Postoperative PainNCT03338322
Postoperative Pain After Using Reciprocating Motion With Reciproc Files Versus Adaptive Motion With Twisted File Adaptive
A study testing Twisted file adaptive and Reciproc in people with Postoperative Pain, run by Cairo University.
Trial summary
assess the effect of using reciprocating motion with reciproc files versus adaptive motion using twisted file adaptive on postoperative pain after instrumentation of necrotic mandibular molars. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Twisted file adaptive and Reciproc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Dec 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
- Patients who are medically free from any systemic disease that may contraindicate our interventions.
- Patient's age between 18-60 years old.
- Mandibular molars having necrotic pulps with symptomatic or asymptomatic apical periodontitis because this group of patients may have more postoperative pain than vital teeth22.
- Positive patient's acceptance for participation in the study.
Who cannot join
- Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment to give true response of pain after instrumentation.
- Teeth with vital pulps or Symptomatic irreversible pulpitis.
- Pregnant patients or lactating because of radiographic hazards and use of analgesics27.
- Any known sensitivity or adverse reactions to ibuprofen.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Postoperative Pain After Using Reciprocating Motion With Reciproc Files Versus Adaptive Motion With Twisted File Adaptive In Instrumentation Of Necrotic Mandibular Molars: A Randomized Clinical Trial
assess the effect of using reciprocating motion with reciproc files versus adaptive motion using twisted file adaptive on postoperative pain after instrumentation of necrotic mandibular molars.
Read the detailed description
In root canal treatment of mandibular molar teeth in patients having necrotic pulp with symptomatic or asymptomatic apical periodontitis, Is there difference in postoperative pain after instrumentation between two different kinematics; adaptive motion using Twisted File Adaptive and reciprocation motion using Reciproc
- Conditions
- Postoperative Pain
- Being tested
- Twisted file adaptive, Reciproc
- Keywords
- postoperative pain, reciproc, twisted file adaptive
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twisted file adaptiveDevice
Endodontic files that are used in preparation of root canals with adaptive motion
ReciprocDevice
Endodontic files that are used in root canal preparation with reciprocation motion
| Study group | Role | What they receive |
|---|---|---|
| Twisted file adaptive | Experimental | Files that are used in root canal preparation in adaptive motion Receives: Device: Twisted file adaptive |
| Reciproc | Active comparator | Reciproc files are used in root canal preparation with reciprocation motion Receives: Device: Reciproc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post instrumentation pain
post instrumentation pain will be recorded by the patient using numerical rating scale (0-10) will be used to record pain intensity
Measured: up to 7 days
Secondary outcomes (2)
analgesic intake
number of analgesic intake will be recorded by the patient
Measured: up to 7 days
Colony forming units
calculation of colony forming units before and after instrumentation
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study startJan 2018 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Yaser Abu Bakr, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338322
- Sponsor's protocol ID
- twisted file adaptive 1987
- Status last verified
- Nov 2017
- First submitted
- 3 Nov 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: participant data will be recorded and shared
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Using Reciprocating Motion With Reciproc Files Versus Adaptive Motion With Twisted File Adaptive In Instrumentation Of Necrotic Mandibular Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03338322
- Acronym / sponsor ID
- twisted file adaptive 1987
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain, reciproc, twisted file adaptive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Nov 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.
assess the effect of using reciprocating motion with reciproc files versus adaptive motion using twisted file adaptive on postoperative pain after instrumentation of necrotic mandibular molars.
Detailed description
In root canal treatment of mandibular molar teeth in patients having necrotic pulp with symptomatic or asymptomatic apical periodontitis, Is there difference in postoperative pain after instrumentation between two different kinematics; adaptive motion using Twisted File Adaptive and reciprocation motion using Reciproc
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Twisted file adaptive | Experimental | Device: Twisted file adaptiveFiles that are used in root canal preparation in adaptive motion |
| Reciproc | Active comparator | Device: ReciprocReciproc files are used in root canal preparation with reciprocation motion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who are medically free from any systemic disease that may contraindicate our interventions.
- Patient's age between 18-60 years old.
- Mandibular molars having necrotic pulps with symptomatic or asymptomatic apical periodontitis because this group of patients may have more postoperative pain than vital teeth22.
- Positive patient's acceptance for participation in the study.
Key exclusion criteria (4 listed)
- Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment to give true response of pain after instrumentation.
- Teeth with vital pulps or Symptomatic irreversible pulpitis.
- Pregnant patients or lactating because of radiographic hazards and use of analgesics27.
- Any known sensitivity or adverse reactions to ibuprofen.
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 |
|---|---|---|
| Twisted file adaptiveEndodontic files that are used in preparation of root canals with adaptive motion | Device | Twisted file adaptive |
| ReciprocEndodontic files that are used in root canal preparation with reciprocation motion | Device | Reciproc |
Primary outcome
Post instrumentation pain
Time frame: up to 7 days
post instrumentation pain will be recorded by the patient using numerical rating scale (0-10) will be used to record pain intensity
2 secondary outcomes
analgesic intake
Time frame: up to 7 days
Colony forming units
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Individual participant dataSharing planned: Undecided. participant data will be recorded and shared
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Twisted file adaptive and Reciproc in people with Postoperative Pain, 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 Nov 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 abu bakr (+201225877183, ahmed.abubakr@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post instrumentation pain (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2017.