3D Instrumentation Versus Rotary Instrumentation

Cairo University (CU)

Status: Unknown

Conditions: Postoperative Pain

Treatments: Device: XP-endo Shaper; Device: iRace files

Study type: Interventional

Funder types: Other

Identifiers

NCT03285334

CEBD-CU-2017-09-19

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

XP-endo Shaper

Experimental group

Description:

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.

Treatment:

Device: XP-endo Shaper

iRace

Active Comparator group

Description:

rotary files

Treatment:

Device: iRace files