Symptomatic Irreversible PulpitisRCTNCT03096587
Effect Of XP Endo Finisher Versus Ultrasonic Activated Irrigation On Post-operative Pain In Endodontic Treatment of Symptomatic Irreversible Pulpitis
A study testing XP Endo Finisher and ultrasonic activated irrigation in people with Symptomatic Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
Recruited patients with symptomatic irreversible pulpitis are assigned to interventional (XP Endo Finisher file) and control group(ultrasonic activated irrigation) to undergo single visit endodontic treatment and record postoperative pain afterwards. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- XP Endo Finisher and ultrasonic activated irrigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2017to Apr 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically- free of any systemic disease
- Male or female
- Patients with age range 25-45
- Symptomatic irreversible pulpitis in single rooted single canal teeth without apical periodontitis.
- Teeth with mature root
- Restorable teeth
Show all 11Show fewer
- Teeth without calcified root canals
- Teeth without root caries
- Teeth without internal or external root resorption
- Teeth with no sign of crack formation
- Teeth without anatomic abnormalities
Who cannot join
- Pregnant females.
- If analgesics have been administrated during the past two weeks preoperatively.
- Patients having bruxism or clenching.
- Multi rooted or multi canaled teeth.
- Patients with swelling or acute peri-apical abscess.
- Previously endodontically treated teeth
- periodontally affected teeth .
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and dental medicine, Cairo University
Cairo
Nouran A Hany, BDS, +2 01223626996, nouranhany11@hotmail.com
About this study
Official title: Effect Of Using XP Endo Finisher Versus Ultrasonic Activated Irrigation On Post-operative Pain In Single Visit Endodontic Treatment of Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Recruited patients with symptomatic irreversible pulpitis are assigned to interventional (XP Endo Finisher file) and control group(ultrasonic activated irrigation) to undergo single visit endodontic treatment and record postoperative pain afterwards.
Read the detailed description
The investigator will recruit patients from the clinic of endodontics in faculty of oral and dental medicine, Cairo university.
The patients who are found eligible to the criteria, will be randomly assigned to either the control group (ultrasonic activated irrigation )or to the intervention group( XP Endo-Finisher file). Endodontic treatment will be done in single visit.
After the visit, patients will be asked to record post operative pain by NRS (Numerical Rate Scale)in a given sheet.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- XP Endo Finisher, ultrasonic activated irrigation
- Keywords
- XP Endo Finisher, ultrasonic activated irrigation, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XP Endo FinisherDevice
a flexible single use NiTi file with small diameter and no taper, changes from straight M-phase to A-phase in body temperature
ultrasonic activated irrigationDevice
Also called Irrisafe
by Satelec,Acteon, France
| Study group | Role | What they receive |
|---|---|---|
| XP Endo Finisher file | Experimental | XP Endo Finisher file is used to activate irrigation as a final step in irrigation protocol Receives: Device: XP Endo Finisher |
| ultrasonic activated irrigation | Active comparator | ultrasonic activated irrigation as a final step in irrigation protocol Receives: Device: ultrasonic activated irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pain
measured by NRS (Numerical rate scale)
Measured: up to 1 week after the visit
Secondary outcomes (1)
Number of taken analgesic tablets
counted by the patient and recorded in a given chart
Measured: within a week after the visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start15 Apr 2017
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
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 Symptomatic Irreversible PulpitisStudies 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Ahmed Hany Asal, Cairo University
- Investigators
- Nouran A Hany, BDS, Principal investigator, Department of endodontics -Faculty of Oral and Dental Medicine-Cairo universityShaimaa I Gawdat, PHD, Study director, Department of endodontics -Faculty of Oral and Dental Medicine-Cairo universityHebatallah M El-Far, Professor, Study chair, Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096587
- Sponsor's protocol ID
- CEBC-CU-2017-03-19
- Acronym
- RCT
- Status last verified
- Aug 2017
- First submitted
- 25 Mar 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alves FR, Andrade-Junior CV, Marceliano-Alves MF, Perez AR, Rocas IN, Versiani MA, Sousa-Neto MD, Provenzano JC, Siqueira JF Jr. Adjunctive Steps for Disinfection of the Mandibular Molar Root Canal System: A Correlative Bacteriologic, Micro-Computed Tomography, and Cryopulverization Approach. J Endod. 2016 Nov;42(11):1667-1672. doi: 10.1016/j.joen.2016.08.003. Epub 2016 Sep 15.
PubMed 27641947Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28.
PubMed 27248848Sadaf D, Ahmad MZ. Factors associated with postoperative pain in endodontic therapy. Int J Biomed Sci. 2014 Dec;10(4):243-7.
PubMed 25598754
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Using XP Endo Finisher Versus Ultrasonic Activated Irrigation On Post-operative Pain In Single Visit Endodontic Treatment of Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03096587
- Acronym / sponsor ID
- RCT / CEBC-CU-2017-03-19
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- XP Endo Finisher, ultrasonic activated irrigation, postoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 30 Mar 2017 (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.
Recruited patients with symptomatic irreversible pulpitis are assigned to interventional (XP Endo Finisher file) and control group(ultrasonic activated irrigation) to undergo single visit endodontic treatment and record postoperative pain afterwards.
Detailed description
The investigator will recruit patients from the clinic of endodontics in faculty of oral and dental medicine, Cairo university.
The patients who are found eligible to the criteria, will be randomly assigned to either the control group (ultrasonic activated irrigation )or to the intervention group( XP Endo-Finisher file). Endodontic treatment will be done in single visit.
After the visit, patients will be asked to record post operative pain by NRS (Numerical Rate Scale)in a given sheet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XP Endo Finisher file | Experimental | Device: XP Endo FinisherXP Endo Finisher file is used to activate irrigation as a final step in irrigation protocol |
| ultrasonic activated irrigation | Active comparator | Device: ultrasonic activated irrigationultrasonic activated irrigation as a final step in irrigation protocol |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Medically- free of any systemic disease
- Male or female
- Patients with age range 25-45
- Symptomatic irreversible pulpitis in single rooted single canal teeth without apical periodontitis.
- Teeth with mature root
Key exclusion criteria (7 listed)
- Pregnant females.
- If analgesics have been administrated during the past two weeks preoperatively.
- Patients having bruxism or clenching.
- Multi rooted or multi canaled teeth.
- Patients with swelling or acute peri-apical abscess.
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 |
|---|---|---|
| XP Endo Finishera flexible single use NiTi file with small diameter and no taper, changes from straight M-phase to A-phase in body temperature | Device | XP Endo Finisher file |
| ultrasonic activated irrigationAlso: Irrisafeby Satelec,Acteon, France | Device | ultrasonic activated irrigation |
Primary outcome
post-operative pain
Time frame: up to 1 week after the visit
measured by NRS (Numerical rate scale)
1 secondary outcome
Number of taken analgesic tablets
Time frame: within a week after the visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Results publication: PubMed 27641947Alves FR, Andrade-Junior CV, Marceliano-Alves MF, Perez AR, Rocas IN, Versiani MA, Sousa-Neto MD, Provenzano JC, Siqueira JF Jr. Adjunctive Steps for Disinfection of the Mandibular Molar Root Canal System: A Correlative Bacteriologic, Micro-Computed Tomography, and Cryopulverization Approach. J Endod. 2016 Nov;42(11):1667-1672. doi: 10.1016/j.joen.2016.08.003. Epub 2016 Sep 15.
- Results publication: PubMed 27248848Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28.
- Results publication: PubMed 25598754Sadaf D, Ahmad MZ. Factors associated with postoperative pain in endodontic therapy. Int J Biomed Sci. 2014 Dec;10(4):243-7.
- 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.
Nouran A Hany, BDS principal investigator
Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
Shaimaa I Gawdat, PHD study director
Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
Hebatallah M El-Far, Professor study chair
Department of endodontics -Faculty of Oral and Dental Medicine-Cairo 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 XP Endo Finisher and ultrasonic activated irrigation in people with Symptomatic Irreversible Pulpitis, 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 11 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 22 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nouran A Hany, BDS (+2 01223626996, nouranhany11@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative pain (time frame: up to 1 week after the visit). 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 NCT03096587, 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 22 Aug 2017.