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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cleft Lip and Palate

Intervention / Treatment
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* Procedure: Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Eight patients aged 8-12 years exhibiting uni- or bilateral alveolar cleft defects and oronasal fistulas underwent supra-, subgingival scaling and received individual oral hygiene instructions prior to surgery at the Department of Periodontology, Semmelweis University, Budapest, Hungary. Surgeries will be performed at the I. Department of Paediatrics, Semmelweis University, Budapest, Hungary between January 2021 and November 2021. The study was approved by the Semmelweis University Regional and Institutional Committee of Science and Research Ethics (Approval Number SE TUKEB x/2020). Patients is treated in accordance with the World Medical Association Declaration of Helsinki (version 2008). Surgical interventions are undertaken with the understanding and written consent of each subject's caregiver
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap<br>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. | Procedure: Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| soft tissue healing | Healing of soft tissues was recorded via photo documentation. | during the 6 months postoperatively | 
| complications | Every complication will be reported | 1, 14, 30 days and 3 and 6 months after surgeries. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cleft lip and palate, split thickness flap, autogenous tooth bone graft