The Effect of MTA and PRF Application in Periapical Lesions

February 21, 2019 updated by: Nazife Begüm KARAN, Recep Tayyip Erdogan University Training and Research Hospital

Assessment of Bone Healing After MTA and PRF Application in Periapical Lesions By Using CBCT

A total of 40 periapical lesions from the 33 patient undergoing apical surgery were randomly selected from December 2016-November 2017. Patients were informed about the surgical procedure and signed a consent form. Groups were divided in to 4; as control, MTA (mineral trioxide aggregate), PRF (platelet rich fibrin) and MTA+PRF groups. Apical resection was performed in all groups. No other interventions were made to the control group.

Routine radiographs were taken in the 1st. 3th and 6th months. In the (approximately) 12th month of the procedures computerized tomography scans were taken. Primary healing of the periapical tissues were evaluated and the outcomes were measured. Patients have still been under control for the long term outcomes of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

44 apically infected periapical lesions were decided to enroll to the study from December 2016-November 2017. However; a total of 40 periapical lesions undergoing apical surgery were recruited for the planned clinical trial in the end. The study was conducted under randomized controlled protocol. Patients were informed about the surgical procedures and signed a consent form. The anticipated outcomes, possible risks and benefits of the study as well as the alternative treatment options were explained to the patients.

Groups were designed to have 10 patients in each and randomly divided into four as; control, MTA, PRF and MTA+PRF. Apical resection was performed in all groups. No other interventions were made to the control group.

Routine radiographs were taken in the 1st. 3th and 6th months. In the 12th month of the procedures computerized tomography (CT) scans were taken. Primary healing of the periapical tissues were evaluated according to the volumes and the densities of the lesions. Outcomes were measured. Comparison between the initial and the last 3D CT scan volumes were made by medical image processing software (MIMICS, Belgium). Patients have still been under control for the long term outcomes of the study.

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Turkey
    • Merkez
      • Ankara, Merkez, Turkey, 83TR2WATUF
        • Nazife Begüm Karan

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

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Single rooted canals
  • Failed previous root canal treatment
  • Retreatment at least 1 year previously
  • Previous surgery with unresolved bony lesion

Exclusion Criteria:

  • More than single rooted canals
  • Chronic generalized periodontitis
  • Any systemic disease contraindicating oral surgical procedures
  • Evidence of root fracture
  • Resorptive processes involving more than apical third of the root

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
SHAM_COMPARATOR: control group
Apical resection group. Only root resection was applied without any other interventions (like prf or mta)
Procedure: control group
a procedure used to prevent or resolves apical periodontitis.
Other Names:
  • root resection
EXPERIMENTAL: MTA group
Root resection was applied and MTA was inserted through the apical foramen
Procedure: MTA group
a procedure used to prevent or resolves apical periodontitis.
Other Names:
  • mineral trioxide aggregate
EXPERIMENTAL: PRF group
Root resection was applied and PRF was placed to the surgically prepared area
Procedure: PRF group
a procedure that is used for wound healing
Other Names:
  • platelet rich fibrin
EXPERIMENTAL: MTA + PRF group
Root resection was applied. MTA was inserted through the apical foramen and PRF was placed to the surgically prepared area
Procedure: MTA + PRF group
a procedure used to prevent or resolves apical periodontitis in combination with a procedure that is used for wound healing.
Other Names:
  • mineral trioxide aggregate + mineral trioxide aggregate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic success - in volume
Time Frame: 1 year
Evaluation of tomographic outcomes (differences between preoperative and postoperative volume of periapical lesions)
1 year
Radiographic success - in density
Time Frame: 1 year
Evaluation of tomographic outcomes (differences between preoperative and postoperative density of periapical lesions)
1 year

Collaborators and Investigators

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

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Investigators

  • Principal Investigator: Nazife Begüm KARAN, PhD, DDS, Recep Tayyip Erdogan University
  • Principal Investigator: Banu Arıcıoğlu, PhD, DDS, Recep Tayyip Erdogan 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 (ACTUAL)

December 20, 2016

Primary Completion (ACTUAL)

November 5, 2018

Study Completion (ACTUAL)

November 5, 2018

Study Registration Dates

First Submitted

November 14, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (ACTUAL)

November 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTEU 107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data can be available 6 months after the acceptance of the paper

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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