RecruitingACTRN12619001124123

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.


Sponsor

Tetratherix Technology Pty Ltd

Enrollment

43 participants

Start Date

Aug 19, 2019

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When a tooth is removed and a dental implant is planned for the same site, the quality of bone healing in the gap is critical for the implant to succeed long-term. This study compares a new bone grafting product called TetraMax combined with BioOss (a well-established bone graft material) against the current gold standard dressing product BioOssCollagen, to see which leads to better bone healing after tooth extraction. Participants who need one or more teeth extracted and are planning to have implants placed at the same site are randomly assigned to one of the two approaches. The healing of the extraction socket is then monitored over time. This study follows a successful safety run-in phase and is now in its main comparison stage. You may be eligible if you are 18 or older, have been treatment-planned for tooth extraction and implant placement, and are willing to follow all study visits and requirements. People with active infection at the site, pregnant or breastfeeding women, those on immunosuppressive therapy, those with active cancer, and those taking medications known to affect bone healing (like bisphosphonates) are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 duratio

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)

West Perth Periodontics - West Perth

WA, Australia

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ACTRN12619001124123