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

Primary Purpose

Post Operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
root canal sealers
Sponsored by
British University In Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • British university in egyptRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

resin group

bio ceramic group

Arm Description

obturated with resin sealer

obturated with bioceramic sealer

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 5, 2023
Last Updated
February 13, 2023
Sponsor
British University In Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT05729893
Brief Title
Evaluation of Post Operative Pain After Using Two Different Types of Sealers
Official Title
Evaluation of Post Operative Pain After Using Two Different Types of Sealers (a Randomized Clinical Trial )
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
British University In Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
resin group
Arm Type
Active Comparator
Arm Description
obturated with resin sealer
Arm Title
bio ceramic group
Arm Type
Active Comparator
Arm Description
obturated with bioceramic sealer
Intervention Type
Other
Intervention Name(s)
root canal sealers
Other Intervention Name(s)
bioceramic sealer
Intervention Description
different sealer used in obturating root canals (resin and bio ceramic)
Primary Outcome Measure Information:
Title
Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 12 hours
Description
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.
Time Frame
12 hours
Title
Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 24 hours
Description
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.
Time Frame
24 hours
Title
Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 48 hours
Description
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.
Time Frame
48 hours
Title
Pain level comparison after root canal obturation with two different endodontic sealers: VAS (Visual Analogue Scale) at 72 hours
Description
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.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sara tarek mohamed, bachelor
Phone
01007434392
Email
sara.alsayed@bue.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
hala F khalil, lecturer
Phone
01287595795
Email
hala.fayek@bue.edu.eg
Facility Information:
Facility Name
British university in egypt
City
Cairo
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sara tarek mohamed, bachelor
Phone
01007434392
Email
sara.alsayed@bue.edu.eg
First Name & Middle Initial & Last Name & Degree
hala fayek khalil, lecturer
Phone
01287595795
Email
hala.fayek@bue.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
evaluated postoperative pain results when using different sealer types in obturation

Learn more about this trial

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

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