An interventional study of XP-endo Shaper and iRace files in Postoperative Pain, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-18.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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:
Exclusion criteria:
Teeth that shows:
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.
Device: XP-endo Shaper
rotary files
Device: iRace files
mechanical preparation in a 3D manner using Xp-endo Shaper
Also known as: anatomical (3D) shaping file
rotary mechanical preparation
Also known as: rotary files
Postoperative Pain
Degree of postoperative pain will be measured by the patients using modified VAS
Time frame: up to 5 days
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.
Time frame: 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)
Time frame: up to 5 days
Plan to share: No
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Cairo University