Dental Pulp NecrosesNCT02952326
Comparing Between XP Endo Finisher and Conventional Irrigation Method On Post-Operative Flare Ups In Necrotic Teeth
A study testing XP Endo Finsher as final step of the irrigation protocol and Conventional needle irrigation only in people with Dental Pulp Necroses, run by Cairo University.
Trial summary
Comparing the postoperative flare ups and pain after adding the XP Endo Finisher to the final irrigation protocol on necrotic mandibular premolars. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Necroses
- What is being tested?
- XP Endo Finsher as final step of the irrigation protocol and Conventional needle irrigation only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-50 years old. ii. Males or Females. iii. mandibular Premolars
- Asymptomatic.
- Non-vital response of pulp tissue (negative response).
- With or without periapical radiolucency.
Who cannot join
- Patients allergic to penicillin. ii. Pregnant females. iii. Patients having significant systemic disorder. iv. If antibiotics have been administrated during the past two weeks preoperatively.
- Patients having bruxism or clenching. vi. Teeth that have :
- Vital pulp tissues.
- Association with swelling
- Acute peri-apical abscess
- Periodontally affected teeth
- No possible restorability
- Previous endodontic treatment.
About this study
Official title: Comparison Of The Effect of Adding XP Endo Finisher To The Irrigation Protocol Versus Conventional Irrigation Method On Post-Operative Flare Ups In Necrotic Teeth
Comparing the postoperative flare ups and pain after adding the XP Endo Finisher to the final irrigation protocol on necrotic mandibular premolars.
Read the detailed description
patients are randomized into 2 groups after meeting the eligibility criteria,
- Each patient will be given pain scale chart in order to record his /her pain level before any intervention.
- The tooth is anesthetized, accessed and mechanical instrumentation to be made 3 A) For the experimental group: The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument. XP Endo finisher is used after the last instrument in preparation
- For the control group :
The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument.
- Obturation is done and postoperative instructions are given to the patient
- Conditions
- Dental Pulp Necroses
- Being tested
- XP Endo Finsher as final step of the irrigation protocol, Conventional needle irrigation only
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XP Endo Finsher as final step of the irrigation protocolProcedure or surgery
The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument. XP Endo finisher is used after the last instrument in preparation
Conventional needle irrigation onlyProcedure or surgery
The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument.
| Study group | Role | What they receive |
|---|---|---|
| XP Endo Finisher | Experimental | Not described Receives: Procedure: XP Endo Finsher as final step of the irrigation protocol |
| Conventional needle irrigation | Active comparator | Not described Receives: Procedure: Conventional needle irrigation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain recorded by the patient using a four step pain scale (0-3)
Measured: up to 5 days after the treatment
Secondary outcomes (3)
Post-operative swelling
Measured: up to 5 days after the treatment
Need\ number of Analgesic tablets
Measured: up to 5 days after the treatment
Need for systemic antibiotics
Measured: up to 5 days after the 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 startDec 2016
- Primary completionNov 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 (2)Papers the sponsor has linked to this study.
- Other trials for Dental Pulp NecrosesStudies 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Ihab Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952326
- Sponsor's protocol ID
- XP and Protaper next
- Status last verified
- Nov 2016
- First submitted
- 31 Oct 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Elnaghy AM, Mandorah A, Elsaka SE. Effectiveness of XP-endo Finisher, EndoActivator, and File agitation on debris and smear layer removal in curved root canals: a comparative study. Odontology. 2017 Apr;105(2):178-183. doi: 10.1007/s10266-016-0251-8. Epub 2016 May 20.
PubMed 27206916Siqueira JF Jr. Microbial causes of endodontic flare-ups. Int Endod J. 2003 Jul;36(7):453-63. doi: 10.1046/j.1365-2591.2003.00671.x.
PubMed 12823700
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Effect of Adding XP Endo Finisher To The Irrigation Protocol Versus Conventional Irrigation Method On Post-Operative Flare Ups In Necrotic Teeth
- ClinicalTrials.gov ID
- NCT02952326
- Acronym / sponsor ID
- XP and Protaper next
- Conditions
- Dental Pulp Necroses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Nov 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.
Comparing the postoperative flare ups and pain after adding the XP Endo Finisher to the final irrigation protocol on necrotic mandibular premolars.
Detailed description
patients are randomized into 2 groups after meeting the eligibility criteria,
- Each patient will be given pain scale chart in order to record his /her pain level before any intervention.
- The tooth is anesthetized, accessed and mechanical instrumentation to be made 3 A) For the experimental group: The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument. XP Endo finisher is used after the last instrument in preparation
- For the control group :
The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument.
- Obturation is done and postoperative instructions are given to the patient
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XP Endo Finisher | Experimental | Procedure: XP Endo Finsher as final step of the irrigation protocol |
| Conventional needle irrigation | Active comparator | Procedure: Conventional needle irrigation only |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18-50 years old. ii. Males or Females. iii. mandibular Premolars
- Asymptomatic.
- Non-vital response of pulp tissue (negative response).
- With or without periapical radiolucency.
Key exclusion criteria (8 listed)
- Patients allergic to penicillin. ii. Pregnant females. iii. Patients having significant systemic disorder. iv. If antibiotics have been administrated during the past two weeks preoperatively.
- Patients having bruxism or clenching. vi. Teeth that have :
- Vital pulp tissues.
- Association with swelling
- 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 Finsher as final step of the irrigation protocolThe canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument. XP Endo finisher is used after the last instrument in preparation | Procedure or surgery | XP Endo Finisher |
| Conventional needle irrigation onlyThe canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument. | Procedure or surgery | Conventional needle irrigation |
Primary outcome
Post-operative pain recorded by the patient using a four step pain scale (0-3)
Time frame: up to 5 days after the treatment
3 secondary outcomes
Post-operative swelling
Time frame: up to 5 days after the treatment
Need\ number of Analgesic tablets
Time frame: up to 5 days after the treatment
Need for systemic antibiotics
Time frame: up to 5 days after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Background: PubMed 27206916Elnaghy AM, Mandorah A, Elsaka SE. Effectiveness of XP-endo Finisher, EndoActivator, and File agitation on debris and smear layer removal in curved root canals: a comparative study. Odontology. 2017 Apr;105(2):178-183. doi: 10.1007/s10266-016-0251-8. Epub 2016 May 20.
- Background: PubMed 12823700Siqueira JF Jr. Microbial causes of endodontic flare-ups. Int Endod J. 2003 Jul;36(7):453-63. doi: 10.1046/j.1365-2591.2003.00671.x.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing XP Endo Finsher as final step of the irrigation protocol and Conventional needle irrigation only in people with Dental Pulp Necroses, 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 8 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 15 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?
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?
Post-operative pain recorded by the patient using a four step pain scale (0-3) (time frame: up to 5 days after the 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 NCT02952326, 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 15 Nov 2016.