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The Effect of MTA and PRF Application in Periapical Lesions

R

Recep Tayyip Erdogan University Training and Research Hospital

Status

Completed

Conditions

Apical Periodontitis
Wound Heal

Treatments

Procedure: MTA + PRF group
Procedure: PRF group
Procedure: MTA group
Procedure: control group

Study type

Interventional

Funder types

Other

Identifiers

NCT03743987
RTEU 107

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

36 participants in 4 patient groups

control group
Sham Comparator group
Description:
Apical resection group. Only root resection was applied without any other interventions (like prf or mta)
Treatment:
Procedure: control group
MTA group
Experimental group
Description:
Root resection was applied and MTA was inserted through the apical foramen
Treatment:
Procedure: MTA group
PRF group
Experimental group
Description:
Root resection was applied and PRF was placed to the surgically prepared area
Treatment:
Procedure: PRF group
MTA + PRF group
Experimental group
Description:
Root resection was applied. MTA was inserted through the apical foramen and PRF was placed to the surgically prepared area
Treatment:
Procedure: MTA + PRF group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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