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Clinical Trials/NCT02528240
NCT02528240CompletedNot Applicable

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

Universitaire Ziekenhuizen KU Leuven2 sites in 1 country56 target enrollmentStarted: August 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
56
Locations
2
Primary Endpoint
Patient related outcomes
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Patient related outcomes

Time Frame: 7 days

Assessed with a Visual Analog Scale

Secondary Outcomes

  • Patient related outcomes(7 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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