Tooth, NonvitalNCT02984488
Pain Following One-visit Versus Two-visit Root Canal of Necrotic Teeth Using Protaper Next
A study testing single visits and two visits in people with Tooth, Nonvital, run by Cairo University.
Trial summary
To evaluate the incidence and severity of postoperative pain after root canal therapy of necrotic teeth in one appointment versus two appointments using Protaper next instrument. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth, Nonvital
- What is being tested?
- single visits and two visits
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Feb 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically free patients.
- Patient's age above 18 years old.
- Teeth diagnosed clinically with necrosis.
- Positive patient's acceptance for participation in the study.
- Sex includes both male and female.
- Patients who can understand visual analogue scale.
- Patients able to sign informed consent.
Who cannot join
- Pregnancy or lactation.
- Medically compromised patients.
- Patient with multiple teeth that required treatment in the same quadrant to eliminate the possibility of pain referral.
Trial locations and contacts
No sites are listed yet.
Abeer sabi, lecturer contact
About this study
Official title: Post-Obturation Pain Following One-visit Versus Two-visit Root Canal Treatment of Necrotic Anterior and Premolar Teeth Using Protaper Next
To evaluate the incidence and severity of postoperative pain after root canal therapy of necrotic teeth in one appointment versus two appointments using Protaper next instrument.
Read the detailed description
The key to endodontic success was described as the debridement and neutralization of any tissue, bacteria, or inflammatory products within the root canal system.
Endodontic treatment used to take multiple visits to complete, with one of the main reasons for this being that it required a considerable amount of time to complete the treatment.
The single-visit treatment was bought back in the 1950s by Ferranti, who advocated the use of diathermy for pulpal disinfection and hydrogen peroxide for irrigation.
The use of contemporary endodontic techniques and equipment, such as use of rubber dam, magnifying devices, electronic apex locators, engine-driven rotary nickel titanium files, and so forth, not only increases the success rate of endodontic treatment but also, shortens the time needed for the treatment. Endodontic treatment may therefore be completed in a single visit.
It is generally agreed upon that the prepared canals can never be sterile before obturation, no matter how potent the antibacterial irrigants or intracanal medications are. There are currently two measures to reduce bacterial persistence and reinfection in the canals. We can either dress the canals with antibacterial agents in multiple visits or immediately obturate the canals, to reduce the space for bacterial colonization, in a single-visit approach. Calcium hydroxide is the most commonly used intracanal medicament, however its efficacy towards Enterococcus faecalis is questionable.
- Conditions
- Tooth, Nonvital
- Being tested
- single visits, two visits
- Keywords
- necrotic teeth, single visit, multiple visits, protaper next
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single visitsProcedure or surgery
Endodontic treatment is done and completed in a single visit using protaper next rotary system.
two visitsProcedure or surgery
Endodontic treatment is done and completed in two visits using protaper next rotary system.
| Study group | Role | What they receive |
|---|---|---|
| single visit endodontic treatment. | Experimental | •single visit endodontic Treatment of necrotic teeth using Protaper next. Receives: Procedure: single visits |
| Two visits endodontic treatment | Active comparator | •Two visits endodontic Treatment of necrotic teeth using Protaper next. Receives: Procedure: two visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of post operative pain.
Measured: After 6-12-24-48 hours from the obturation step of the endodontic treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionFeb 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 Tooth, NonvitalStudies 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebatallah Mostafa Mahmoud Ahmed Nada, Cairo University
- Investigators
- Saeed M Abd El aziz, professor, Study chair, Department of endodontics - Faculty of Oral and Dental medicine - CUhebatallah M nada, student, Principal investigator, Department of endodontics - Faculty of Oral and Dental medicine - CU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984488
- Sponsor's protocol ID
- single_two visits
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rao KN, Kandaswamy R, Umashetty G, Rathore VP, Hotkar C, Patil BS. Post-Obturation pain following one-visit and two-visit root canal treatment in necrotic anterior teeth. J Int Oral Health. 2014 Apr;6(2):28-32. Epub 2014 Apr 26.
PubMed 24876699DiRenzo A, Gresla T, Johnson BR, Rogers M, Tucker D, BeGole EA. Postoperative pain after 1- and 2-visit root canal therapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 May;93(5):605-10. doi: 10.1067/moe.2002.121900.
PubMed 12075212
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Obturation Pain Following One-visit Versus Two-visit Root Canal Treatment of Necrotic Anterior and Premolar Teeth Using Protaper Next
- ClinicalTrials.gov ID
- NCT02984488
- Acronym / sponsor ID
- single_two visits
- Conditions
- Tooth, Nonvital
- Keywords
- necrotic teeth, single visit, multiple visits, protaper next
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 7 Dec 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.
To evaluate the incidence and severity of postoperative pain after root canal therapy of necrotic teeth in one appointment versus two appointments using Protaper next instrument.
Detailed description
The key to endodontic success was described as the debridement and neutralization of any tissue, bacteria, or inflammatory products within the root canal system.
Endodontic treatment used to take multiple visits to complete, with one of the main reasons for this being that it required a considerable amount of time to complete the treatment.
The single-visit treatment was bought back in the 1950s by Ferranti, who advocated the use of diathermy for pulpal disinfection and hydrogen peroxide for irrigation.
The use of contemporary endodontic techniques and equipment, such as use of rubber dam, magnifying devices, electronic apex locators, engine-driven rotary nickel titanium files, and so forth, not only increases the success rate of endodontic treatment but also, shortens the time needed for the treatment. Endodontic treatment may therefore be completed in a single visit.
It is generally agreed upon that the prepared canals can never be sterile before obturation, no matter how potent the antibacterial irrigants or intracanal medications are. There are currently two measures to reduce bacterial persistence and reinfection in the canals. We can either dress the canals with antibacterial agents in multiple visits or immediately obturate the canals, to reduce the space for bacterial colonization, in a single-visit approach. Calcium hydroxide is the most commonly used intracanal medicament, however its efficacy towards Enterococcus faecalis is questionable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single visit endodontic treatment. | Experimental | Procedure: single visits•single visit endodontic Treatment of necrotic teeth using Protaper next. |
| Two visits endodontic treatment | Active comparator | Procedure: two visits•Two visits endodontic Treatment of necrotic teeth using Protaper next. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Medically free patients.
- Patient's age above 18 years old.
- Teeth diagnosed clinically with necrosis.
- Positive patient's acceptance for participation in the study.
- Sex includes both male and female.
Key exclusion criteria (3 listed)
- Pregnancy or lactation.
- Medically compromised patients.
- Patient with multiple teeth that required treatment in the same quadrant to eliminate the possibility of pain referral.
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 |
|---|---|---|
| single visitsEndodontic treatment is done and completed in a single visit using protaper next rotary system. | Procedure or surgery | single visit endodontic treatment. |
| two visitsEndodontic treatment is done and completed in two visits using protaper next rotary system. | Procedure or surgery | Two visits endodontic treatment |
Primary outcome
Change of post operative pain.
Time frame: After 6-12-24-48 hours from the obturation step of the endodontic treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Background: PubMed 24876699Rao KN, Kandaswamy R, Umashetty G, Rathore VP, Hotkar C, Patil BS. Post-Obturation pain following one-visit and two-visit root canal treatment in necrotic anterior teeth. J Int Oral Health. 2014 Apr;6(2):28-32. Epub 2014 Apr 26.
- Background: PubMed 12075212DiRenzo A, Gresla T, Johnson BR, Rogers M, Tucker D, BeGole EA. Postoperative pain after 1- and 2-visit root canal therapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 May;93(5):605-10. doi: 10.1067/moe.2002.121900.
- 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.
Abeer sabi, lecturer contact
Saeed M Abd El aziz, professor study chair
Department of endodontics - Faculty of Oral and Dental medicine - CU
hebatallah M nada, student principal investigator
Department of endodontics - Faculty of Oral and Dental medicine - CU
Questions about this trial
What is this clinical trial studying?
A study testing single visits and two visits in people with Tooth, Nonvital, 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 7 inclusion and 3 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 7 Dec 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 hebatallah M nada, student (o1112393619, dr_heba_nada@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of post operative pain. (time frame: After 6-12-24-48 hours from the obturation step of the endodontic 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 NCT02984488, 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 7 Dec 2016.