Evaluation of Post Operative Pain After Using Two Different Types of Sealers

NCT05729893 | Unknown

• 1 other identifier: BritishUE sara
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

conventional endodontic treatment is done using two different types of sealers in the obturation to evaluate the post operative pain between the two sealers

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (4)

• Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 12 hours

  Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  12 hours

• Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 24 hours

  Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  24 hours

• Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 48 hours

  Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  48 hours

• Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 72 hours

  Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  72 hours

Study Arms (2)

resin group

ACTIVE COMPARATOR

obturated with resin sealer

Other: root canal sealers

bio ceramic group

ACTIVE COMPARATOR

obturated with bioceramic sealer

Other: root canal sealers

Interventions

root canal sealers OTHER

different sealer used in obturating root canals (resin and bio ceramic)

Also known as: bioceramic sealer

bio ceramic group; resin group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients age ranges from 18-50 years old.
• Patients with teeth diagnosed with symptomatic irreversible pulpitis.
• Normal periapical condition confirmed by normal periapical radiograph or that with minimal widening of the PDL space
• The teeth are restorable
• Teeth are periodontally free.

You may not qualify if:

• Teeth with immature roots
• Non restorable teeth
• Medically compromised patients with systemic complication that would alter the treatment.
• Necrotic teeth
• Teeth with apical periodontitis or periapical lesions
• Teeth that need multiple visits treatment

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

British university in egypt

Cairo, 02, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

sara tarek mohamed, bachelor

CONTACT

01007434392; sara.alsayed@bue.edu.eg

hala F khalil, lecturer

CONTACT

01287595795; hala.fayek@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients were randomly divided into two groups according to material used for obturation . each patients name will be replaced with a case number within the group to protect the privacy of medical information and data of the patients care provider and the investigator will not know the name of the patient and the assessor doesn't know the group he is assessing
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: randomized clinical trial

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: February 15, 2023
• Study Start: February 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)