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

NCT05305742 | Unknown DMC

• 1 other identifier: ENDO3-3-5
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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.

Study Arms (2)

Protaper Ultimate

EXPERIMENTAL

Other: Instrument Design

Protaper Gold

ACTIVE COMPARATOR

Other: Instrument Design

Interventions

Instrument Design OTHER

Research the effect of different instrument designs on root canal preparation by evaluating bacterial count reduction and post-operative pain

Protaper Gold; Protaper Ultimate

Eligibility Criteria

• Age: 22 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist / Master Degree Student at Faulty of Dentistry, Cairo University

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: March 31, 2022
• Study Start: April 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: February 28, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03