Postoperative Pain
Conditions
Brief 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. 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: 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 .
Interventions
DEVICEXP-endo Shaper
mechanical preparation in a 3D manner using Xp-endo Shaper
DEVICEiRace files
rotary mechanical preparation
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
* The patients will drag an envelope and will not know to which group they will be assigned. * 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Adult patients. 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
1. Medically compromised patients 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | up to 5 days | Degree of postoperative pain will be measured by the patients using modified VAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intracanal bacterial reduction | 6 hours | 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. |
| Incidence of analgesic intake | up to 5 days | 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) |
Countries
Egypt
Contacts
Primary Contactradwa emara
Outcome results
None listed