Clinical trial NCT03285334: 3D Instrumentation Versus Rotary Instrumentation
Official title: The Effect of 3D Instrumentation Versus Rotary Instrumentation on Postoperative Pain and Bacterial Reduction in Necrotic Oval Canals: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain
timeFrame: up to 5 days
Secondary outcomes:
measure: intracanal bacterial reduction
timeFrame: 6 hours
measure: Incidence of analgesic intake
timeFrame: up to 5 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine - Cairo University
state: Manial
Study officials:
affiliation: faculty of oral and dental medicine - cairo university
name: Radwa Emara
role: PRINCIPAL_INVESTIGATOR
References: