Pulpitis - IrreversibleNCT02952300
Post Operative Pain of Root Canal Preparation With Wave One and Neolix in Acute Irreversible Pulpitis
A study testing neolix and wave one in people with Pulpitis - Irreversible, run by Cairo University.
Trial summary
the aim in this prospective in vivo randomized clinical trial to evaluate the influence of instrumentation technique ( reciprocation single file (wave one ) versus rotation single file (neolix) ) on post operative pain ( incidence ,degree and duration ) after endodontic treatment in single rooted lower premolars with… Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- neolix and wave one
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients in good health(American Society of Anesthesiologists Class II or higher).
- Patients having symptomatic irreversible pulpitis in one of their mandibular premolars.
- Age range is between 20 and 35 years.
- Patients who can understand numerical rating scale (NRS).
- Patients able to sign informed consent.
Who cannot join
- Patients with positive percussion test .
- Patients having history of necrosis with or without apical pathosis .
- Patients have sinus tract or fistula extraoral or intraoral.
- Patients having active pain in more than one pre molar.
- Patients who had taken analgesics in the 12 hours preceding the preparation.
- Pregnant or mentally retarded patients.
- Teeth with grade 2 or 3 mobility.
Trial locations and contacts
No sites are listed yet.
alaa elbaz, ass. professor contact
About this study
Official title: Comparative Evaluation of Postoperative Pain After Root Canal Preparation With Wave One and Neolix in Acute Irreversible Pulpitis of Mandibular Premolar Teeth
the aim in this prospective in vivo randomized clinical trial to evaluate the influence of instrumentation technique ( reciprocation single file (wave one ) versus rotation single file (neolix) ) on post operative pain ( incidence ,degree and duration ) after endodontic treatment in single rooted lower premolars with symptomatic irreversible pulpits.
According to the inclusion criteria the patients enrolled in the study and allocated randomly into two groups either Wave One (group A) or Neolix ( group B) the endodontic treatment is done at single visit. firstly the patient's medical and dental history is taken .the patient assign on informed consent. and then,anaesthetized and access cavity performed and root canal preparation is done by either two systems and then irrigation and obturation is done. the patient record the post operative pain in sheet with NRS after 6,12,24,48hr and the operator will recall the patient to check the records and follow up the patient.
Read the detailed description
Medical and dental history: diagnostic charts will be collected in a case report form by the investigators and confirmed for eligibility with the assistant supervisor.
Radiographic examination : preoperative radiographs will be taken to examine the tooth structure,caries detection , periapical status .
Clinical examination : intraoral examination include visual examination for caries , restoration ,swelling ,fistula . mobility, percussion were done .
Diagnostic criteria for symptomatic irreversible pulpitis:
- The patient marks moderate to severe pain on the numerical rating scale (NRS) . a horizontal line of 11 marks and 10 intervals each takes numbers from 0 to 10 where 0 = no pain , 1-3 =mild pain , 4-6 = moderate pain , 7-10 = severe pain (recording the baseline degree of pain preoperatively before initiating the endodontic treatment ) all the steps done by the same operator.
- The patient shows severe pain which lasts long after thermal testing which is done by applying hot compound stick on the tooth after coating it with a lubricant.
- The patient responds to electric pulp tester at a lower level than the contralateral tooth or the adjacent tooth if the contralateral one is missing.
Intervention:
Forty four patients will included and they will be randomly divided into two groups A =root canal preparation with single reciprocating file (Wave One ® Dentsply , Switzerland) and B = Root canal preparation with single full rotation file (Neolix ® Neolix ,France) each group consisted from 22 patient .
Procedure steps :
- Patients are asked to rate their pain level on numerical rating scale before the anesthesia injection and the start of the preparation to get the baseline record for the pain preoperatively .
- The patient will receive inferior alveolar nerve block injections ( 1.8 ml mepivacaine hydrochloride 2% ( 1: 100,000 epinephrine ) using a side loading aspirating syringe and 27-gauge long needle.
- At 15-minutes post injection, access cavity is performed using round bur size 4 and endo-z bur.
- Tooth is then isolated using rubber dam to prevent introduction of saliva and Bactria from the oral cavity .
- Checking the patency of the canal with K- file (Mani Inc., Japan). size 10 taper 0.02, extirpation of pulp with H-file (Mani Inc., Japan). size 15 taper 0.02 .
- An electronic apex locator ( Morita Corporation, Kyoto, Japan) will be used to determine working length, and then working length will be confirmed radiographically to be adjusted 1mm shorter that the root apex.
- Each patient has equal chance to enter either the intervention groups A or B group as each patient takes number in excel sheet divided into two groups A and B chosen by assistant supervisor who determine which system will be used with this patient .
- Comparator group: If the system to by used is Wave One the canal preparation is done by primary file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani Inc., Japan) is passively fit in the canal ( most of canals ) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large large file size 40 taper 8% either of them to the full working length with pre programmed motor (X-Smart Plus (Dentsply) with reducing hand piece 6:1 more anticlockwise angle than clock wise one .
- Experimental group : If the Neolix systems will be used ,then the first file used is C1 file size 25 taper 12% as orifice opener and for coronal flaring for 2/3 of canal length the A1 file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani Inc., Japan). is passively fit in the canal (most of the canals) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large file size 40 taper 4% either of them to the full working length to the full working length with X-Smart Plus motor with speed 300-500 rpm and torque 1.5 N.cm.
- Irrigation is made between each file using 2.5% sodium hypochlorite and MD-ChelCream19% ethylenediaminetetraacetic acid cream (METABIOMED company , Korea).
- The canals are then dried with paper points and obturated with gutta percha and ADSEAL resin sealer(METABIOMED company, Korea) by selection of a master cone corresponding to the size of master apical file, then spreader will be selected to provide auxiliary cones using cold lateral compaction technique.
- Access cavity is then sealed with temporary filling.
- then rating of post operative pain after the treatment is recorded by numerical rating scale ( NRS) in sheet given to the patient to record the degree of pain after 6 hrs ,12 hrs ,24 hrs ,48 hrs together with recalling the patient to check the record then the patient return the sheet to the operator and then the collected sheets presented to assistant supervisor.
- Conditions
- Pulpitis - Irreversible
- Being tested
- neolix, wave one
- Keywords
- irreversible pulpitis, reciprocation, rotation, single file, wave one, neolix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neolixProcedure or surgery
single rotation file
wave oneProcedure or surgery
single reciprocation file
| Study group | Role | What they receive |
|---|---|---|
| neolix | Experimental | single full rotation file (Neolix ® Neolix ,France) the first file used is C1 file size 25 taper 12% as orifice opener and for coronal flaring for 2/3 of canal length the A1 file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani Inc., Japan). is passively fit in the canal (most of the canals) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large file size 40 taper 4% either of them to the full working length of the canal Receives: Procedure: neolix |
| wave one | Active comparator | single reciprocating file (Wave One ® Dentsply , Switzerland) the canal preparation is done by primary file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani Inc., Japan) is passively fit in the canal ( most of canals ) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large large file size 40 taper 8% either of them to the full working length of the canal Receives: Procedure: wave one |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
intensity of postoperative pain after treatment by Numerical Rating Scale (0-10)
Measured: up to 48 hours after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionOct 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulpitis - IrreversibleStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin hassan youseif, Cairo University
- Investigators
- abeer marouzk, professor, Study chair, faculty of oral and dental medicine -cairo universityalaa el baz, ass. professor, Study director, faculty of oral and dental medicine -cairo universityyasmin hassan yousief, resident, Principal investigator, faculty of oral and dental medicine -cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952300
- Sponsor's protocol ID
- CEBC-CU-2016-10-146
- Status last verified
- Nov 2016
- First submitted
- 31 Oct 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J. 2008 Feb;41(2):91-9. doi: 10.1111/j.1365-2591.2007.01316.x. Epub 2007 Oct 23.
PubMed 17956561Tanalp J, Kaptan F, Sert S, Kayahan B, Bayirl G. Quantitative evaluation of the amount of apically extruded debris using 3 different rotary instrumentation systems. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Feb;101(2):250-7. doi: 10.1016/j.tripleo.2005.03.002. Epub 2005 Oct 14.
PubMed 16448929Nekoofar MH, Sadeghipanah M, Dehpour AR. Evaluation of meloxicam (A cox-2 inhibitor) for management of postoperative endodontic pain: a double-blind placebo-controlled study. J Endod. 2003 Oct;29(10):634-7. doi: 10.1097/00004770-200310000-00005.
PubMed 14606784Pochapski MT, Santos FA, de Andrade ED, Sydney GB. Effect of pretreatment dexamethasone on postendodontic pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Nov;108(5):790-5. doi: 10.1016/j.tripleo.2009.05.014. Epub 2009 Sep 12.
PubMed 19748294Ince B, Ercan E, Dalli M, Dulgergil CT, Zorba YO, Colak H. Incidence of postoperative pain after single- and multi-visit endodontic treatment in teeth with vital and non-vital pulp. Eur J Dent. 2009 Oct;3(4):273-9.
PubMed 19826598Pak JG, White SN. Pain prevalence and severity before, during, and after root canal treatment: a systematic review. J Endod. 2011 Apr;37(4):429-38. doi: 10.1016/j.joen.2010.12.016.
PubMed 21419285
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Postoperative Pain After Root Canal Preparation With Wave One and Neolix in Acute Irreversible Pulpitis of Mandibular Premolar Teeth
- ClinicalTrials.gov ID
- NCT02952300
- Acronym / sponsor ID
- CEBC-CU-2016-10-146
- Conditions
- Pulpitis - Irreversible
- Keywords
- irreversible pulpitis, reciprocation, rotation, single file, wave one, neolix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 2 Nov 2016 (estimated)
- 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 in this prospective in vivo randomized clinical trial to evaluate the influence of instrumentation technique ( reciprocation single file (wave one ) versus rotation single file (neolix) ) on post operative pain ( incidence ,degree and duration ) after endodontic treatment in single rooted lower premolars with symptomatic irreversible pulpits.
According to the inclusion criteria the patients enrolled in the study and allocated randomly into two groups either Wave One (group A) or Neolix ( group B) the endodontic treatment is done at single visit. firstly the patient's medical and dental history is taken .the patient assign on informed consent. and then,anaesthetized and access cavity performed and root canal preparation is done by either two systems and then irrigation and obturation is done. the patient record the post operative pain in sheet with NRS after 6,12,24,48hr and the operator will recall the patient to check the records and follow up the patient.
Detailed description
Medical and dental history: diagnostic charts will be collected in a case report form by the investigators and confirmed for eligibility with the assistant supervisor.
Radiographic examination : preoperative radiographs will be taken to examine the tooth structure,caries detection , periapical status .
Clinical examination : intraoral examination include visual examination for caries , restoration ,swelling ,fistula . mobility, percussion were done .
Diagnostic criteria for symptomatic irreversible pulpitis:
- The patient marks moderate to severe pain on the numerical rating scale (NRS) . a horizontal line of 11 marks and 10 intervals each takes numbers from 0 to 10 where 0 = no pain , 1-3 =mild pain , 4-6 = moderate pain , 7-10 = severe pain (recording the baseline degree of pain preoperatively before initiating the endodontic treatment ) all the steps done by the same operator.
- The patient shows severe pain which lasts long after thermal testing which is done by applying hot compound stick on the tooth after coating it with a lubricant.
- The patient responds to electric pulp tester at a lower level than the contralateral tooth or the adjacent tooth if the contralateral one is missing.
Intervention:
Forty four patients will included and they will be randomly divided into two groups A =root canal preparation with single reciprocating file (Wave One ® Dentsply , Switzerland) and B = Root canal preparation with single full rotation file (Neolix ® Neolix ,France) each group consisted from 22 patient .
Procedure steps :
- Patients are asked to rate their pain level on numerical rating scale before the anesthesia injection and the start of the preparation to get the baseline record for the pain preoperatively .
- The patient will receive inferior alveolar nerve block injections ( 1.8 ml mepivacaine hydrochloride 2% ( 1: 100,000 epinephrine ) using a side loading aspirating syringe and 27-gauge long needle.
- At 15-minutes post injection, access cavity is performed using round bur size 4 and endo-z bur.
- Tooth is then isolated using rubber dam to prevent introduction of saliva and Bactria from the oral cavity .
- Checking the patency of the canal with K- file (Mani Inc., Japan). size 10 taper 0.02, extirpation of pulp with H-file (Mani Inc., Japan). size 15 taper 0.02 .
- An electronic apex locator ( Morita Corporation, Kyoto, Japan) will be used to determine working length, and then working length will be confirmed radiographically to be adjusted 1mm shorter that the root apex.
- Each patient has equal chance to enter either the intervention groups A or B group as each patient takes number in excel sheet divided into two groups A and B chosen by assistant supervisor who determine which system will be used with this patient .
- Comparator group: If the system to by used is Wave One the canal preparation is done by primary file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani Inc., Japan) is passively fit in the canal ( most of canals ) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large large file size 40 taper 8% either of them to the full working length with pre programmed motor (X-Smart Plus (Dentsply) with reducing hand piece 6:1 more anticlockwise angle than clock wise one .
- Experimental group : If the Neolix systems will be used ,then the first file used is C1 file size 25 taper 12% as orifice opener and for coronal flaring for 2/3 of canal length the A1 file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani Inc., Japan). is passively fit in the canal (most of the canals) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large file size 40 taper 4% either of them to the full working length to the full working length with X-Smart Plus motor with speed 300-500 rpm and torque 1.5 N.cm.
- Irrigation is made between each file using 2.5% sodium hypochlorite and MD-ChelCream19% ethylenediaminetetraacetic acid cream (METABIOMED company , Korea).
- The canals are then dried with paper points and obturated with gutta percha and ADSEAL resin sealer(METABIOMED company, Korea) by selection of a master cone corresponding to the size of master apical file, then spreader will be selected to provide auxiliary cones using cold lateral compaction technique.
- Access cavity is then sealed with temporary filling.
- then rating of post operative pain after the treatment is recorded by numerical rating scale ( NRS) in sheet given to the patient to record the degree of pain after 6 hrs ,12 hrs ,24 hrs ,48 hrs together with recalling the patient to check the record then the patient return the sheet to the operator and then the collected sheets presented to assistant supervisor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neolix | Experimental | Procedure: neolixsingle full rotation file (Neolix ® Neolix ,France) the first file used is C1 file size 25 taper 12% as orifice opener and for coronal flaring for 2/3 of canal length the A1 file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani Inc., Japan). is passively fit in the canal (most of the canals) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large file size 40 taper 4% either of them to the full working length of the canal |
| wave one | Active comparator | Procedure: wave onesingle reciprocating file (Wave One ® Dentsply , Switzerland) the canal preparation is done by primary file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani Inc., Japan) is passively fit in the canal ( most of canals ) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large large file size 40 taper 8% either of them to the full working length of the canal |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients in good health(American Society of Anesthesiologists Class II or higher).
- Patients having symptomatic irreversible pulpitis in one of their mandibular premolars.
- Age range is between 20 and 35 years.
- Patients who can understand numerical rating scale (NRS).
- Patients able to sign informed consent.
Key exclusion criteria (7 listed)
- Patients with positive percussion test .
- Patients having history of necrosis with or without apical pathosis .
- Patients have sinus tract or fistula extraoral or intraoral.
- Patients having active pain in more than one pre molar.
- Patients who had taken analgesics in the 12 hours preceding the preparation.
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 |
|---|---|---|
| neolixsingle rotation file | Procedure or surgery | neolix |
| wave onesingle reciprocation file | Procedure or surgery | wave one |
Primary outcome
postoperative pain
Time frame: up to 48 hours after completion of treatment
intensity of postoperative pain after treatment by Numerical Rating Scale (0-10)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Background: PubMed 17956561Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J. 2008 Feb;41(2):91-9. doi: 10.1111/j.1365-2591.2007.01316.x. Epub 2007 Oct 23.
- Background: PubMed 16448929Tanalp J, Kaptan F, Sert S, Kayahan B, Bayirl G. Quantitative evaluation of the amount of apically extruded debris using 3 different rotary instrumentation systems. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Feb;101(2):250-7. doi: 10.1016/j.tripleo.2005.03.002. Epub 2005 Oct 14.
- Background: PubMed 14606784Nekoofar MH, Sadeghipanah M, Dehpour AR. Evaluation of meloxicam (A cox-2 inhibitor) for management of postoperative endodontic pain: a double-blind placebo-controlled study. J Endod. 2003 Oct;29(10):634-7. doi: 10.1097/00004770-200310000-00005.
- Background: PubMed 19748294Pochapski MT, Santos FA, de Andrade ED, Sydney GB. Effect of pretreatment dexamethasone on postendodontic pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Nov;108(5):790-5. doi: 10.1016/j.tripleo.2009.05.014. Epub 2009 Sep 12.
- Background: PubMed 19826598Ince B, Ercan E, Dalli M, Dulgergil CT, Zorba YO, Colak H. Incidence of postoperative pain after single- and multi-visit endodontic treatment in teeth with vital and non-vital pulp. Eur J Dent. 2009 Oct;3(4):273-9.
- Background: PubMed 21419285Pak JG, White SN. Pain prevalence and severity before, during, and after root canal treatment: a systematic review. J Endod. 2011 Apr;37(4):429-38. doi: 10.1016/j.joen.2010.12.016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
alaa elbaz, ass. professor contact
abeer marouzk, professor study chair
faculty of oral and dental medicine -cairo university
alaa el baz, ass. professor study director
faculty of oral and dental medicine -cairo university
yasmin hassan yousief, resident principal investigator
faculty of oral and dental medicine -cairo university
Questions about this trial
What is this clinical trial studying?
A study testing neolix and wave one in people with Pulpitis - Irreversible, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yasmin hassan yousief, resident (01146326683, dr.yasmien90@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: up to 48 hours after completion of treatment). 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 NCT02952300, which also lists 6 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 2 Nov 2016.