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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03350841
Other study ID # CEBD-CU-2017-11-27
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 16, 2017
Last updated November 29, 2017
Start date January 2018
Est. completion date December 2019

Study information

Verified date November 2017
Source Cairo University
Contact yassmin ahmed
Phone 00201006088594
Email yassmin.ahmed@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date December 2019
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 35 Years
Eligibility 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 Design


Intervention

Procedure:
Platelet rich plasma PRP
blood sample is collected to prepare platelet rich plasma injected in the canal
root canal treatment
conventional root canal treatment and obturation with guttapercha

Locations

Country Name City State
Egypt Yassmin Elsayed Ahmed Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 5 days
Secondary healing healing of periapical tissue evaluated radiographically 12 months
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