Periapical LesionsPhase 2EBRAAPUUNCT06734962
Evaluation of Bone Regeneration After Apical Surgery Using Advanced Platelet-rich Fibrin: Utilization of Ultrasound for the Assessment of Periapical Lesions
A Phase 2 study testing Apical surgery procedure using A-PRF and Apical surgery without using A-PRF in people with Periapical Lesions, run by Riga Stradins University at 1 site in Latvia.
Trial summary
The study examines the impact of advanced platelet-rich fibrin (A-PRF) on bone regeneration in apical surgery compared to standard methods. It highlights the effectiveness of ultrasound as a diagnostic tool for assessing periapical lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periapical Lesions
- What is being tested?
- Apical surgery procedure using A-PRF and Apical surgery without using A-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteLatvia
- Study dates
- 12 Sep 2021to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Adult patients with precisely defined periapical lesions related to maxillary or mandibular incisors and premolar teeth as a sequel to persistent endodontic infection
- Patients after root canal treatment/retreatment
- Patients with or without the sinus tract
- Patients with root perforations
- Patients with clinical cases deemed unsuitable for non-surgical endodontic intervention
- Patients with traumatic lesions clearly indicated for endodontic apical surgery.
Who cannot join
- Patients younger than 18 years
- Patients with lesions unrelated to the root apical area
- Patients in possession of vital teeth with radiolucency in the apical region
- Pregnant patients
- Patients with non-restorable teeth
- Patients with advanced periodontal disease
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- Patients with uncontrolled systemic health conditions
- Patients receiving bisphosphonate therapy
- Patients receiving orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The study examines the impact of advanced platelet-rich fibrin (A-PRF) on bone regeneration in apical surgery compared to standard methods. It highlights the effectiveness of ultrasound as a diagnostic tool for assessing periapical lesions. Eligible participants were adults with specific periapical lesions following root canal treatment failures. Exclusions included patients outside specific criteria, like those with advanced periodontal disease or undergoing orthodontic treatment. Participants were randomized into two groups: one receiving A-PRF to enhance bone regeneration and a control group without it. Both groups underwent apical surgery under magnification, with different postoperative protocols. The study involved radiological and ultrasonographic evaluations of lesion size and bone healing at baseline, 6 months, and 12 months, alongside blood analyses for Vitamin D and cholesterol level to assess their potential impact on healing.
- Conditions
- Periapical Lesions
- Being tested
- Apical surgery procedure using A-PRF, Apical surgery without using A-PRF
- Keywords
- Periapical healing, Apical Surgery, A-PRF, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apical surgery procedure using A-PRFProcedure or surgery
Participants will undergo an apical surgery procedure using A-PRF. Before the surgery and at follow-ups, patients will undergo comprehensive evaluation using clinical, radiological, and ultrasonographic techniques.
Apical surgery without using A-PRFProcedure or surgery
Participants will undergo an apical surgery procedure without using A-PRF. Patients will undergo comprehensive evaluation before the surgery and at follow-ups using clinical, radiological, and ultrasonographic techniques.
| Study group | Role | What they receive |
|---|---|---|
| Control group (Without A-PRF) | Other | During the surgery procedure A-PRF application is not intended. Receives: Procedure: Apical surgery without using A-PRF |
| Test group ( With A-PRF) | Experimental | During the surgery procedure A-PRF application is intended. Receives: Procedure: Apical surgery procedure using A-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric bone volume healing assessment
Volumetric analysis of CBCT images will segment the defect in axial, sagittal, and coronal views. Bone volume will be measured in cubic millimeters (mm³) at pre-operative, 6-month, and 12-month follow-ups and compared between each other. Where 0 is - no periapical lesion/periapical lesion healed.
Measured: Baseline, 6 and 12 month
Secondary outcomes (1)
Asessment of Ultrasound diagnostic accuracy for periapical lesion measurment
During the baseline assessment, the dimensions of periapical lesions will be measured in millimeters and using the classification:
Category 1: no discernible periapical lesion was identified; Category 2: a periapical lesion was possibly present, however, the distinction was equivocal; Category 3: a periapical lesion was definitively observed. not unequivocal; Category 3: a periapical lesion was definitively observed. These measurements will then be analyzed in relation to images obtained through periapical radiography as well as those from cone beam computed tomography (CBCT). This comparison aims to evaluate the accuracy and reliability of different imaging techniques in assessing the size of periapical lesions.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start12 Sep 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical LesionsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riga Stradins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Karkle, Riga Stradins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734962
- Sponsor's protocol ID
- 22-2/427/2021
- Acronym
- EBRAAPUU
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Regeneration After Apical Surgery Using Advanced Platelet-rich Fibrin: Utilization of Ultrasound for the Assessment of Periapical Lesions
- ClinicalTrials.gov ID
- NCT06734962
- Acronym / sponsor ID
- EBRAAPUU / 22-2/427/2021
- Conditions
- Periapical Lesions
- Keywords
- Periapical healing, Apical Surgery, A-PRF, Ultrasound
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riga Stradins UniversityUniversity, hospital or other
- Study start
- 12 Sep 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 16 Dec 2024 (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.
The study examines the impact of advanced platelet-rich fibrin (A-PRF) on bone regeneration in apical surgery compared to standard methods. It highlights the effectiveness of ultrasound as a diagnostic tool for assessing periapical lesions. Eligible participants were adults with specific periapical lesions following root canal treatment failures. Exclusions included patients outside specific criteria, like those with advanced periodontal disease or undergoing orthodontic treatment. Participants were randomized into two groups: one receiving A-PRF to enhance bone regeneration and a control group without it. Both groups underwent apical surgery under magnification, with different postoperative protocols. The study involved radiological and ultrasonographic evaluations of lesion size and bone healing at baseline, 6 months, and 12 months, alongside blood analyses for Vitamin D and cholesterol level to assess their potential impact on healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (Without A-PRF) | Other | Procedure: Apical surgery without using A-PRFDuring the surgery procedure A-PRF application is not intended. |
| Test group ( With A-PRF) | Experimental | Procedure: Apical surgery procedure using A-PRFDuring the surgery procedure A-PRF application is intended. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients with precisely defined periapical lesions related to maxillary or mandibular incisors and premolar teeth as a sequel to persistent endodontic infection
- Patients after root canal treatment/retreatment
- Patients with or without the sinus tract
- Patients with root perforations
- Patients with clinical cases deemed unsuitable for non-surgical endodontic intervention
Key exclusion criteria (9 listed)
- Patients younger than 18 years
- Patients with lesions unrelated to the root apical area
- Patients in possession of vital teeth with radiolucency in the apical region
- Pregnant patients
- Patients with non-restorable teeth
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 |
|---|---|---|
| Apical surgery procedure using A-PRFParticipants will undergo an apical surgery procedure using A-PRF. Before the surgery and at follow-ups, patients will undergo comprehensive evaluation using clinical, radiological, and ultrasonographic techniques. | Procedure or surgery | Test group ( With A-PRF) |
| Apical surgery without using A-PRFParticipants will undergo an apical surgery procedure without using A-PRF. Patients will undergo comprehensive evaluation before the surgery and at follow-ups using clinical, radiological, and ultrasonographic techniques. | Procedure or surgery | Control group (Without A-PRF) |
Primary outcome
Volumetric bone volume healing assessment
Time frame: Baseline, 6 and 12 month
Volumetric analysis of CBCT images will segment the defect in axial, sagittal, and coronal views. Bone volume will be measured in cubic millimeters (mm³) at pre-operative, 6-month, and 12-month follow-ups and compared between each other. Where 0 is - no periapical lesion/periapical lesion healed.
1 secondary outcome
Asessment of Ultrasound diagnostic accuracy for periapical lesion measurment
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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 Phase 2 study testing Apical surgery procedure using A-PRF and Apical surgery without using A-PRF in people with Periapical Lesions, run by Riga Stradins University at 1 site in Latvia.
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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. 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 Latvia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Volumetric bone volume healing assessment (time frame: Baseline, 6 and 12 month). 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 18 Dec 2024.