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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05305742
Enrollment
56
Registered
2022-03-31
Start date
2022-04-01
Completion date
2023-02-28
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

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.

Interventions

OTHERInstrument Design

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
22 Years to 45 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Post Operative PainPostoperative 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

MeasureTime frameDescription
Number of needed analgesic tablets in case of intolerable painPatient will be contacted after 48 hours after endodontic treatment to know the number of analgesic tablets takenThe patient will record the number of analgesic tablets taken in case of intolerable pain
Antibacterial EffectivenessFirst 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026