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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05971914
Other study ID # Cleftgraft-Semmelweis
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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