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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Other: Instrument Design

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: December 24, 2021
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: ENDO3-3-5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No