NCT03350841

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

November 16, 2017

Last Update Submit

November 29, 2017

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • healing

    12 months

Study Arms (2)

Revascularization

EXPERIMENTAL

platelet rich plasma injected in the canals

Procedure: Platelet rich plasma PRP

root canal treatment

ACTIVE COMPARATOR

endodontic treatment obturated with gutta percha

Procedure: root canal treatment

Interventions

Platelet rich plasma PRPPROCEDURE

blood sample is collected to prepare platelet rich plasma injected in the canal

Revascularization
root canal treatmentPROCEDURE

conventional root canal treatment and obturation with guttapercha

root canal treatment

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Medically free patients, between 18-40 years
  • Patients with necrotic pulp in mandibular molar permanent teeth with closed apex

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yassmin Elsayed Ahmed

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

yassmin ahmed

CONTACT

00201006088594yassmin.ahmed@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant lecturer-endodontic department

Study Record Dates

First Submitted

November 16, 2017

First Posted

November 22, 2017

Study Start

January 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

December 2, 2017

Record last verified: 2017-11

Locations

EG(1)