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Clinical Trials/NCT05305742
NCT05305742UnknownNot Applicable

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)

Cairo University0 sites56 target enrollmentStarted: April 1, 2022Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
56
Primary Endpoint
Post Operative Pain
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
22 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Protaper Ultimate

Experimental

Intervention: Instrument Design (Other)

Protaper Gold

Active Comparator

Intervention: Instrument Design (Other)

Outcomes

Primary Outcomes

Post Operative Pain

Time Frame: 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 Outcomes

  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Khaled Hassan Abed

Dentist / Master Degree Student at Faulty of Dentistry, Cairo University

Cairo University

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