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

NCT ID: NCT02528240

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2020-06-30

Brief Summary

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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

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Conditions

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Periapical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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+ L-PRF

With leukocyte and platelet rich fibrin

Group Type EXPERIMENTAL

EMS

Intervention Type PROCEDURE

+ occlusive membrane

Intervention Type DEVICE

conebeam CT

Intervention Type DEVICE

- L-PRF

Without leukocyte and platelet rich fibrin

Group Type ACTIVE_COMPARATOR

EMS

Intervention Type PROCEDURE

conebeam CT

Intervention Type DEVICE

Interventions

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EMS

Intervention Type PROCEDURE

+ occlusive membrane

Intervention Type DEVICE

conebeam CT

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S58015 / B322201525314/ I / U

Identifier Type: -

Identifier Source: org_study_id