Effect of Different Rotary Files Systems on Post-operative Pain and Bacterial Reduction in Lower Single Canal Posterior Teeth With Necrotic Pulp: Prospective Double Blinded Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Postoperative pain
Study Overview
Brief Summary
Postoperative pain after endodontic treatment can affect a patient's quality of life. It is reported that debris extrusion after the instrumentation technique can influence postoperative pain. As a result, the aim of this clinical trial is to compare the recent rotary systems (TruNatomy, ProTaper Ultimate, Hyflex EDM and XP- rise rotary files systems) in terms of apical extrusion defined by post-operative pain and their role in reducing the bacterial count inside the canal
Detailed Description
One hundred and twenty lower premolar teeth will be included in the study(n=120). Teeth will be randomly assigned to one of the 4 groups(n=30). Preoprative pain will be recorded before root canal treatment. Postoperative pain will be recorded using visual analogue scale (VAS) at 6 hours,12 hours, 1day, 2 days, 3 days, 4 dayse and five days after the root canal treatment. Bacterial count before and after instrumentation will be determined using culturing methods to determine the bacterial count reduction.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Medically fit
- •Age ranges from 18-65 year
- •Restorable teeth
- •Necrotic teeth and symptoms free
- •Lower premolars teeth (single canal posterior teeth)
- •Necrotic pulps
Exclusion Criteria
- •Medically compromised
- •Non-restorable teeth
- •Open apex canal
- •The past 12-hour history of analgesic intake before treatment.
- •Patients with a history of antibiotics intake in the last 3 months before treatment.
- •Pregnant females.
- •Symptomatic patient.
- •Pulpal diagnosis is not necrotic pulp.
- •Retreatment cases
Arms & Interventions
Single file system: Hyflex EDM
Intervention: Hyflex EDM (Other)
Multifile system: Protaper Ultimate
Intervention: Protaper ultimate (Other)
Multiple files systems:TruNatomy
Intervention: Truanatomy file system (Other)
Single file system: Xp shaper rise
Intervention: Xp shaper rise (Other)
Outcomes
Primary Outcomes
Postoperative pain
Time Frame: at 6hours,12 hours, 24 hours, 2 days, 3 days, 4 days and five days after the root canal treatment
Postoperative pain will be recorded using Visual Analogue Scale (VAS) at 6hours,12 hours, 24 hours, 2 days, 3 days, 4 days and five days after the root canal treatment Visual Analogue Scale (VAS) ranges from 0-10, the lower number the better outcome. 0= no pain 1-3= mild pain 4-6= moderate pain 7-10= sever pain
Bacterial count reduction
Time Frame: Sample will be collected before and directly after canal prepeartion
Bacterial count sample will be collected before and after canal prepeartion
Secondary Outcomes
No secondary outcomes reported
Investigators
Ruba Mustafa
Professor associate
King Abdullah University Hospital