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

Not Applicable

• Conditions: Post Operative Pain
• Interventions: Other: Instrument Design

• Registration Number: NCT05305742
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-24
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-30
• Last Update Submitted: 2022-03-30
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31
• Study Start: 2022-04-01
• Primary Completion: 2023-01-31
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protaper Gold	Instrument Design	-
Protaper Ultimate	Instrument Design	-

Primary Outcome Measures

Name	Time	Method
Post Operative 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.	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

Secondary Outcome Measures

Name	Time	Method
Number of needed analgesic tablets in case of intolerable pain	Patient will be contacted after 48 hours after endodontic treatment to know the number of analgesic tablets taken	The patient will record the number of analgesic tablets taken in case of intolerable pain
Antibacterial Effectiveness	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.	Bacterial counting using agar Culture technique