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

Evaluation of Post Operative Pain After Using Two Different Types of Sealers (a Randomized Clinical Trial )

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

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Other: root canal sealers

Detailed Description

STUDY WILL BE PERFORMED ON PATIENTS DIAGNOSED WITH SYMPTOMATIC IRREVERSABE PULPITIS.

TREATMENT PROTOCOL FOR ALL PATIENTS IS CONVENTIONAL ROOT CANAL TREATMENT

ACCESS CAVITY AND CLEANING AND SHAPING PROCEDURES WILL BE EXECUTED FOR ALL PATIENTS WITH THE SAME PROTOCOL

SELECTED PATIENTS WILL THEN BE DIVIDED INTO TWO GROUPS,

GROUP1: ALL CANALS WILL BE OBTURATED USING RESIN STANDARD SEALERS.

GROUP2: ALL CANALS WILL BE OBTURATED USING HIGH FLOW BIOCERAMIC SEALERS THAT ACCEPT WARM VERTICAL COMPACTION

POST OPERATIVE PAIN IN THE TWO GROUPS WILL BE EVALUATED USING THE VISUAL ANALOUG SCALE AND COMPARED AT DIFFERENT TIME PERIODS (12H, 24H, 48H, 72H)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Recruiting
    • British University In Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • 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.

Exclusion Criteria:

• • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: resin group; obturated with resin sealer	Other: root canal sealers; different sealer used in obturating root canals (resin and bio ceramic); Other Names: bioceramic sealer
Active Comparator: bio ceramic group; obturated with bioceramic sealer	Other: root canal sealers; different sealer used in obturating root canals (resin and bio ceramic); Other Names: bioceramic sealer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: BritishUE sara

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: evaluated postoperative pain results when using different sealer types in obturation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No