Clinical trial NCT03743987: 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
Overall status: COMPLETED
Phase: NA
Conditions: Apical Periodontitis
Wound Heal
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Radiographic success - in volume
timeFrame: 1 year
measure: Radiographic success - in density
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Nazife Begüm KARAN
state: Merkez
Study officials:
affiliation: Recep Tayyip Erdogan University
name: Nazife Begüm KARAN, PhD, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Recep Tayyip Erdogan University
name: Banu Arıcıoğlu, PhD, DDS
role: PRINCIPAL_INVESTIGATOR
References:
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.