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

NCT ID: NCT05305742

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Operative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Protaper Ultimate

Group Type EXPERIMENTAL

Instrument Design

Intervention Type OTHER

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

Protaper Gold

Group Type ACTIVE_COMPARATOR

Instrument Design

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Instrument Design

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Khaled Hassan Abed

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ENDO3-3-5

Identifier Type: -

Identifier Source: org_study_id