Periapical PeriodontitisNCT02528240
Endodontic Microsurgery With the Use of L-PRF and an Occlusive Membrane: a Randomized Controlled Clinical Trial
A study testing EMS, + occlusive membrane and conebeam CT in people with Periapical Periodontitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Periapical Periodontitis
- What is being tested?
- EMS, + occlusive membrane and conebeam CT
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2015to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provision of Informed Consent
- Patients in need of an EMS
- EMS is the only option to cure the periapical lesion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Periapical Periodontitis
- Being tested
- EMS, + occlusive membrane, conebeam CT
- Keywords
- platelets
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMSProcedure or surgery
+ occlusive membraneDevice
conebeam CTDevice
| Study group | Role | What they receive |
|---|---|---|
| + L-PRF | Experimental | With leukocyte and platelet rich fibrin Receives: Procedure: EMS; Device: + occlusive membrane; Device: conebeam CT |
| - L-PRF | Active comparator | Without leukocyte and platelet rich fibrin Receives: Procedure: EMS; Device: conebeam CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient related outcomes
Assessed with a Visual Analog Scale
Measured: 7 days
Secondary outcomes (1)
Patient related outcomes
Assessed with a questionnaire
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528240
- Sponsor's protocol ID
- S58015 / B322201525314/ I / U
- Status last verified
- Nov 2020
- First submitted
- 14 Aug 2015
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endodontic Microsurgery With the Use of L-PRF and an Occlusive Membrane: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02528240
- Acronym / sponsor ID
- S58015 / B322201525314/ I / U
- Conditions
- Periapical Periodontitis
- Keywords
- platelets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| + L-PRF | Experimental | Procedure: EMS, Device: + occlusive membrane, Device: conebeam CTWith leukocyte and platelet rich fibrin |
| - L-PRF | Active comparator | Procedure: EMS, Device: conebeam CTWithout leukocyte and platelet rich fibrin |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of Informed Consent
- Patients in need of an EMS
- EMS is the only option to cure the periapical lesion
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMS | Procedure or surgery | + L-PRF, - L-PRF |
| + occlusive membrane | Device | + L-PRF |
| conebeam CT | Device | + L-PRF, - L-PRF |
Primary outcome
Patient related outcomes
Time frame: 7 days
Assessed with a Visual Analog Scale
1 secondary outcome
Patient related outcomes
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMS, + occlusive membrane and conebeam CT in people with Periapical Periodontitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient related outcomes (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.