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

Primary Purpose

Cleft Lip and Palate

Status
Active
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Lip and Palate focused on measuring cleft lip and palate, split thickness flap, autogenous tooth bone graft

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Semmelweis University Department of Periodontology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

soft tissue healing
Healing of soft tissues was recorded via photo documentation.
complications
Every complication will be reported

Full Information

First Posted
July 21, 2023
Last Updated
September 25, 2023
Sponsor
Semmelweis University
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1. Study Identification

Unique Protocol Identification Number
NCT05971914
Brief Title
Alveolar Cleft Hard- and Soft Tissue Reconstruction With an Autogenous Tooth Derived Particulate Graft
Official Title
Alveolar Cleft Hard- and Soft Tissue Reconstruction With an Autogenous Tooth Derived Particulate Graft
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate
Keywords
cleft lip and palate, split thickness flap, autogenous tooth bone graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
no masking
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap
Intervention Description
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 Measure Information:
Title
Radiological volumetric measurements
Description
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 Outcome Measure Information:
Title
soft tissue healing
Description
Healing of soft tissues was recorded via photo documentation.
Time Frame
during the 6 months postoperatively
Title
complications
Description
Every complication will be reported
Time Frame
1, 14, 30 days and 3 and 6 months after surgeries.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Semmelweis University Department of Periodontology
City
Budapest
ZIP/Postal Code
1088
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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