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

Necrotic Pulp Clinical Trial

Official title:

Effect of Apical Third Enlargement to Different Preparation Sizes and Tapers of EdgeFile X7 on Postoperative Pain and Intra-canal Bacterial Reduction in Patients With Necrotic Pulp: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05620147
• Other study ID #: 2/11/2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: Cairo University
• Contact: Nermeen Ibrahim, Master's
• Phone: 01114323345
• Email: nermin.awadallah[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Hypertrophy
• Necrosis
• Necrotic Pulp

Intervention

Other:
• Root canal instrumentation EdgeFile X7 to size #35/0.06
Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
• Root canal instrumentation EdgeFile X7 to size #45/0.04
Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
• Root canal instrumentation EdgeFile X7 to size #45/0.06
Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
• Root canal instrumentation EdgeFile X7 to size #35/0.04
Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

Fatima S, Kumar A, Andrabi SMUN, Mishra SK, Tewari RK. Effect of Apical Third Enlargement to Different Preparation Sizes and Tapers on Postoperative Pain and Outcome of Primary Endodontic Treatment: A Prospective Randomized Clinical Trial. J Endod. 2021 Sep;47(9):1345-1351. doi: 10.1016/j.joen.2021.05.010. Epub 2021 May 29. — View Citation

Rodrigues RCV, Zandi H, Kristoffersen AK, Enersen M, Mdala I, Ørstavik D, Rôças IN, Siqueira JF Jr. Influence of the Apical Preparation Size and the Irrigant Type on Bacterial Reduction in Root Canal-treated Teeth with Apical Periodontitis. J Endod. 2017 Jul;43(7):1058-1063. doi: 10.1016/j.joen.2017.02.004. Epub 2017 May 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	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.	up to 72 hours after endodontic treatment
Secondary	Intra-canal bacterial reduction	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)	Bacterial samples will be taken Immediately after root canal instrumentation.