Back to resultsPost Operative Pain of Partial Pulpotomy Using a Bioceramic Material in Patients With Symptomatic Irreversible Pulpitis
Primary Purpose
Endodontic Disease
Status
Recruiting
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Partial pulpotomy
Sponsored by
About this trial
This is an interventional treatment trial for Endodontic Disease focused on measuring bioceramic material, pulpitis, partial pulpotomy
Eligibility Criteria
Inclusion criteria : Subject's age between 9-14 years. Both male and female subjects. Medically free and healthy subjects. Mandibular molar teeth. Teeth with symptomatic irreversible pulpitis. Teeth with mature closed apices. Exclusion Criteria: Teeth with acute dentoalveolar abscess. Subjects having more than one tooth that require root canal treatment. Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment. Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance. Teeth with periodontal disease or pulp calcification. Subjects taking chronic pain medications.
Sites / Locations
- Faculty of Dentistry, October 6 UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Control: conventional root canal treatment
Test: partial pulpotomy
Arm Description
Partial pulpotomy using bioceramic putty
Outcomes
Primary Outcome Measures
Post operative pain
Measure intensity of post operative pain using visual analogue scale (VAS)
Post operative pain
Measure intensity of post operative pain using visual analogue scale (VAS)
Post operative pain
Measure intensity of post operative pain using visual analogue scale (VAS)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05956613
Brief Title
Post Operative Pain of Partial Pulpotomy Using a Bioceramic Material in Patients With Symptomatic Irreversible Pulpitis
Official Title
Post Operative Pain of Partial Pulpotomy Using a Newly Introduced Bioceramic Material in Young Patients With Symptomatic Irreversible Pulpitis: A Double Blind Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
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
The goal of this clinical trial is to assess post-operative pain of partial pulpotomy using a newly introduced Bioceramic material in young patients with symptomatic irreversible pulpitis at 24, 48, 72 hours postoperatively using visual analogue scale (VAS). The main question[s] it aims to answer are:
• In patients with symptomatic irreversible pulpitis does the use of bioceramic material in partial pulpotomy decrease amount of post operative pain in comparison to conventional root canal treatment?
Participants will record the intensity of pain at 24,48, 72 hours postoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Disease
Keywords
bioceramic material, pulpitis, partial pulpotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control: conventional root canal treatment
Arm Type
No Intervention
Arm Title
Test: partial pulpotomy
Arm Type
Other
Arm Description
Partial pulpotomy using bioceramic putty
Intervention Type
Procedure
Intervention Name(s)
Partial pulpotomy
Intervention Description
Use of newly introduced bioceramic putty in partial pulpotomy
Primary Outcome Measure Information:
Title
Post operative pain
Description
Measure intensity of post operative pain using visual analogue scale (VAS)
Time Frame
after 24 hours
Title
Post operative pain
Description
Measure intensity of post operative pain using visual analogue scale (VAS)
Time Frame
after 48 hours
Title
Post operative pain
Description
Measure intensity of post operative pain using visual analogue scale (VAS)
Time Frame
After 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria :
Subject's age between 9-14 years.
Both male and female subjects.
Medically free and healthy subjects.
Mandibular molar teeth.
Teeth with symptomatic irreversible pulpitis.
Teeth with mature closed apices.
Exclusion Criteria:
Teeth with acute dentoalveolar abscess.
Subjects having more than one tooth that require root canal treatment.
Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment.
Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance.
Teeth with periodontal disease or pulp calcification.
Subjects taking chronic pain medications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Omaia, PhD
Phone
00201224474609
Email
mohamed.omaia.den@o6u.edu.eg
Facility Information:
Facility Name
Faculty of Dentistry, October 6 University
City
Giza
ZIP/Postal Code
12573
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
faculty of dentistry october 6 university
Phone
+20238355276
Email
dent@o6u.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post Operative Pain of Partial Pulpotomy Using a Bioceramic Material in Patients With Symptomatic Irreversible Pulpitis
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