The Effect of 3D Instrumentation Versus Rotary Instrumentation on Postoperative Pain and Bacterial Reduction in Necrotic Oval Canals: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Postoperative Pain
Study Overview
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:
- Anesthetizing the tooth using inferior alveolar nerve block technique
- Removal of Caries and/or coronal restorations completely with sterile bur and rubber dam will be applied.
- Preparation of access cavity using another sterile round carbide bur size 3 and Endo-z bur .
- (R.S) will take the preinstrumentation root canal sample (S1)
- Confirming the patency of the root canals using stainless steel hand K-files size #10 and #15 . Working length will be determined .
- 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.
- 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.
- EDTA gel will be used as a lubricant. The canals will be thoroughly irrigated using 3ml of 2.5% sodium hypochlorite.
- 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.
- Master cones will be fitted to the working length and a radiograph will be taken to ensure proper length.
- (R.S) will complete obturation using AdSeal resin-based root canal sealer .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, 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 Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy Adult patients.
- •Age between 20-40 years old.
- •Males & Females.
- •Asymptomatic necrotic mandibular premolars with or without periapical radiolucency.
- •Normal occlusal contact with the opposing teeth.
- •Patients accepting to participate in the study.
- •Exclusion criteria:
- •Medically compromised patients
- •Pregnant women
- •If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively
- •Patients reporting bruxism or clenching
- •Teeth that shows:
- •Association with acute periapical abscess and swelling
- •Greater than grade I mobility or pocket depth greater than 5mm
- •No restorability
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: XP-endo Shaper (Device)
iRace
rotary files
Intervention: iRace files (Device)
Outcomes
Primary Outcomes
Postoperative Pain
Time Frame: up to 5 days
Degree of postoperative pain will be measured by the patients using modified VAS
Secondary Outcomes
- intracanal bacterial reduction(6 hours)
- Incidence of analgesic intake(up to 5 days)
Investigators
Radwa Sameeh Emara
assisstant lecturer
Cairo University