Dental Pulp NecrosisNCT02946099
Comparison Between Reciproc and Protaper Next
A study testing Reciproc files in reciprocating motion and ProTaper Next files in continuous rotary motion in people with Dental Pulp Necrosis, run by Cairo University at 1 site in Egypt.
Trial summary
Comparing the postoperative pain resulting after mechanical instrumentation using Reciproc reciprocating files versus that resulting after using ProTaper Next rotary files in asymptomatic necrotic molars. Read more about this study
- Who is it for?
- Ages 15 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Necrosis
- What is being tested?
- Reciproc files in reciprocating motion and ProTaper Next files in continuous rotary motion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2016to Nov 2017
- 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 15 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Mandibular molar teeth with no pain, no response of pulp tissue to pulp testing and teeth with apical periodontitis
Who cannot join
- Patients on medication for chronic pain
- Patients with pre-operative pain.
- Patients having significant systemic disorders.
- Patients with two or more adjacent teeth requiring root canal therapy
- teeth that have vital pulp tissues, greater than grade I mobility, pocket depth greater than 5 mm, no possible restorability or previous endodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Pain After Root Canal Instrumentation Using Reciproc and ProTaper Next in Asymptomatic Necrotic Molars: A Randomized Clinical Trial
Comparing the postoperative pain resulting after mechanical instrumentation using Reciproc reciprocating files versus that resulting after using ProTaper Next rotary files in asymptomatic necrotic molars.
Read the detailed description
Asymptomatic Necrotic molars are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using Reciproc Files or ProTaper Next files. Postoperative pain is then assessed using the Numerical Rating scale 6, 12, 24 and 48 hours post-instrumentation. The tooth is then temporized and after 1 week obturation is then and post obturation pain is assessed using the Numerical Rating scale after 12 and 24 hours following obturation. The time required to complete instrumentation is also measured and compared using the two files.
- Conditions
- Dental Pulp Necrosis
- Being tested
- Reciproc files in reciprocating motion, ProTaper Next files in continuous rotary motion
- 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.
Reciproc files in reciprocating motionProcedure or surgery
An endodontic file that works through a reciprocating motion
ProTaper Next files in continuous rotary motionProcedure or surgery
An endodontic file that works through a continuous rotary motion
| Study group | Role | What they receive |
|---|---|---|
| Reciproc file | Experimental | Reciproc files in reciprocating motion Receives: Procedure: Reciproc files in reciprocating motion |
| ProTaper Next file | Active comparator | ProTaper Next files in continuous rotary motion Receives: Procedure: ProTaper Next files in continuous rotary motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain assessed with the Numerical Rating Pain Scale
1 to 10 Numerical Rating Pain Scale up to 48 hours post-instrumentation
Measured: Up to 48 hours post-instrumentation
Post-obturation pain assessed with the Numerical Rating Pain Scale
1 to 10 Numerical Rating Pain Scale up to 24 hours following obturation
Measured: up to 24 hours following obturation
Secondary outcomes (1)
Time required to complete instrumentation
time required to complete instrumentation
Measured: From the completion of the access cavity preparation till the end of cleaning and shaping procedure up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startNov 2016
- Primary completion14 Oct 2017
- Study completionNov 2017
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 NecrosisStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Ayman Abo El Enin Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946099
- Sponsor's protocol ID
- reciproc_protapernext
- Status last verified
- Nov 2017
- First submitted
- 24 Oct 2016
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nekoofar MH, Sheykhrezae MS, Meraji N, Jamee A, Shirvani A, Jamee J, Dummer PM. Comparison of the effect of root canal preparation by using WaveOne and ProTaper on postoperative pain: a randomized clinical trial. J Endod. 2015 May;41(5):575-8. doi: 10.1016/j.joen.2014.12.026. Epub 2015 Feb 24.
PubMed 25720984Burklein S, Schafer E. Apically extruded debris with reciprocating single-file and full-sequence rotary instrumentation systems. J Endod. 2012 Jun;38(6):850-2. doi: 10.1016/j.joen.2012.02.017. Epub 2012 Apr 6.
PubMed 22595125
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain After Root Canal Instrumentation Using Reciproc and ProTaper Next in Asymptomatic Necrotic Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02946099
- Acronym / sponsor ID
- reciproc_protapernext
- Conditions
- Dental Pulp Necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 14 Oct 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 26 Oct 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 pain resulting after mechanical instrumentation using Reciproc reciprocating files versus that resulting after using ProTaper Next rotary files in asymptomatic necrotic molars.
Detailed description
Asymptomatic Necrotic molars are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using Reciproc Files or ProTaper Next files. Postoperative pain is then assessed using the Numerical Rating scale 6, 12, 24 and 48 hours post-instrumentation. The tooth is then temporized and after 1 week obturation is then and post obturation pain is assessed using the Numerical Rating scale after 12 and 24 hours following obturation. The time required to complete instrumentation is also measured and compared using the two files.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reciproc file | Experimental | Procedure: Reciproc files in reciprocating motionReciproc files in reciprocating motion |
| ProTaper Next file | Active comparator | Procedure: ProTaper Next files in continuous rotary motionProTaper Next files in continuous rotary motion |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Mandibular molar teeth with no pain, no response of pulp tissue to pulp testing and teeth with apical periodontitis
Key exclusion criteria (5 listed)
- Patients on medication for chronic pain
- Patients with pre-operative pain.
- Patients having significant systemic disorders.
- Patients with two or more adjacent teeth requiring root canal therapy
- teeth that have vital pulp tissues, greater than grade I mobility, pocket depth greater than 5 mm, no possible restorability or previous endodontic 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 |
|---|---|---|
| Reciproc files in reciprocating motionAn endodontic file that works through a reciprocating motion | Procedure or surgery | Reciproc file |
| ProTaper Next files in continuous rotary motionAn endodontic file that works through a continuous rotary motion | Procedure or surgery | ProTaper Next file |
Primary outcome
Post operative pain assessed with the Numerical Rating Pain Scale
Time frame: Up to 48 hours post-instrumentation
1 to 10 Numerical Rating Pain Scale up to 48 hours post-instrumentation
Post-obturation pain assessed with the Numerical Rating Pain Scale
Time frame: up to 24 hours following obturation
1 to 10 Numerical Rating Pain Scale up to 24 hours following obturation
1 secondary outcome
Time required to complete instrumentation
Time frame: From the completion of the access cavity preparation till the end of cleaning and shaping procedure up to 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Background: PubMed 25720984Nekoofar MH, Sheykhrezae MS, Meraji N, Jamee A, Shirvani A, Jamee J, Dummer PM. Comparison of the effect of root canal preparation by using WaveOne and ProTaper on postoperative pain: a randomized clinical trial. J Endod. 2015 May;41(5):575-8. doi: 10.1016/j.joen.2014.12.026. Epub 2015 Feb 24.
- Background: PubMed 22595125Burklein S, Schafer E. Apically extruded debris with reciprocating single-file and full-sequence rotary instrumentation systems. J Endod. 2012 Jun;38(6):850-2. doi: 10.1016/j.joen.2012.02.017. Epub 2012 Apr 6.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reciproc files in reciprocating motion and ProTaper Next files in continuous rotary motion in people with Dental Pulp Necrosis, 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 7 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 assessed with the Numerical Rating Pain Scale (time frame: Up to 48 hours post-instrumentation). The study lists 2 primary outcomes in all. 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 NCT02946099, 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 Nov 2017.