Back to resultsEffect of Ultrasonic Activation of Bioceramic Sealer on Postoperative Pain in Lower Premolars
Primary Purpose
Symptomatic Irreversible Pulpitis
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasonic activation of bioceramic sealer
Sponsored by
About this trial
This is an interventional treatment trial for Symptomatic Irreversible Pulpitis
Eligibility Criteria
Inclusion Criteria:
- Patients above 18 years old and to 50.
- Male or female.
- Patients seeking root canal treatment.
- Mandibular posterior teeth with Symptomatic irreversible pulpitis with preoperative sharp, moderate, or severe pain with normal periapical radiographic appearance or slight widening in lamina dura.
- Systematically healthy patient (ASA I, II).
- Patient who can understand modified VAS and sign informed consent
Exclusion Criteria:
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- History of intolerance to NSAIDS.
- Patients with two or more adjacent teeth requiring endodontic treatment.
- External root resorption.
- Internal root resorption.
- Vertical root fracture.
- Periapical lesion.
- Association with swelling.
- Acute peri-apical abscess or acute exacerbation of a chronic abscess.
- Pregnancy.
- Use of ibuprofen in the last 12 hour.
- Bleeding disorder.
- Long term corticosteroid use.
- Mobility Grade II or III.
- Pocket depth more than 5mm.
- Previous root canal therapy.
- Non-restorability.
- TMJ problems, bruxism, clenching or traumatic occlusion.
- Inability to perceive the given instructions
Sites / Locations
- Cairo universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ultrasonic activation of bioceramic sealer
bioceramic sealer
Arm Description
ultrasonic activation of bioceramic sealer for 20 seconds
bioceramic sealer
Outcomes
Primary Outcome Measures
postoperative pain
intensity of pain on modified Visual analogue scale
postoperative pain
intensity of pain on modified Visual analogue scale
postoperative pain
intensity of pain on modified Visual analogue scale
postoperative pain
intensity of pain on modified Visual analogue scale
Secondary Outcome Measures
number of analgesic tablets taken by patient after endodontic treatment
number of analgesics taken by patient in 1st 48 hours
Sealer Extrusion laterally and periapically
presence or absence of sealer extrusion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05289791
Brief Title
Effect of Ultrasonic Activation of Bioceramic Sealer on Postoperative Pain in Lower Premolars
Official Title
The Effect of Ultrasonic Activation of Bioceramic Sealer on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to clinically compare post-operative pain levels after ultrasonic activation of Ceraseal bioceramic sealer versus non-activated bioceramic sealer for patients with symptomatic irreversible pulpitis related to mandibular premolar teeth.
Detailed Description
To clinically compare post-operative pain levels after ultrasonic activation of Ceraseal bioceramic sealer versus non-activated bioceramic sealer for patients with symptomatic irreversible pulpitis related to mandibular premolar teeth.Ultrasonic activation of Ceraseal bioceramic sealer for 20 seconds using non cutting ultrasonic tip.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Irreversible Pulpitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ultrasonic activation of bioceramic sealer
Arm Type
Experimental
Arm Description
ultrasonic activation of bioceramic sealer for 20 seconds
Arm Title
bioceramic sealer
Arm Type
Active Comparator
Arm Description
bioceramic sealer
Intervention Type
Other
Intervention Name(s)
ultrasonic activation of bioceramic sealer
Intervention Description
activation of bioceramic sealer using ultrasonic tip for 20 seconds in buccolingual and mesiodistal direction
Primary Outcome Measure Information:
Title
postoperative pain
Description
intensity of pain on modified Visual analogue scale
Time Frame
6 hours
Title
postoperative pain
Description
intensity of pain on modified Visual analogue scale
Time Frame
12 hours
Title
postoperative pain
Description
intensity of pain on modified Visual analogue scale
Time Frame
24 hours
Title
postoperative pain
Description
intensity of pain on modified Visual analogue scale
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
number of analgesic tablets taken by patient after endodontic treatment
Description
number of analgesics taken by patient in 1st 48 hours
Time Frame
up to 48 hours postoperatively
Title
Sealer Extrusion laterally and periapically
Description
presence or absence of sealer extrusion
Time Frame
Immediately after obturation.
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 above 18 years old and to 50.
Male or female.
Patients seeking root canal treatment.
Mandibular posterior teeth with Symptomatic irreversible pulpitis with preoperative sharp, moderate, or severe pain with normal periapical radiographic appearance or slight widening in lamina dura.
Systematically healthy patient (ASA I, II).
Patient who can understand modified VAS and sign informed consent
Exclusion Criteria:
Medically compromised patients having significant systemic disorders. (ASA III or IV).
History of intolerance to NSAIDS.
Patients with two or more adjacent teeth requiring endodontic treatment.
External root resorption.
Internal root resorption.
Vertical root fracture.
Periapical lesion.
Association with swelling.
Acute peri-apical abscess or acute exacerbation of a chronic abscess.
Pregnancy.
Use of ibuprofen in the last 12 hour.
Bleeding disorder.
Long term corticosteroid use.
Mobility Grade II or III.
Pocket depth more than 5mm.
Previous root canal therapy.
Non-restorability.
TMJ problems, bruxism, clenching or traumatic occlusion.
Inability to perceive the given instructions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bassant Y. El-saharty
Phone
01286858288
Email
bassantyasser@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Radwa S. Emara, lecturer
Phone
0127141312
Email
radwa.emara@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba M. El-far, professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Cairo university
City
Giza
State/Province
Manial
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Effect of Ultrasonic Activation of Bioceramic Sealer on Postoperative Pain in Lower Premolars
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