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The Effect of MTA and PRF Application in Periapical Lesions

Primary Purpose

Apical Periodontitis, Wound Heal

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
control group
MTA group
PRF group
MTA + PRF group
Sponsored by
Recep Tayyip Erdogan University Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apical Periodontitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Nazife Begüm KARAN

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Experimental

Experimental

Experimental

Arm Label

control group

MTA group

PRF group

MTA + PRF group

Arm Description

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

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

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

Root resection was applied. MTA was inserted through the apical foramen and PRF was placed to the surgically prepared area

Outcomes

Primary Outcome Measures

Radiographic success - in volume
Evaluation of tomographic outcomes (differences between preoperative and postoperative volume of periapical lesions)
Radiographic success - in density
Evaluation of tomographic outcomes (differences between preoperative and postoperative density of periapical lesions)

Secondary Outcome Measures

Full Information

First Posted
November 14, 2018
Last Updated
February 21, 2019
Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03743987
Brief Title
The Effect of MTA and PRF Application in Periapical Lesions
Official Title
Assessment of Bone Healing After MTA and PRF Application in Periapical Lesions By Using CBCT
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 20, 2016 (Actual)
Primary Completion Date
November 5, 2018 (Actual)
Study Completion Date
November 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Recep Tayyip Erdogan University Training and Research Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis, Wound Heal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Sham Comparator
Arm Description
Apical resection group. Only root resection was applied without any other interventions (like prf or mta)
Arm Title
MTA group
Arm Type
Experimental
Arm Description
Root resection was applied and MTA was inserted through the apical foramen
Arm Title
PRF group
Arm Type
Experimental
Arm Description
Root resection was applied and PRF was placed to the surgically prepared area
Arm Title
MTA + PRF group
Arm Type
Experimental
Arm Description
Root resection was applied. MTA was inserted through the apical foramen and PRF was placed to the surgically prepared area
Intervention Type
Procedure
Intervention Name(s)
control group
Other Intervention Name(s)
root resection
Intervention Description
a procedure used to prevent or resolves apical periodontitis.
Intervention Type
Procedure
Intervention Name(s)
MTA group
Other Intervention Name(s)
mineral trioxide aggregate
Intervention Description
a procedure used to prevent or resolves apical periodontitis.
Intervention Type
Procedure
Intervention Name(s)
PRF group
Other Intervention Name(s)
platelet rich fibrin
Intervention Description
a procedure that is used for wound healing
Intervention Type
Procedure
Intervention Name(s)
MTA + PRF group
Other Intervention Name(s)
mineral trioxide aggregate + mineral trioxide aggregate
Intervention Description
a procedure used to prevent or resolves apical periodontitis in combination with a procedure that is used for wound healing.
Primary Outcome Measure Information:
Title
Radiographic success - in volume
Description
Evaluation of tomographic outcomes (differences between preoperative and postoperative volume of periapical lesions)
Time Frame
1 year
Title
Radiographic success - in density
Description
Evaluation of tomographic outcomes (differences between preoperative and postoperative density of periapical lesions)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazife Begüm KARAN, PhD, DDS
Organizational Affiliation
Recep Tayyip Erdogan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Banu Arıcıoğlu, PhD, DDS
Organizational Affiliation
Recep Tayyip Erdogan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nazife Begüm KARAN
City
Ankara
State/Province
Merkez
ZIP/Postal Code
83TR2WATUF
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
data can be available 6 months after the acceptance of the paper
Citations:
PubMed Identifier
31321573
Citation
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.
Results Reference
derived

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The Effect of MTA and PRF Application in Periapical Lesions

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