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

Post Operative Pain Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05305742
• Other study ID #: ENDO3-3-5
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: February 28, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of needed analgesic tablets in case of intolerable pain	The patient will record the number of analgesic tablets taken in case of intolerable pain	Patient will be contacted after 48 hours after endodontic treatment to know the number of analgesic tablets taken
Secondary	Antibacterial Effectiveness	Bacterial counting using agar Culture technique	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.