Apical PeriodontitisNCT05379010
Endodontic Microsurgery With the Use of L-PRF Block
A study testing Endodontic Microsurgery in people with Apical Periodontitis and Apical Periodontal Cyst, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This study evaluates the effect of leucocyte and platelet rich fibrin Block (L-PRF Block) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing in large peri-apical lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apical Periodontitis, Apical Periodontal Cyst
- What is being tested?
- Endodontic Microsurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Aug 2020to 31 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of Informed Consent
- Patients from 18 years old
- Patients in need of an EMS
- EMS is the only option to cure the periapical lesion
- A periapical lesion that has a diameter of 10mm or more in sagittal plane, frontal plane or axial plane when measured on CBCT
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
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- History of bleeding disorders
- HIV disease
- Hepatitis B or C
- Systemic disease (osteoporosis, diabetes…)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endodontic Microsurgery With the Use of L-PRF Block: a Randomized Controlled Clinical Trial
This study evaluates the effect of leucocyte and platelet rich fibrin Block (L-PRF Block) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing in large peri-apical lesions.
Read the detailed description
This study evaluates the effect of leucocyte and platelet rich fibrin Block (L-PRF Block) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing in large peri-apical lesions. The trial design is an open randomized controlled clinical trial with two groups. Half of the participants will receive EMS with L-PRF Block (experimental group), the other half without (control group).
- Conditions
- Apical Periodontitis, Apical Periodontal Cyst
- Being tested
- Endodontic Microsurgery
- Medical subject headings
- Periapical Periodontitis, Radicular Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodontic MicrosurgeryProcedure or surgery
Surgical removal of 3 millimeters of the root-end, removal of the apical pathology, Root-end preparation and retrograde filling. The entire procedure is done under magnification.
| Study group | Role | What they receive |
|---|---|---|
| With L-PRF Block | Experimental | Not described Receives: Procedure: Endodontic Microsurgery |
| No L-PRF Block | Active comparator | Not described Receives: Procedure: Endodontic Microsurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of peri-apical bone healing
Amount of periapical bone healing in time: measured with Cone Beam Computed Tomography (CBCT).
Measured: 1 year
Secondary outcomes (6)
Patient related outcomes
Pain assessed with a Visual Analogue Scale ranging from 0 to 10 each day during the first 7 days post-op.
Measured: 7 days
Patient related outcomes
Pain assessed with a questionnaire asking about analgesics usage each day during 7 days post-op.
Measured: 7 days
Patient related outcomes
Discomfort assessed with a Visual Analogue Scale ranging from 1 to 5 each day during the first 7 days post-op.
Measured: 7 days
Bone or scar tissue healing
Bone or scar tissue healing: Volumetric analysis using Cone-Beam Computed Tomography. Pre-operative CBCT data will be matched with the post-op CBCT scans in order to assess the volumetric changes during 1 year.
Measured: 1 year
Success & survival rate
Success \& survival rate
Measured: 1 year
Dentinal defects
Dentinal defects: in the apical root before and after resection. Potential cracks and fractures that occur during the follow-up period will be assessed on CBCT en reported.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start3 Aug 2020
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nastaran Meschi, DDS, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379010
- Sponsor's protocol ID
- S63971
- Status last verified
- Sep 2023
- First submitted
- 22 Apr 2022
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endodontic Microsurgery With the Use of L-PRF Block: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05379010
- Acronym / sponsor ID
- S63971
- Conditions
- Apical Periodontitis, Apical Periodontal Cyst
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 18 May 2022 (actual)
- 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 Block (L-PRF Block) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing in large peri-apical lesions.
Detailed description
This study evaluates the effect of leucocyte and platelet rich fibrin Block (L-PRF Block) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing in large peri-apical lesions. The trial design is an open randomized controlled clinical trial with two groups. Half of the participants will receive EMS with L-PRF Block (experimental group), the other half without (control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With L-PRF Block | Experimental | Procedure: Endodontic Microsurgery |
| No L-PRF Block | Active comparator | Procedure: Endodontic Microsurgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of Informed Consent
- Patients from 18 years old
- Patients in need of an EMS
- EMS is the only option to cure the periapical lesion
- A periapical lesion that has a diameter of 10mm or more in sagittal plane, frontal plane or axial plane when measured on CBCT
Key exclusion criteria (10 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 |
|---|---|---|
| Endodontic MicrosurgerySurgical removal of 3 millimeters of the root-end, removal of the apical pathology, Root-end preparation and retrograde filling. The entire procedure is done under magnification. | Procedure or surgery | No L-PRF Block, With L-PRF Block |
Primary outcome
Amount of peri-apical bone healing
Time frame: 1 year
Amount of periapical bone healing in time: measured with Cone Beam Computed Tomography (CBCT).
6 secondary outcomes
Patient related outcomes
Time frame: 7 days
Patient related outcomes
Time frame: 7 days
Patient related outcomes
Time frame: 7 days
Bone or scar tissue healing
Time frame: 1 year
Success & survival rate
Time frame: 1 year
Dentinal defects
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Nastaran Meschi, DDS principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endodontic Microsurgery in people with Apical Periodontitis and Apical Periodontal Cyst, 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 15 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nastaran Meschi, PhD (0032476313889 ext. +32, Nastaran.meschi@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of peri-apical bone healing (time frame: 1 year). 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 15 Sep 2023.