Effect of Apical Enlargement to Different Preparation Sizes and Tapers on Pain and Bacterial Reduction in Necrotic Pulp

Not Applicable

Not yet recruiting

• Conditions: Necrotic Pulp

• Registration Number: NCT05620147
• Lead Sponsor: Cairo University

Brief Summary

The aim of this prospective randomized clinical trial is to evaluate the effect of different apical size and taper preparation (35. 04; 35. 06; 45. 04 and 45. 06) on postoperative pain at 6, 12, 24, 48 and 72 hours, and intra-canal bacterial count in patients having mandibular premolars with necrotic pulps.

Detailed Description

* Patients will be clinically and radiographically examined and their eligibility will be assessed. Eligible patients will be treated in one visit.

* Patients will be randomly assigned to one of 4 groups: experimental groups of root canal instrumentation with EdgeFile X7 to size #35/0.06 or #45/0.04 or #45/0.06 or the comparator group to size #35/0.04. Intra-canal bacterial count will be measured using a culture technique. Bacterial samples will be taken before and after root canal instrumentation. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 400 mg as rescue medication.

* Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed at 6, 12, 24, 48 and 72 hours postoperatively using Numerical Rating Scale (NRS).

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-08
• Last Update Submitted: 2022-11-16
• Study First Posted: 2022-11-17
• Last Update Posted: 2022-11-21
• Study Start: 2023-01
• Primary Completion: 2023-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Systemically healthy patients, American Society of Anesthesiologists (ASA) I and II.
• Patient's age ranges between 18 to 35 years with no sex predilection.
• Patients with single-rooted mandibular premolars with asymptomatic necrotic pulp.
• Patients who can understand the Numerical Rating Scale (NRS).
• Patients able to sign informed consent.

Exclusion Criteria

• Pregnant females.
• Mandibular premolars with periodontal pockets greater than 5 mm or greater than grade I mobility.
• Patients have a positive history of antibiotic use or analgesic use within the past week or required antibiotic premedication for dental treatment (such as prosthetic joint prophylaxis).
• Patients have teeth that have been previously accessed.
• Teeth with extensive crown destruction by caries that will not permit rubber dam placement.
• Teeth associated with acute periapical abscess, swelling or a fistulous tract.
• Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post-operative pain	up to 72 hours after endodontic treatment	Postendodontic pain will be measured using Numerical Rating Scale. The Numerical Rating Scale consists of a 0-10 scale, with (0) meaning "no pain" and (10) meaning "the worst pain imaginable". No or mild pain response will be considered success.

Secondary Outcome Measures

Name	Time	Method
Intra-canal bacterial reduction	Bacterial samples will be taken Immediately after root canal instrumentation.	Intra-canal bacterial count will be measured using a culture technique. The resultant growth will be visually quantified by counting the number of colony forming units per millilitre (CFUs/ mL)