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NCT Number: NCT02528240

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

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.

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Key information

Conditions

Periapical Periodontitis Jaw Diseases Mouth Diseases Periapical Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMS

Procedure

+ occlusive membrane

Device

conebeam CT

Device

Primary outcomes

  1. Patient related outcomes

    Time frame: 7 days

    Assessed with a Visual Analog Scale

Secondary outcomes

  1. Patient related outcomes

    Time frame: 7 days

    Assessed with a questionnaire

Other outcomes

  1. Amount of periapical bone healing in time

    Time frame: 4 years

    Assessed with conebeam CT and periapical radiography

  2. Timeframe in which the cortical bone plate closes

    Time frame: 1 year

    Assessed with echography

  3. Bone or scar tissue healing

    Time frame: 4 years

    Assessed with conebeam CT

  4. Dentinal defects

    Time frame: 1 day

    Assessed with a LED light source

  5. Type of periapical tissue

    Time frame: 7 days

    Assessed by biopsy

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2020
First posted
Aug 19, 2015
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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