Apical PeriodontitisNCT02913937
Effect of Passive Ultrasonic Irrigation Versus Needle Irrigation on Postoperative Pain and Periapical Healing
A study testing Passive ultrasonic irrigation and Endodontic needle in people with Apical Periodontitis, run by Cairo University.
Trial summary
The aim of this study is to compare the effect of passive ultrasonic irrigation versus needle irrigation on post-operative pain and healing in patients with permanent posterior teeth with apical periodontitis treated in a single visit. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Passive ultrasonic irrigation and Endodontic needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Jan 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-55 years old.
- Males and females.
- Positive patient's acceptance to participate in the study.
- Mature, permanent, mandibular, posterior teeth with apical periodontitis.
Who cannot join
- Medically compromised patients so that no other pain source or drug interaction could interfere with pain resulting from the endodontic therapy.
- Patients who had received analgesic treatment recently (past 8 hours) as it can affect the results
- Pregnant females.
- Teeth with previous root canal treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Postoperative Pain and Healing After Passive Ultrasonic Irrigation and Needle Irrigation in Patients With Apical Periodontitis: A Randomized Clinical Trial
The aim of this study is to compare the effect of passive ultrasonic irrigation versus needle irrigation on post-operative pain and healing in patients with permanent posterior teeth with apical periodontitis treated in a single visit.
Read the detailed description
Full medical and dental history using a dental chart for all patients treated in this study.
Clinical and radiographic examination will be done for all patients to verify the diagnosis of apical periodontitis with periapical radiolucency at least 2mm in diameter.
The treatment protocol and its associated risks and benefits will be explained to the eligible patients before obtaining informed consent. Endodontic procedures will be done in a single visit as follows: access cavity preparation using sterile round bur and Endo-Z bur, isolation using a rubber dam, canal preparation using a nickel-titanium rotary system then obturation. During mechanical preparation, irrigation will be done using passive ultrasonic irrigation (Experimental group) where ultrasonic activation will be done for irrigant-filled canals using the U- file tip (Varios NSK) in an ultrasonic device (P5 Newtron; Satelec Acteon) 1mm from the working length after each file change for 10 sec, or needle irrigation (Control group) where only the endodontic irrigation needle will be used; the irrigation protocol for each patient will be determined following a random-number sequence.
- Conditions
- Apical Periodontitis
- Being tested
- Passive ultrasonic irrigation, Endodontic needle
- Keywords
- ultrasonic irrigation, pain, healing, apical periodontitis
- Medical subject headings
- Periapical Periodontitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive ultrasonic irrigationDevice
Endodontic irrigation followed by passive ultrasonic agitation.
Endodontic needleDevice
Endodontic irrigation
| Study group | Role | What they receive |
|---|---|---|
| Needle irrigation | Active comparator | Endodontic irrigation will be done using an endodontic needle. Receives: Device: Endodontic needle |
| Passive ultrasonic irrigation | Experimental | Endodontic passive ultrasonic irrigation will be done using an endodontic needle followed by passive ultrasonic agitation. Receives: Device: Passive ultrasonic irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
postoperative pain will be assessed using numerical rate scale (NRS).
Measured: 7 days
Secondary outcomes (1)
Periapical healing
Periapical healing will be assessed using periapical index (PAI).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startFeb 2017 (estimated)
- Primary completionFeb 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Apical PeriodontitisStudies 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Tawfik aly, Cairo University
- Investigators
- Randa El-Bogdady, Study director, Cairo UniversitySuzan AW Amin, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913937
- Sponsor's protocol ID
- CEBD-CU-2016-09-201
- Status last verified
- Oct 2016
- First submitted
- 22 Sep 2016
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.
PubMed 20647083Middha 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 27248848
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain and Healing After Passive Ultrasonic Irrigation and Needle Irrigation in Patients With Apical Periodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02913937
- Acronym / sponsor ID
- CEBD-CU-2016-09-201
- Conditions
- Apical Periodontitis
- Keywords
- ultrasonic irrigation, pain, healing, apical periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2017 (estimated)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 26 Sep 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 of this study is to compare the effect of passive ultrasonic irrigation versus needle irrigation on post-operative pain and healing in patients with permanent posterior teeth with apical periodontitis treated in a single visit.
Detailed description
Full medical and dental history using a dental chart for all patients treated in this study.
Clinical and radiographic examination will be done for all patients to verify the diagnosis of apical periodontitis with periapical radiolucency at least 2mm in diameter.
The treatment protocol and its associated risks and benefits will be explained to the eligible patients before obtaining informed consent. Endodontic procedures will be done in a single visit as follows: access cavity preparation using sterile round bur and Endo-Z bur, isolation using a rubber dam, canal preparation using a nickel-titanium rotary system then obturation. During mechanical preparation, irrigation will be done using passive ultrasonic irrigation (Experimental group) where ultrasonic activation will be done for irrigant-filled canals using the U- file tip (Varios NSK) in an ultrasonic device (P5 Newtron; Satelec Acteon) 1mm from the working length after each file change for 10 sec, or needle irrigation (Control group) where only the endodontic irrigation needle will be used; the irrigation protocol for each patient will be determined following a random-number sequence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needle irrigation | Active comparator | Device: Endodontic needleEndodontic irrigation will be done using an endodontic needle. |
| Passive ultrasonic irrigation | Experimental | Device: Passive ultrasonic irrigationEndodontic passive ultrasonic irrigation will be done using an endodontic needle followed by passive ultrasonic agitation. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18-55 years old.
- Males and females.
- Positive patient's acceptance to participate in the study.
- Mature, permanent, mandibular, posterior teeth with apical periodontitis.
Key exclusion criteria (4 listed)
- Medically compromised patients so that no other pain source or drug interaction could interfere with pain resulting from the endodontic therapy.
- Patients who had received analgesic treatment recently (past 8 hours) as it can affect the results
- Pregnant females.
- Teeth with previous root canal treatment.
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 |
|---|---|---|
| Passive ultrasonic irrigationEndodontic irrigation followed by passive ultrasonic agitation. | Device | Passive ultrasonic irrigation |
| Endodontic needleEndodontic irrigation | Device | Needle irrigation |
Primary outcome
Postoperative pain
Time frame: 7 days
postoperative pain will be assessed using numerical rate scale (NRS).
1 secondary outcome
Periapical healing
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Background: PubMed 20647083Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.
- Background: 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.
- 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.
Randa El-Bogdady study director
Cairo University
Suzan AW Amin study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Passive ultrasonic irrigation and Endodontic needle in people with Apical Periodontitis, 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 4 inclusion and 4 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 9 Feb 2017. 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 Noha aly, Postgraduate (01015011128, nohatawfik26@hotmail.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: 7 days). 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 NCT02913937, which also lists 2 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 9 Feb 2017.