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

Sponsor

Semmelweis University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05971914

Collaborator

(none)

Enrollment

Location

Arm

21.6

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cleft Lip and Palate	Procedure: Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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 caregiverEight 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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 12, 2021

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Semmelweis University Department of Periodontology	Budapest		Hungary	1088

Sponsors and Collaborators

Semmelweis University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Nagy Krisztián, Associate Professor, Semmelweis University

ClinicalTrials.gov Identifier:

NCT05971914

Other Study ID Numbers:

Cleftgraft-Semmelweis

First Posted:

Aug 2, 2023

Last Update Posted:

Aug 2, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. Nagy Krisztián, Associate Professor, Semmelweis University

cleft lip and palate

split thickness flap

autogenous tooth bone graft

Additional relevant MeSH terms:

Cleft Lip

Study Results

No Results Posted as of Aug 2, 2023