Apical Periodontal Cyst, Apical Periodontitis
Conditions
Brief 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.
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).
Interventions
PROCEDUREEndodontic Microsurgery
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.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
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 * Hepatitis B or C * Systemic disease (osteoporosis, diabetes…)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of peri-apical bone healing | 1 year | Amount of periapical bone healing in time: measured with Cone Beam Computed Tomography (CBCT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient related outcomes | 7 days | Pain assessed with a Visual Analogue Scale ranging from 0 to 10 each day during the first 7 days post-op. |
| Bone or scar tissue healing | 1 year | 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. |
| Success & survival rate | 1 year | Success & survival rate |
| Dentinal defects | 1 year | 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. |
Countries
Belgium
Contacts
Primary ContactNastaran Meschi, PhD
Backup ContactJoëy d'Hoop, DDS
Outcome results
None listed