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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001124123

Acronym

PET-B

Enrollment

Registered

2019-08-12

Start date

2019-08-19

Completion date

2023-03-22

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• 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 criteria

• 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).

Outcome results