The Effect of MTA and PRF Application in Periapical Lesions
Assessment of Bone Healing After MTA and PRF Application in Periapical Lesions By Using CBCT
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2018
CompletedFirst Submitted
Initial submission to the registry
November 14, 2018
CompletedFirst Posted
Study publicly available on registry
November 16, 2018
CompletedFebruary 25, 2019
February 1, 2019
1.9 years
November 14, 2018
February 21, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Radiographic success - in volume
Evaluation of tomographic outcomes (differences between preoperative and postoperative volume of periapical lesions)
1 year
Radiographic success - in density
Evaluation of tomographic outcomes (differences between preoperative and postoperative density of periapical lesions)
1 year
Study Arms (4)
control group
SHAM COMPARATORApical resection group. Only root resection was applied without any other interventions (like prf or mta)
MTA group
EXPERIMENTALRoot resection was applied and MTA was inserted through the apical foramen
PRF group
EXPERIMENTALRoot resection was applied and PRF was placed to the surgically prepared area
MTA + PRF group
EXPERIMENTALRoot resection was applied. MTA was inserted through the apical foramen and PRF was placed to the surgically prepared area
Interventions
a procedure used to prevent or resolves apical periodontitis.
a procedure used to prevent or resolves apical periodontitis.
a procedure that is used for wound healing
a procedure used to prevent or resolves apical periodontitis in combination with a procedure that is used for wound healing.
Eligibility Criteria
You may qualify if:
- Single rooted canals
- Failed previous root canal treatment
- Retreatment at least 1 year previously
- Previous surgery with unresolved bony lesion
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nazife Begüm KARAN
Ankara, Merkez, 83TR2WATUF, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 31321573DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nazife Begüm KARAN, PhD, DDS
Recep Tayyip Erdogan University
- PRINCIPAL INVESTIGATOR
Banu Arıcıoğlu, PhD, DDS
Recep Tayyip Erdogan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, DDS, PhD
Study Record Dates
First Submitted
November 14, 2018
First Posted
November 16, 2018
Study Start
December 20, 2016
Primary Completion
November 5, 2018
Study Completion
November 5, 2018
Last Updated
February 25, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share
data can be available 6 months after the acceptance of the paper