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

Not Applicable

Active, not recruiting

• Conditions: Cleft Lip and Palate
• Interventions: Procedure: Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap

• Registration Number: NCT05971914
• Lead Sponsor: Semmelweis University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-12
• Study First Submitted: 2023-07-21
• Study First Submitted QC: 2023-08-01
• Study First Posted: 2023-08-02
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-26
• Primary Completion: 2023-10-30
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap	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.

Primary Outcome Measures

Name	Time	Method
Radiological volumetric measurements	6 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Semmelweis University Department of Periodontology; 🇭🇺 Budapest, Hungary