Periapical Periodontitis
Conditions
Keywords
platelets
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.
Interventions
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient related outcomes | 7 days | Assessed with a Visual Analog Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient related outcomes | 7 days | Assessed with a questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bone or scar tissue healing | 4 years | Assessed with conebeam CT |
| Amount of periapical bone healing in time | 4 years | Assessed with conebeam CT and periapical radiography |
| Type of periapical tissue | 7 days | Assessed by biopsy |
| Dentinal defects | 1 day | Assessed with a LED light source |
| Timeframe in which the cortical bone plate closes | 1 year | Assessed with echography |
Countries
Belgium
Outcome results
None listed