Effect of Apical Enlargement to Different Preparation Sizes and Tapers on Pain and Bacterial Reduction in Necrotic Pulp

Study Overview
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Brief Summary
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The aim of this prospective randomized clinical trial is to evaluate the effect of different apical size and taper preparation (35. 04; 35. 06; 45. 04 and 45. 06) on postoperative pain at 6, 12, 24, 48 and 72 hours, and intra-canal bacterial count in patients having mandibular premolars with necrotic pulps.

Detailed Description
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Patients will be clinically and radiographically examined and their eligibility will be assessed. Eligible patients will be treated in one visit. Patients will be randomly assigned to one of 4 groups: experimental groups of root canal instrumentation with EdgeFile X7 to size #35/0.06 or #45/0.04 or #45/0.06 or the comparator group to size #35/0.04. Intra-canal bacterial count will be measured using a culture technique. Bacterial samples will be taken before and after root canal instrumentation. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 400 mg as rescue medication. Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed at 6, 12, 24, 48 and 72 hours postoperatively using Numerical Rating Scale (NRS).

Official Title
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Effect of Apical Third Enlargement to Different Preparation Sizes and Tapers of EdgeFile X7 on Postoperative Pain and Intra-canal Bacterial Reduction in Patients With Necrotic Pulp: A Randomized Clinical Trial

Conditions
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Necrotic Pulp

Intervention / Treatment
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* Other: Root canal instrumentation EdgeFile X7 to size #35/0.06
* Other: Root canal instrumentation EdgeFile X7 to size #45/0.04
* Other: Root canal instrumentation EdgeFile X7 to size #45/0.06
* Other: Root canal instrumentation EdgeFile X7 to size #35/0.04


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy patients, American Society of Anesthesiologists (ASA) I and II. Patient's age ranges between 18 to 35 years with no sex predilection. Patients with single-rooted mandibular premolars with asymptomatic necrotic pulp. Patients who can understand the Numerical Rating Scale (NRS). Patients able to sign informed consent. Exclusion Criteria: Pregnant females. Mandibular premolars with periodontal pockets greater than 5 mm or greater than grade I mobility. Patients have a positive history of antibiotic use or analgesic use within the past week or required antibiotic premedication for dental treatment (such as prosthetic joint prophylaxis). Patients have teeth that have been previously accessed. Teeth with extensive crown destruction by caries that will not permit rubber dam placement. Teeth associated with acute periapical abscess, swelling or a fistulous tract. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Root canal instrumentation EdgeFile X7 to size #35/0.06<br>The mechanical preparation will be continued using EdgeFile X7 #35 .04 and #35 .06 | Other: Root canal instrumentation EdgeFile X7 to size #35/0.06<br>* Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm<br>* Other names: EdgeEndo;|
| Experimental: Root canal instrumentation EdgeFile X7 to size #45/0.04<br>The mechanical preparation will be continued using EdgeFile X7 #35 .04, #40 .04 and #45 .04 | Other: Root canal instrumentation EdgeFile X7 to size #45/0.04<br>* Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm<br>* Other names: EdgeEndo;|
| Experimental: Root canal instrumentation EdgeFile X7 to size #45/0.06<br>The mechanical preparation will be continued using EdgeFile X7 #35 .04, #40 .04, #45 .04 and #45 .06 | Other: Root canal instrumentation EdgeFile X7 to size #45/0.06<br>* Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm<br>* Other names: EdgeEndo;|
| Active Comparator: Root canal instrumentation EdgeFile X7 to size #35/0.04<br>The mechanical preparation will be continued using EdgeFile X7 #35 .04 | Other: Root canal instrumentation EdgeFile X7 to size #35/0.04<br>* Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm<br>* Other names: EdgeEndo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | Postendodontic pain will be measured using Numerical Rating Scale. The Numerical Rating Scale consists of a 0-10 scale, with (0) meaning no pain and (10) meaning the worst pain imaginable. No or mild pain response will be considered success. | up to 72 hours after endodontic treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-canal bacterial reduction | Intra-canal bacterial count will be measured using a culture technique. The resultant growth will be visually quantified by counting the number of colony forming units per millilitre (CFUs/ mL) | Bacterial samples will be taken Immediately after root canal instrumentation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apical enlargement, Postoperative pain, Intra-canal bacterial reduction, Preparation taper, EdgeFile X7