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

Semmelweis University

Status: Active, not recruiting

Conditions: Cleft Lip and Palate

Treatments: Procedure: Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap

Study type: Interventional

Funder types: Other

Identifiers

NCT05971914

Cleftgraft-Semmelweis

Details and patient eligibility

About

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.

Enrollment: 8 estimated patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• children with alveolar cleft
• patient presented at least three deciduous teeth scheduled for extraction.

Exclusion criteria

• major relevant clinical diseases,
• systemic use of steroids,
• current or previous intravenous bisphosphonate treatment,
• acute infection at the operation site.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap

Experimental group

Description:

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.

Treatment:

Procedure: Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap