ProGliderThe operator prepared the glide path using the ProGlider file. | Device | ProGlider |
| WaveOne Gold GliderThe operator prepared the glide path using the WaveOne Gold Glider file. | Device | WaveOne Gold Glider |
Primary outcome
Postoperative pain intensity following the use of different glide path preparations
Time frame: 6th hour
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Postoperative pain intensity following the use of different glide path preparations
Time frame: 12th hour
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Postoperative pain intensity following the use of different glide path preparations
Time frame: 18th hour
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Postoperative pain intensity following the use of different glide path preparations
Time frame: 24th hour
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Postoperative pain intensity following the use of different glide path preparations
Time frame: 48th hour
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Postoperative pain intensity following the use of different glide path preparations
Time frame: 72nd hour
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
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 21 Jul 2023.
- Derived from this study: PubMed 37924939Danaci Z, Yeter KY. Evaluation of Pain Following the Use of Different Single-file Glide Path Systems: A Randomized Clinical Trial. J Endod. 2024 Feb;50(2):120-128. doi: 10.1016/j.joen.2023.10.017. Epub 2023 Nov 3.
- Individual participant dataSharing planned: No
Related trials for Post Operative Pain
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
RecruitingPhase 2/3
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Pain, Postoperative
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Active, not recruiting
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
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.
Kubra Yesildal Yeter, Assoc. Prof. principal investigator
Eskisehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProGlider and WaveOne Gold Glider in people with Post Operative Pain, run by Eskisehir Osmangazi 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 4 inclusion and 12 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 21 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 intensity following the use of different glide path preparations (time frame: 6th hour). 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?
On the ClinicalTrials.gov record for NCT05955742, 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 21 Jul 2023.