NCT05971914

Alveolar Cleft Hard- and Soft Tissue Reconstruction With an Autogenous Tooth Derived Particulate Graft

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Accepted

Summary

The present study aims at clinical and radiographic evaluation of the safety and efficacy of Bonmaker ATB powder combined with a novel split thickness papilla curtain flap in the treatment of alveolar cleft defects.

Conditions

• Cleft Lip and Palate

Interventions

Type	Name	Description
PROCEDURE	Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap	Extracted deciduous teeth were prepared immediately after removal according to the manufacturer's instructions with the Bonmaker® device. Ready to use autogenous tooth bone graft (ATB) was mixed with fibrin glue in 3D planned and printed plastic cuvettes to obtain a sticky graft closely matching the shape and extent of the bony defect. The preshaped sticky ATB graft was inserted and compacted in the cleft defect. Subsequently, the tension-free split thickness flap was repositioned by shifting all buccal surgical papillae mesially to the adjacent or the second adjacent interproximal space, depending on the horizontal extent of the cleft.

Timeline

• Start date: 2021-10-12
• Primary completion: 2023-10-30
• Completion: 2023-11-01
• First posted: 2023-08-02
• Last updated: 2023-09-26

Locations

1 site across 1 country: Hungary