Evaluation of Postoperative Pain and Bacterial Load Reduction With ProTaper Ultimate Versus ProTaper Gold Rotary Systems

Study Overview
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Brief Summary
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This study aims to research the effect of different instrument designs by comparing protaper ultimate versus protaper gold systems on root canal preparation by evaluating bacterial count reduction and post-operative pain following single visit treatment in patients with necrotic pulp in maxillary premolar teeth.

Official Title
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Evaluation of Postoperative Pain and Bacterial Load Reduction After Canal Preparation With ProTaper Ultimate Versus ProTaper Gold Rotary Systems in Patients With Necrotic Maxillary Premolars (Randomized Clinical Trial)

Conditions
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Post Operative Pain

Intervention / Treatment
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* Other: Instrument Design


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient's age ranges between 22 to 45 years with no sex predilection. Medically free patients. Maxillary permanent premolar teeth: Diagnosed clinically with pulp necrosis. Absence of pain. Radiographic evidence of two roots or single root with double canals. Slight widening in the periodontal membrane space or with peri-apical radiolucency No response to cold pulp tester and ethyl chloride spray. Patients who can understand Modified Visual Analogue Scale (VAS). Patients' acceptance to participate in the trial. Exclusion Criteria: Medically compromised patients. Pregnant women. If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively. Patients reporting bruxism or clenching. Teeth with: i. Vital teeth. ii. Single canal maxillary premolar teeth iii. Association with swelling or fistulous tract. iv. Acute peri-apical abscess and swelling. v. Mobility Grade II or III. vi. Pocket depth more than 5mm. vii. Previous root canal therapy. viii. Non-restorable teeth: Hopeless tooth Immature teeth. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification, root caries.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protaper Ultimate<br> | Other: Instrument Design<br>* Research the effect of different instrument designs on root canal preparation by evaluating bacterial count reduction and post-operative pain<br>|
| Active Comparator: Protaper Gold<br> | Other: Instrument Design<br>* Research the effect of different instrument designs on root canal preparation by evaluating bacterial count reduction and post-operative pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Pain | Intensity of pain felt after endodontic treatment recorded by the patient using modified Visual Analogue Scale where 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain | Postoperative pain will be measured by modified Visual Analogue Scale immediately after the end of treatment, and at 6, 12, 24 and 48 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of needed analgesic tablets in case of intolerable pain | The patient will record the number of analgesic tablets taken in case of intolerable pain | Patient will be contacted after 48 hours after endodontic treatment to know the number of analgesic tablets taken | 
| Antibacterial Effectiveness | Bacterial counting using agar Culture technique | First as a Baseline (T0): After the access cavity Sample 1 will be taken, after 15 minutes (T1) mechanical instrumentation will be done and Sample 2 will be taken, after 5 minutes from T1 (T2) final irrigation will be done and Sample 3 will be taken. |