Randomized, controlled, clinical trial for evaluation of the influence of platelet rich fibrin (PRF) in combination with bone substitute materials in use for regeneration of extraction sockets

Authors
Category Primary study
Registry of TrialsGerman Clinical Trials Register
Year 2021
INTERVENTION: Intervention 1: Pre‐molars ‐ Control 1: unfilled, untreated socket Intervention 2: Pre‐molars: High‐RCF‐PRF Intervention 3: Pre‐molars ‐ test group 1: socket preservation (type I extraction sockets) or ridge preservation (type II extraction sockets) with bone substitute material Intervention 4: Pre‐molars ‐ test group 2: socket preservation (type I extraction sockets) or ridge preservation (type II extraction sockets) with bone substitute material + low‐RCF‐PRF Intervention 5: Molars ‐ Control 1: unfilled, untreated socket Intervention 6: Molars ‐ High‐RCF‐PRF Intervention 7: Molars ‐ test group 1: socket preservation (type I extraction sockets) or ridge preservation (type II extraction sockets) with bone substitute material Intervention 8: Molars ‐ test group 2: socket preservation (type I extraction sockets) or ridge preservation (type II extraction sockets) with bone substitute material + low‐RCF‐PRF CONDITION: Bone‐ and soft tissue regeneration after tooth extraction K08.1 ‐ Loss of teeth due to accident, extraction or local periodontal disease PRIMARY OUTCOME: Bone gain in augmented region planned for implantation; [3 months post‐augmentation] SECONDARY OUTCOME: ‐ soft tissue healing (score 1‐4) [7 days post‐augmentation]; ‐ implant survival [up to 6 months post‐implantation]; ‐ bone change in augmented region [3 months post‐augmentation]; ‐ histological evaluation of vital bone, residual bone substitute material, connective tissue [3 months post‐augmentation]; ‐ overall soft tissue healing [7 days post‐surgery]; ‐ Oral Health Impact Profile questionnaire (OHIP‐14) [pre‐/post‐surgery]; ‐ peri implant soft tissue and bone tissue changes [up to 6 months post‐implantation]; ‐ further complications [up to 9 months post‐augmentation]; ‐ implant‐bone connection in follow‐up according to radiological evaluation [up to 6 months post‐implantation] INCLUSION CRITERIA: ‐ informed consent ‐ tooth/teeth in need of extraction ‐ patients planed for dental restoration via implantation ‐ indication for socket preservation / ridge preservation ‐ patients is suitable for two‐timed intervention ‐ patient will follow study‐related requirements and guidelines
Epistemonikos ID: 1ef75fd812560332a3b547767f94acd90078dfd9
First added on: Dec 20, 2022