Back to resultsEndodontic Microsurgery With the Use of L-PRF and an Occlusive Membrane: a Randomized Controlled Clinical Trial
Primary Purpose
Periapical Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
EMS
+ occlusive membrane
conebeam CT
Sponsored by
About this trial
This is an interventional treatment trial for Periapical Periodontitis focused on measuring platelets
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
Sites / Locations
- UZ Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
+ L-PRF
- L-PRF
Arm Description
With leukocyte and platelet rich fibrin
Without leukocyte and platelet rich fibrin
Outcomes
Primary Outcome Measures
Patient related outcomes
Assessed with a Visual Analog Scale
Secondary Outcome Measures
Patient related outcomes
Assessed with a questionnaire
Full Information
NCT ID
NCT02528240
First Posted
August 14, 2015
Last Updated
November 3, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT02528240
Brief Title
Endodontic Microsurgery With the Use of L-PRF and an Occlusive Membrane: a Randomized Controlled Clinical Trial
Official Title
Endodontic Microsurgery With the Use of L-PRF and an Occlusive Membrane: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
June 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Periodontitis
Keywords
platelets
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
+ L-PRF
Arm Type
Experimental
Arm Description
With leukocyte and platelet rich fibrin
Arm Title
- L-PRF
Arm Type
Active Comparator
Arm Description
Without leukocyte and platelet rich fibrin
Intervention Type
Procedure
Intervention Name(s)
EMS
Intervention Type
Device
Intervention Name(s)
+ occlusive membrane
Intervention Type
Device
Intervention Name(s)
conebeam CT
Primary Outcome Measure Information:
Title
Patient related outcomes
Description
Assessed with a Visual Analog Scale
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Patient related outcomes
Description
Assessed with a questionnaire
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Amount of periapical bone healing in time
Description
Assessed with conebeam CT and periapical radiography
Time Frame
4 years
Title
Timeframe in which the cortical bone plate closes
Description
Assessed with echography
Time Frame
1 year
Title
Bone or scar tissue healing
Description
Assessed with conebeam CT
Time Frame
4 years
Title
Dentinal defects
Description
Assessed with a LED light source
Time Frame
1 day
Title
Type of periapical tissue
Description
Assessed by biopsy
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Endodontic Microsurgery With the Use of L-PRF and an Occlusive Membrane: a Randomized Controlled Clinical Trial
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