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
Inclusion Criteria3
- Participants greater or equal to 18 years of age
- Participants who have been treatment planned for tooth extraction/s and implant placement at the same extraction site/s.
- Participants willing to give written informed consent and willing to participate in and comply with the investigation requirements.
Exclusion Criteria10
- Participants <18 years of age.
- Participants with acute infection at the target site or a surgical site located near infection.
- Pregnant or lactating women, or women of childbearing potential who are not willing to avoid becoming pregnant during the study.
- Participants who are concurrently enrolled in another clinical study, or who have or received an investigational device or drug within the past four (4) weeks.
- Participants with a history of a psychological illness or condition such as to interfere with the Participant's ability to understand the requirements of the study.
- Participants unwilling or unlikely, in the Principal Investigator’s opinion, to comply with the study follow-up.
- Participants who are undergoing or are to undergo an immunosuppressive therapy.
- Participants with active cancer.
- Participants who have received radiation therapy to the jaws.
- Participants taking any drugs shown to alter bone metabolism within the jaws (e.g., bisphosphonates).
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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