Back to resultsPain After PRP Revascularization and Endodontic Treatment of Non-vital Mandibular Molars With Apical Periodontitis
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Platelet rich plasma PRP
root canal treatment
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Medically free patients, between 18-40 years
- Patients with necrotic pulp in mandibular molar permanent teeth with closed apex
Exclusion Criteria:
- Illiterate patient
- Patients with systemic diseases
- Pregnant women
- Patients that have allergy to ciprofloxacin or metronidazole
Teeth that:
- Have vertical root fracture, coronal perforation, and calcification.
- re-treatment cases
- Non restorable
- Patients that have T.M.J. disorder
Sites / Locations
- Yassmin Elsayed Ahmed
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Revascularization
root canal treatment
Arm Description
platelet rich plasma injected in the canals
endodontic treatment obturated with gutta percha
Outcomes
Primary Outcome Measures
Post-operative Pain
postoperative pain evaluated using NRS scale It is a numerical rating scale from 0-10 with 0 representing no pain and 10 representing worst pain
Secondary Outcome Measures
healing
healing of periapical tissue evaluated radiographically
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03350841
Brief Title
Pain After PRP Revascularization and Endodontic Treatment of Non-vital Mandibular Molars With Apical Periodontitis
Official Title
Evaluation of Post-operative Pain Following Platelet Rich Plasma (PRP) Revascularization Versus Conventional Endodontic Treatment of Non-vital Mature Mandibular Molars With Chronic Peri-apical Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
randomized clinical trial which Evaluate thr Post-operative Pain Following Platelet Rich Plasma (PRP) Revascularization versus Conventional Endodontic Treatment of Non-vital Mature Mandibular Molars with Chronic Peri-apical Periodontitis
Detailed Description
it will be done in 2 visits where in the firist visit, i will finish cleaning and shaping of the canals and inject double antibiotic paste as intracanal medication.
in the second visit, removal of intracanal medication then obturaton of the canals in the control group. while in the intervention group,over instrumentation of the canals beyond the working length using k-file size 20-35 to establish bleeding in the canals.then blood sample is collected for PRP preparation then injected into the canal.the patient will record post operative pain 6,12,24,48 hours then 3,4,5 days later.then they will do CBCT at 6, 12 months after the treatment to assess peri-apical healing
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Revascularization
Arm Type
Experimental
Arm Description
platelet rich plasma injected in the canals
Arm Title
root canal treatment
Arm Type
Active Comparator
Arm Description
endodontic treatment obturated with gutta percha
Intervention Type
Procedure
Intervention Name(s)
Platelet rich plasma PRP
Intervention Description
blood sample is collected to prepare platelet rich plasma injected in the canal
Intervention Type
Procedure
Intervention Name(s)
root canal treatment
Intervention Description
conventional root canal treatment and obturation with guttapercha
Primary Outcome Measure Information:
Title
Post-operative Pain
Description
postoperative pain evaluated using NRS scale It is a numerical rating scale from 0-10 with 0 representing no pain and 10 representing worst pain
Time Frame
5 days
Secondary Outcome Measure Information:
Title
healing
Description
healing of periapical tissue evaluated radiographically
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Medically free patients, between 18-40 years
Patients with necrotic pulp in mandibular molar permanent teeth with closed apex
Exclusion Criteria:
Illiterate patient
Patients with systemic diseases
Pregnant women
Patients that have allergy to ciprofloxacin or metronidazole
Teeth that:
Have vertical root fracture, coronal perforation, and calcification.
re-treatment cases
Non restorable
Patients that have T.M.J. disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yassmin ahmed
Phone
00201006088594
Email
yassmin.ahmed@dentistry.cu.edu.eg
Facility Information:
Facility Name
Yassmin Elsayed Ahmed
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yassmin ahmed
Phone
00201006088594
Email
yassmin.ahmed@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
radwa emara
Phone
00201272141312
Email
radwa.emara@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pain After PRP Revascularization and Endodontic Treatment of Non-vital Mandibular Molars With Apical Periodontitis
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