Endodontic Microsurgery With the Use of L-PRF and an Occl... | NCT02528240

Studies
Endodontic Microsurgery With the Use of L-PRF and an Occlusive Membrane: a Randomized Controlled Clinical Trial

NCT02528240

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Nov 5, 2020Actual

Enrollment

56Actual

Phase

Not Applicable

Conditions

Periapical Periodontitis

Interventions

EMS
+ occlusive membrane
conebeam CT

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Jun 2020Actual

First Submitted Date

Aug 14, 2015

First Submission Date that Met QC Criteria

Aug 18, 2015

First Posted Date

Aug 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2020

Last Update Posted Date

Nov 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
+ L-PRF	Experimental	With leukocyte and platelet rich fibrin	Procedure: EMS Device: + occlusive membrane Device: conebeam CT
- L-PRF	Active Comparator	Without leukocyte and platelet rich fibrin	Procedure: EMS Device: conebeam CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EMS	Procedure		+ L-PRF - L-PRF
+ occlusive membrane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient related outcomes	Assessed with a Visual Analog Scale	7 days

Secondary Outcomes

Measure	Description	Time Frame
Patient related outcomes	Assessed with a questionnaire	7 days

Other Outcomes

Measure	Description	Time Frame
Amount of periapical bone healing in time	Assessed with conebeam CT and periapical radiography	4 years
Timeframe in which the cortical bone plate closes	Assessed with echography

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven		Leuven		3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D010485	Periapical Periodontitis

Ancestor Terms

ID	Term
D010483	Periapical Diseases
D007571	Jaw Diseases
D009057	Stomatognathic Diseases
D010510	Periodontal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided