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OpenTrials
Completed

NCT Number: NCT03743987

The Effect of MTA and PRF Application in Periapical Lesions

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nazife Begüm KARAN

Ankara, Merkez, 83TR2WATUF, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Group

Procedure

a procedure used to prevent or resolves apical periodontitis.

Other names: root resection

MTA group

Procedure

a procedure used to prevent or resolves apical periodontitis.

Other names: mineral trioxide aggregate

PRF group

Procedure

a procedure that is used for wound healing

Other names: platelet rich fibrin

MTA + PRF group

Procedure

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

Primary outcomes

  1. Radiographic success - in volume

    Time frame: 1 year

    Evaluation of tomographic outcomes (differences between preoperative and postoperative volume of periapical lesions)

  2. Radiographic success - in density

    Time frame: 1 year

    Evaluation of tomographic outcomes (differences between preoperative and postoperative density of periapical lesions)

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 16, 2018
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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