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

N/AUnknownNCT05971914

Semmelweis University8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cleft Lip and Palate

Interventions

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

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.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Semmelweis University Department of Periodontology

Budapest, Hungary

Outcomes

Primary Outcomes

Radiological volumetric measurements

Volumetric measurements will be conducted after the healing period. On prealigned pre- and postoperative CBCT cross-sections, linear measurements and volumetric measurements will be taken parallel to a reference base to determine the width of the surgical area.

Time frame: 6 months

Secondary Outcomes

soft tissue healing

Healing of soft tissues was recorded via photo documentation.

Time frame: during the 6 months postoperatively

complications

Every complication will be reported

Time frame: 1, 14, 30 days and 3 and 6 months after surgeries.

Data from ClinicalTrials.gov

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