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

Cleft Lip and Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05971914
• Other study ID #: Cleftgraft-Semmelweis
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: September 2023
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: November 1, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

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.

Locations

Country	Name	City	State
Hungary	Semmelweis University Department of Periodontology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	soft tissue healing	Healing of soft tissues was recorded via photo documentation.	during the 6 months postoperatively
Secondary	complications	Every complication will be reported	1, 14, 30 days and 3 and 6 months after surgeries.