Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2017-11-30
2018-11-30
Brief Summary
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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
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the operator will complete treatment of all cases in single visit as following:
1. Anesthetizing the tooth using inferior alveolar nerve block technique
2. Removal of Caries and/or coronal restorations completely with sterile bur and rubber dam will be applied.
3. Preparation of access cavity using another sterile round carbide bur size 3 and Endo-z bur .
4. (R.S) will take the preinstrumentation root canal sample (S1)
5. Confirming the patency of the root canals using stainless steel hand K-files size #10 and #15 . Working length will be determined .
6. 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.
7. 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.
8. EDTA gel will be used as a lubricant. The canals will be thoroughly irrigated using 3ml of 2.5% sodium hypochlorite.
9. 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.
10. Master cones will be fitted to the working length and a radiograph will be taken to ensure proper length.
11. (R.S) will complete obturation using AdSeal resin-based root canal sealer .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
* The patients who already do not know their treatment group will assess the level of their post-operative pain and will record the number of analgesic tablets used.
* The laboratory technician at the microbiological department will not know the treatment group of the patients.
Study Groups
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XP-endo Shaper
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.
XP-endo Shaper
mechanical preparation in a 3D manner using Xp-endo Shaper
iRace
rotary files
iRace files
rotary mechanical preparation
Interventions
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XP-endo Shaper
mechanical preparation in a 3D manner using Xp-endo Shaper
iRace files
rotary mechanical preparation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age between 20-40 years old.
3. Males \& Females.
4. Asymptomatic necrotic mandibular premolars with or without periapical radiolucency.
5. Normal occlusal contact with the opposing teeth.
6. Patients accepting to participate in the study.
Exclusion Criteria
2. Pregnant women
3. If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively
4. Patients reporting bruxism or clenching
5. Teeth that shows:
* Association with acute periapical abscess and swelling
* Greater than grade I mobility or pocket depth greater than 5mm
* No restorability
20 Years
45 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Radwa Sameeh Emara
assisstant lecturer
Principal Investigators
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Radwa Emara
Role: PRINCIPAL_INVESTIGATOR
faculty of oral and dental medicine - cairo university
Locations
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Faculty of Oral and Dental Medicine - Cairo University
Cairo, Manial, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CEBD-CU-2017-09-19
Identifier Type: -
Identifier Source: org_study_id