Assessment of Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Using Two Revascularization Protocols. (In Vivo Study)

November 6, 2019 updated by: Ahmed Ali, Minia University
Regenerative endodontic procedures have been used to successfully treat human mature permanent teeth with necrotic pulps and apical periodontitis. Many researchers have begun to apply regenerative endodontic procedures to mature teeth in adult patients. Several clinical case reports have shown complete resolution of signs and symptoms of pulp necrosis in mature teeth, even those with large periapical lesions, as well as signs of pulp canal obliteration. thevaim of this study is To assess the regenerative potential of mature permanent teeth with necrotic pulps with platelet-rich fibrin (PRF) and blood clot using radiographic and clinical methods.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

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

11 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with mature teeth.
  • Patients with periapical periodontitis.
  • Maxillary anterior teeth only will be involved.
  • Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
  • Patients who will agree to the consent and will commit to follow up period.

Exclusion Criteria:

  • Patients with immature roots.
  • Patients with any systemic disease that may affect normal healing.
  • Patients with swelling.
  • Pregnant females.
  • Patients who could/would not participate in a 1 year follow up.
  • Patients with fistula.
  • Patients with old age.
  • Teeth with periodontal involvement.
  • Teeth with vertical root fractures.
  • Unrestorable teeth.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Blood clotting protocol for pulp regeneration
pulp regeneration for mature teeth using blood clotting protocol
Other: Method
treatment of mature teeth with apical periodontitis
Experimental: platelet rich fibrin for pulp regeneration
pulp regeneration for mature teeth using platelet rich fibrin (PRF)
Other: Method
treatment of mature teeth with apical periodontitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical success
Time Frame: 9 months
pulp vitality testing using electric pulp tester which detect response of pulp to electric current
9 months
radiographic success
Time Frame: 9 months
healing of apical periodontitis by detecting change in apical radiolucency and absences of apical bone resorption
9 months

Collaborators and Investigators

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

Sponsor

Minia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 2, 2019

Primary Completion (Anticipated)

September 2, 2020

Study Completion (Anticipated)

November 2, 2020

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

November 6, 2019

First Posted (Actual)

November 8, 2019

Study Record Updates

Last Update Posted (Actual)

November 8, 2019

Last Update Submitted That Met QC Criteria

November 6, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 306

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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