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CompletedNCT03743987Updated Feb 25, 2019

The Effect of MTA and PRF Application in Periapical Lesions

An interventional study of control group and MTA group in Apical Periodontitis and Wound Heal, sponsored by Recep Tayyip Erdogan University Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-25.

Sponsored by Recep Tayyip Erdogan University Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Dec 2016, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Apical Periodontitis
  • Wound Heal
03

In context

Periapical Periodontitis

256 studies on the registry are indexed under Periapical Periodontitis; 65 are open to participants now.

This study's enrollment of 36 is below the median of 60 across 222 interventional studies indexed under Periapical Periodontitis.

Browse Periapical Periodontitis studies →

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital is the lead sponsor of 88 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Sham comparator
    control group

    Apical resection group. Only root resection was applied without any other interventions (like prf or mta)

    Procedure: control group

  • Experimental
    MTA group

    Root resection was applied and MTA was inserted through the apical foramen

    Procedure: MTA group

  • Experimental
    PRF group

    Root resection was applied and PRF was placed to the surgically prepared area

    Procedure: PRF group

  • 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

Interventions

  • Procedurecontrol group

    a procedure used to prevent or resolves apical periodontitis.

    Also known as: root resection

  • ProcedureMTA group

    a procedure used to prevent or resolves apical periodontitis.

    Also known as: mineral trioxide aggregate

  • ProcedurePRF group

    a procedure that is used for wound healing

    Also known as: platelet rich fibrin

  • ProcedureMTA + PRF group

    a procedure used to prevent or resolves apical periodontitis in combination with a procedure that is used for wound healing.

    Also known as: mineral trioxide aggregate + mineral trioxide aggregate

06

What researchers measure

Primary outcomes

  1. Radiographic success - in volume

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

    Time frame: 1 year

  2. Radiographic success - in density

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

    Time frame: 1 year

07

Study locations

1 site
  • Nazife Begüm KARAN
    Ankara, Merkez 83TR2WATUF, Turkey (Türkiye)
08

References and documents

Publications

  • Karan NB, Aricioglu B. Assessment of bone healing after mineral trioxide aggregate and platelet-rich fibrin application in periapical lesions using cone-beam computed tomographic imaging. Clin Oral Investig. 2020 Feb;24(2):1065-1072. doi: 10.1007/s00784-019-03003-x. Epub 2019 Jul 18. PubMed 31321573 ↗

Individual participant data

Plan to share: No — data can be available 6 months after the acceptance of the paper

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03743987
Lead sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Responsible party
Nazife Begüm KARAN (Assistant Professor, DDS, PhD, Recep Tayyip Erdogan University Training and Research Hospital) — Principal investigator
First posted
Nov 16, 2018
Start date
Dec 20, 2016
Primary completion
Nov 5, 2018
Completion
Nov 5, 2018
Last update
Feb 25, 2019

Study contacts

Nazife Begüm KARAN, PhD, DDS
principal investigator · Recep Tayyip Erdogan University
Banu Arıcıoğlu, PhD, DDS
principal investigator · Recep Tayyip Erdogan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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