Postoperative PainNCT04559438
Post-operative Pain Following Glide Path Preparation Using Rotary Neoniti GPS File and Manual K-files
A study testing Rotary Neoniti GPS file and Manual stainless steel K-files in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to clinically compare the incidence of post-operative pain after using rotary glide path file (Neoniti GPS), on post-operative pain when compared to manual glide path preparation in lower molars with asymptomatic non-vital pulp. 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?
- Rotary Neoniti GPS file and Manual stainless steel K-files
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Apr 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
- Systemically healthy patients (ASA I or II)
- Lower permanent molar teeth with:
- Asymptomatic non-vital pulps, No response of pulp tissue to cold pulp tester (ethyl chloride spray), with or without periapical lesions.
Who cannot join
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- History of intolerance to NSAIDS.
- Patients with two or more adjacent teeth requiring endodontic treatment.
- TMJ problems, bruxism, clenching or traumatic occlusion.
- Inability to perceive the given instructions.
- Teeth with:
- Vital pulp tissues. Association with swelling. Acute periapical abscess. Mobility Grade II or III. Pocket depth more than 5mm. Previous root canal therapy. Non-restorability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-operative Pain Following Glide Path Preparation Using Rotary Neoniti GPS File and Manual K-files in Non-vital Lower Molars: A Randomized Controlled Trial
The aim of this study is to clinically compare the incidence of post-operative pain after using rotary glide path file (Neoniti GPS), on post-operative pain when compared to manual glide path preparation in lower molars with asymptomatic non-vital pulp.
- Conditions
- Postoperative Pain
- Being tested
- Rotary Neoniti GPS file, Manual stainless steel K-files
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotary Neoniti GPS fileOther
Glide path creation will be achieved using Neoniti GPS file (15/.03). The file will be introduced passively inside the canal, in continuous rotation at a constant speed between 300 and 500 rpm and torque of 1.5 N.
Manual stainless steel K-filesOther
Glide path preparation will be done by hand instrumentation using K-files #10 and 15.
| Study group | Role | What they receive |
|---|---|---|
| Rotary Neoniti GPS | Experimental | Glide path preparation using Rotary Neoniti GPS file (Neolix, châtres-la-Forêt, France). Receives: Other: Rotary Neoniti GPS file |
| Stainless steel K-files | Active comparator | Glide path preparation using manual stainless steel K-files #10, #15 (Dentsply Maillefer, Ballaigues, Switzerland). Receives: Other: Manual stainless steel K-files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain assessed using the Visual Analogue Scale
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Measured: 6 hours post treatment.
Postoperative pain assessed using the Visual Analogue Scale
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Measured: 12 hours post-treatment.
Postoperative pain assessed using the Visual Analogue Scale
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Measured: 24 hours post-treatment.
Postoperative pain assessed using the Visual Analogue Scale
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Measured: 48 hours post-treatment.
Postoperative pain assessed using the Visual Analogue Scale
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Measured: 72 hours post treatment.
Secondary outcomes (1)
Number of analgesic tablets taken by the patient
Number of analgesic tablets taken by the patient after root canal treatment.
Measured: Up to 72 hours post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Jan 2021
- Primary completion1 Oct 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engy Abdel Nour Atallah, Cairo University
- Investigators
- Heba ElFar, Professor, Study chair, Cairo University (Endodontics Department)Dina Morsy, Lecturer, Study director, Cairo University (Endodontics Department)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559438
- Sponsor's protocol ID
- ENDO 3-3-5
- Status last verified
- Feb 2023
- First submitted
- 10 Sep 2020
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pasqualini D, Mollo L, Scotti N, Cantatore G, Castellucci A, Migliaretti G, Berutti E. Postoperative pain after manual and mechanical glide path: a randomized clinical trial. J Endod. 2012 Jan;38(1):32-6. doi: 10.1016/j.joen.2011.09.017. Epub 2011 Oct 27.
PubMed 22152616Keskin C, Sivas Yilmaz O, Inan U, Ozdemir O. Postoperative pain after glide path preparation using manual, reciprocating and continuous rotary instruments: a randomized clinical trial. Int Endod J. 2019 May;52(5):579-587. doi: 10.1111/iej.13053. Epub 2018 Dec 31.
PubMed 30536837West JD. The endodontic Glidepath: "Secret to rotary safety". Dent Today. 2010 Sep;29(9):86, 88, 90-3.
PubMed 20973422
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Pain Following Glide Path Preparation Using Rotary Neoniti GPS File and Manual K-files in Non-vital Lower Molars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04559438
- Acronym / sponsor ID
- ENDO 3-3-5
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to clinically compare the incidence of post-operative pain after using rotary glide path file (Neoniti GPS), on post-operative pain when compared to manual glide path preparation in lower molars with asymptomatic non-vital pulp.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotary Neoniti GPS | Experimental | Other: Rotary Neoniti GPS fileGlide path preparation using Rotary Neoniti GPS file (Neolix, châtres-la-Forêt, France). |
| Stainless steel K-files | Active comparator | Other: Manual stainless steel K-filesGlide path preparation using manual stainless steel K-files #10, #15 (Dentsply Maillefer, Ballaigues, Switzerland). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Systemically healthy patients (ASA I or II)
- Lower permanent molar teeth with:
- Asymptomatic non-vital pulps, No response of pulp tissue to cold pulp tester (ethyl chloride spray), with or without periapical lesions.
Key exclusion criteria (7 listed)
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- History of intolerance to NSAIDS.
- Patients with two or more adjacent teeth requiring endodontic treatment.
- TMJ problems, bruxism, clenching or traumatic occlusion.
- Inability to perceive the given instructions.
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 |
|---|---|---|
| Rotary Neoniti GPS fileGlide path creation will be achieved using Neoniti GPS file (15/.03). The file will be introduced passively inside the canal, in continuous rotation at a constant speed between 300 and 500 rpm and torque of 1.5 N. | Other | Rotary Neoniti GPS |
| Manual stainless steel K-filesGlide path preparation will be done by hand instrumentation using K-files #10 and 15. | Other | Stainless steel K-files |
Primary outcome
Postoperative pain assessed using the Visual Analogue Scale
Time frame: 6 hours post treatment.
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Postoperative pain assessed using the Visual Analogue Scale
Time frame: 12 hours post-treatment.
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Postoperative pain assessed using the Visual Analogue Scale
Time frame: 24 hours post-treatment.
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Postoperative pain assessed using the Visual Analogue Scale
Time frame: 48 hours post-treatment.
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Postoperative pain assessed using the Visual Analogue Scale
Time frame: 72 hours post treatment.
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
1 secondary outcome
Number of analgesic tablets taken by the patient
Time frame: Up to 72 hours post treatment.
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 6 Feb 2023.
- Background: PubMed 22152616Pasqualini D, Mollo L, Scotti N, Cantatore G, Castellucci A, Migliaretti G, Berutti E. Postoperative pain after manual and mechanical glide path: a randomized clinical trial. J Endod. 2012 Jan;38(1):32-6. doi: 10.1016/j.joen.2011.09.017. Epub 2011 Oct 27.
- Background: PubMed 30536837Keskin C, Sivas Yilmaz O, Inan U, Ozdemir O. Postoperative pain after glide path preparation using manual, reciprocating and continuous rotary instruments: a randomized clinical trial. Int Endod J. 2019 May;52(5):579-587. doi: 10.1111/iej.13053. Epub 2018 Dec 31.
- Background: PubMed 20973422West JD. The endodontic Glidepath: "Secret to rotary safety". Dent Today. 2010 Sep;29(9):86, 88, 90-3.
- Individual participant dataSharing planned: Undecided
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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.
Heba ElFar, Professor study chair
Cairo University (Endodontics Department)
Dina Morsy, Lecturer study director
Cairo University (Endodontics Department)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotary Neoniti GPS file and Manual stainless steel K-files in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 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 Egypt. 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 assessed using the Visual Analogue Scale (time frame: 6 hours post treatment.). The study lists 5 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 NCT04559438, which also lists 3 linked publications.
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 6 Feb 2023.