Pain After PRP Revascularization and Endodontic Treatment of Non-vital Mandibular Molars With Apical Periodontitis

November 29, 2017 updated by: yassmin Elsayed Ahmed, Cairo University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Revascularization
platelet rich plasma injected in the canals
Procedure: Platelet rich plasma PRP
blood sample is collected to prepare platelet rich plasma injected in the canal
ACTIVE_COMPARATOR: root canal treatment
endodontic treatment obturated with gutta percha
Procedure: root canal treatment
conventional root canal treatment and obturation with guttapercha

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Pain
Time Frame: 5 days
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
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
healing
Time Frame: 12 months
healing of periapical tissue evaluated radiographically
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

November 16, 2017

First Submitted That Met QC Criteria

November 18, 2017

First Posted (ACTUAL)

November 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 29, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2017-11-27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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