NCT02528240

Brief Summary

This study evaluates the effect of leucocyte and platelet rich fibrin (L-PRF) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing. Also the influence of an occlusive membrane barrier in EMS on the periapical bone healing will be studied. The trial design is an open randomized controlled clinical trial with a 2x2 factorial design. Half of the participants will receive EMS with L-PRF (experimental group), the other half without (control group). The control and experimental group will be divided in 2 subsequent groups: half of the participants will receive an occlusive membrane during EMS, the other half not.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

1.3 years

First QC Date

August 14, 2015

Last Update Submit

November 3, 2020

Conditions

Periapical Periodontitis

Keywords

platelets

Outcome Measures

Primary Outcomes (1)

  • Patient related outcomes

    Assessed with a Visual Analog Scale

    7 days

Secondary Outcomes (1)

  • Patient related outcomes

    7 days

Other Outcomes (5)

  • Amount of periapical bone healing in time

    4 years

  • Timeframe in which the cortical bone plate closes

    1 year

  • Bone or scar tissue healing

    4 years

  • +2 more other outcomes

Study Arms (2)

+ L-PRF

EXPERIMENTAL

With leukocyte and platelet rich fibrin

Procedure: EMSDevice: + occlusive membraneDevice: conebeam CT

- L-PRF

ACTIVE COMPARATOR

Without leukocyte and platelet rich fibrin

Procedure: EMSDevice: conebeam CT

Interventions

EMSPROCEDURE
+ L-PRF- L-PRF
+ occlusive membraneDEVICE
+ L-PRF
conebeam CTDEVICE
+ L-PRF- L-PRF

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of Informed Consent
  • Patients in need of an EMS
  • EMS is the only option to cure the periapical lesion

You may not qualify if:

  • Unlikely to be able to comply with the study procedures, as judged by the investigator
  • Orthograde endodontic (re)treatment is indicated
  • Known or suspected current malignancy
  • History of chemotherapy within 5 years prior to study
  • History of radiation in the head and neck region
  • History of other metabolic bone diseases
  • History of bleeding disorders
  • HIV disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 19, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2020

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

BE(1)