PET-B: Post Extraction use of TetraMax Part B (TMB). A comparator controlled clinical investigation comparing the bone healing capability of the investigational product "TetraMax plus BioOss" and the gold standard standard of care comparator "BioOssCollagen" (BioOssCol) for adults who have been treatment planned for tooth extraction/s and implant placement at the same extraction site/s.
PET-B: Post Extraction use of TetraMax Part B (TMB).. A comparator controlled clinical investigation comparing the bone healing capability of the investigational product "TetraMax plus BioOss" and the gold standard standard of care comparator "BioOssCollagen" (BioOssCol), for adults who have been treatment planned for tooth extraction/s and implant placement at the same extraction site/s.
Tetratherix Technology Pty Ltd
43 participants
Aug 19, 2019
Interventional
Conditions
Summary
This is a two-stage clinical investigation. Stage 1, an open label safety run-in investigation of the first three participants, who received open-label TetraMax in combination with BioOss (TMB) has been successfully completed. The first nine participants of stage 2 (randomisation) have received the IP/control product and are currently undergoing follow-up.
Eligibility
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Interventions
Single application of experimental device - TetraMax-B (TMB) or comparator control device (BioOss Collagen granules) by direct injection into the post-extraction dental socket. The approximate duration of the interventional procedure is 2 hours. All devices will be administered by an experienced dental implant surgeon and specialist periodontist. A maximum of 0.7ml of investigational product (TMB) (40% TetraMax 60% BioOss granules) will be applied. A maximum of 2.5ml of comparator control device BioOss Collagen will be applied. Total amount applied is dependent of dental socket dimensions.
Locations(1)
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ACTRN12619001124123