NCT03743987

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

1.9 years

First QC Date

November 14, 2018

Last Update Submit

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 COMPARATOR

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

Procedure: control group

MTA group

EXPERIMENTAL

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

Procedure: MTA group

PRF group

EXPERIMENTAL

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

Procedure: PRF group

MTA + PRF group

EXPERIMENTAL

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

control groupPROCEDURE

a procedure used to prevent or resolves apical periodontitis.

Also known as: root resection
control group
MTA groupPROCEDURE

a procedure used to prevent or resolves apical periodontitis.

Also known as: mineral trioxide aggregate
MTA group
PRF groupPROCEDURE

a procedure that is used for wound healing

Also known as: platelet rich fibrin
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
MTA + PRF group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

Location

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.

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Control GroupsApicoectomymineral trioxide aggregatePemetrexed

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsOral Surgical ProceduresSurgical Procedures, OperativeEndodonticsDentistryGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Nazife Begüm KARAN, PhD, DDS

    Recep Tayyip Erdogan University

    PRINCIPAL INVESTIGATOR
  • Banu Arıcıoğlu, PhD, DDS

    Recep Tayyip Erdogan University

    PRINCIPAL INVESTIGATOR

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

Locations