Postoperative PainNCT03285334
3D Instrumentation Versus Rotary Instrumentation
A study testing XP-endo Shaper and iRace files in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
enrollment of the patient after diagnosis, radiographic evaluation, and signing the informed consent. allocation of the patient to either intervention or control group. After anaesthesia and access cavity, the first root canal sample will be taken. Endodontic treatment will be completed in one visit. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- XP-endo Shaper and iRace files
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2017to Nov 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Adult patients.
- Age between 20-40 years old.
- Males \& Females.
- Asymptomatic necrotic mandibular premolars with or without periapical radiolucency.
- Normal occlusal contact with the opposing teeth.
- Patients accepting to participate in the study.
Who cannot join
- Medically compromised patients
- Pregnant women
- If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively
- Patients reporting bruxism or clenching
- Teeth that shows:
- Association with acute periapical abscess and swelling
- Greater than grade I mobility or pocket depth greater than 5mm
- No restorability
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Oral and Dental Medicine - Cairo University
Cairo, Manial, 11553
Radwa Emara, 01272141312, radwa.emara@dentistry.cu.edu.eg
About this study
Official title: The Effect of 3D Instrumentation Versus Rotary Instrumentation on Postoperative Pain and Bacterial Reduction in Necrotic Oval Canals: A Randomized Clinical Trial
enrollment of the patient after diagnosis, radiographic evaluation, and signing the informed consent.
allocation of the patient to either intervention or control group. After anaesthesia and access cavity, the first root canal sample will be taken. Endodontic treatment will be completed in one visit. The second root canal sample will be taken. Patients will be asked to evaluate their postoperative pain level using VAS scale at 6, 12, 24 hours, and daily up to 5 days. Patients will record the number of analgesics if any taken.
Read the detailed description
After diagnosing the case as asymptomatic pulp necrosis and confirming that the patient conforms to all eligibility criteria, (R.S) will enroll the patient in the study.
the operator will complete treatment of all cases in single visit as following:
- Anesthetizing the tooth using inferior alveolar nerve block technique
- Removal of Caries and/or coronal restorations completely with sterile bur and rubber dam will be applied.
- Preparation of access cavity using another sterile round carbide bur size 3 and Endo-z bur .
- (R.S) will take the preinstrumentation root canal sample (S1)
- Confirming the patency of the root canals using stainless steel hand K-files size #10 and #15 . Working length will be determined .
- In the intervention group, (R.S) will perform mechanical preparation in a 3D manner using Xp-endo Shaper single file in an endodontic motor at a speed of 800 rpm and a torque of 1 Ncm.
- In the control group, mechanical preparation will be done using rotary iRace files (#25/0.04, #30/0.04, and #40/0.04) at a speed of 600 rpm and a torque of 1.5 Ncm. The canal will be irrigated and recapitulated after the use of each instrument.
- EDTA gel will be used as a lubricant. The canals will be thoroughly irrigated using 3ml of 2.5% sodium hypochlorite.
- The canal will then be dried by using sterile paper points and then flushed with 5 ml of 5% sodium thiosulfate to inactivate the NaOCl. The postinstrumentation sample (S2) will be taken from the canals.
- Master cones will be fitted to the working length and a radiograph will be taken to ensure proper length.
- (R.S) will complete obturation using AdSeal resin-based root canal sealer .
- Conditions
- Postoperative Pain
- Being tested
- XP-endo Shaper, iRace files
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XP-endo ShaperDevice
Also called anatomical (3D) shaping file
mechanical preparation in a 3D manner using Xp-endo Shaper
iRace filesDevice
Also called rotary files
rotary mechanical preparation
| Study group | Role | What they receive |
|---|---|---|
| XP-endo Shaper | Experimental | The XP-endo Shaper is an innovative single instrument manufactured from Max wire. Its special ability to shift crystalline structure at body temperature in order to adapt to the root canal wall, has provided a unique instrument with the promise of anatomical shaping. Receives: Device: XP-endo Shaper |
| iRace | Active comparator | rotary files Receives: Device: iRace files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Degree of postoperative pain will be measured by the patients using modified VAS
Measured: up to 5 days
Secondary outcomes (2)
intracanal bacterial reduction
The intra-canal bacterial count will be determined using culture technique in the microbiological department, Cairo University. Samples in RTF vials will be dispersed with vortex for 30 seconds by the laboratory technician. The RTF solution will be serially diluted one-tenth dilution and spiral plated onto the agar medium. The plates will be incubated at 37ₒc aerobically and anaerobically.
The resultant anaerobic growth will be quantified by evaluating the colony forming units (CFU) on the agar medium under the microscope and the number of CFU per milliliter of each dilution will be calculated for each sample.
Measured: 6 hours
Incidence of analgesic intake
In case of presence of moderate or severe postoperative pain, (R.S) will instruct the patients to take only one capsule of placebo given to him/her at the end of the visit (Powdered milk packed in opaque capsules)
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study startNov 2017 (estimated)
- Primary completionFeb 2018 (estimated)
- Study completionNov 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Sameeh Emara, Cairo University
- Investigators
- Radwa Emara, Principal investigator, faculty of oral and dental medicine - cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285334
- Sponsor's protocol ID
- CEBD-CU-2017-09-19
- Status last verified
- Sep 2017
- First submitted
- 13 Sep 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 3D Instrumentation Versus Rotary Instrumentation on Postoperative Pain and Bacterial Reduction in Necrotic Oval Canals: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03285334
- Acronym / sponsor ID
- CEBD-CU-2017-09-19
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 18 Sep 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.
enrollment of the patient after diagnosis, radiographic evaluation, and signing the informed consent.
allocation of the patient to either intervention or control group. After anaesthesia and access cavity, the first root canal sample will be taken. Endodontic treatment will be completed in one visit. The second root canal sample will be taken. Patients will be asked to evaluate their postoperative pain level using VAS scale at 6, 12, 24 hours, and daily up to 5 days. Patients will record the number of analgesics if any taken.
Detailed description
After diagnosing the case as asymptomatic pulp necrosis and confirming that the patient conforms to all eligibility criteria, (R.S) will enroll the patient in the study.
the operator will complete treatment of all cases in single visit as following:
- Anesthetizing the tooth using inferior alveolar nerve block technique
- Removal of Caries and/or coronal restorations completely with sterile bur and rubber dam will be applied.
- Preparation of access cavity using another sterile round carbide bur size 3 and Endo-z bur .
- (R.S) will take the preinstrumentation root canal sample (S1)
- Confirming the patency of the root canals using stainless steel hand K-files size #10 and #15 . Working length will be determined .
- In the intervention group, (R.S) will perform mechanical preparation in a 3D manner using Xp-endo Shaper single file in an endodontic motor at a speed of 800 rpm and a torque of 1 Ncm.
- In the control group, mechanical preparation will be done using rotary iRace files (#25/0.04, #30/0.04, and #40/0.04) at a speed of 600 rpm and a torque of 1.5 Ncm. The canal will be irrigated and recapitulated after the use of each instrument.
- EDTA gel will be used as a lubricant. The canals will be thoroughly irrigated using 3ml of 2.5% sodium hypochlorite.
- The canal will then be dried by using sterile paper points and then flushed with 5 ml of 5% sodium thiosulfate to inactivate the NaOCl. The postinstrumentation sample (S2) will be taken from the canals.
- Master cones will be fitted to the working length and a radiograph will be taken to ensure proper length.
- (R.S) will complete obturation using AdSeal resin-based root canal sealer .
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 Shaper | Experimental | Device: XP-endo ShaperThe XP-endo Shaper is an innovative single instrument manufactured from Max wire. Its special ability to shift crystalline structure at body temperature in order to adapt to the root canal wall, has provided a unique instrument with the promise of anatomical shaping. |
| iRace | Active comparator | Device: iRace filesrotary files |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy Adult patients.
- Age between 20-40 years old.
- Males \& Females.
- Asymptomatic necrotic mandibular premolars with or without periapical radiolucency.
- Normal occlusal contact with the opposing teeth.
Key exclusion criteria (8 listed)
- Medically compromised patients
- Pregnant women
- If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively
- Patients reporting bruxism or clenching
- Teeth that shows:
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 ShaperAlso: anatomical (3D) shaping filemechanical preparation in a 3D manner using Xp-endo Shaper | Device | XP-endo Shaper |
| iRace filesAlso: rotary filesrotary mechanical preparation | Device | iRace |
Primary outcome
Postoperative Pain
Time frame: up to 5 days
Degree of postoperative pain will be measured by the patients using modified VAS
2 secondary outcomes
intracanal bacterial reduction
Time frame: 6 hours
Incidence of analgesic intake
Time frame: up to 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- 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.
Radwa Emara principal investigator
faculty of oral and dental medicine - cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XP-endo Shaper and iRace files in people with Postoperative Pain, 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 6 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 18 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact radwa emara (01272141312, radwa.emara@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: up to 5 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 18 Sep 2017.