The Effect of MTA and PRF Application in Periapical Lesions

Wound Heal Clinical Trial

Official title:

Assessment of Bone Healing After MTA and PRF Application in Periapical Lesions By Using CBCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743987
• Other study ID #: RTEU 107
• Status: Completed
• Phase: N/A
• Start date: December 20, 2016
• Est. completion date: November 5, 2018

Study information

• Verified date: February 2019
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 5, 2018
• Est. primary completion date: November 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Apical Periodontitis
• Periapical Periodontitis
• Periodontitis
• Wound Heal

Intervention

Procedure:
• control group
a procedure used to prevent or resolves apical periodontitis.
• MTA group
a procedure used to prevent or resolves apical periodontitis.
• PRF group
a procedure that is used for wound healing
• MTA + PRF group
a procedure used to prevent or resolves apical periodontitis in combination with a procedure that is used for wound healing.

Locations

Country	Name	City	State
Turkey	Nazife Begüm KARAN	Ankara	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic success - in volume	Evaluation of tomographic outcomes (differences between preoperative and postoperative volume of periapical lesions)	1 year
Primary	Radiographic success - in density	Evaluation of tomographic outcomes (differences between preoperative and postoperative density of periapical lesions)	1 year