Cleft Lip and PalateNCT05971914
Alveolar Cleft Hard- and Soft Tissue Reconstruction With an Autogenous Tooth Derived Particulate Graft
A study testing Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap in people with Cleft Lip and Palate, run by Semmelweis University at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteHungary
- Study dates
- 12 Oct 2021to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children with alveolar cleft
- patient presented at least three deciduous teeth scheduled for extraction.
Who cannot join
- major relevant clinical diseases,
- systemic use of steroids,
- current or previous intravenous bisphosphonate treatment,
- acute infection at the operation site.
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University Department of Periodontology
Budapest, 1088
About this study
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.
- Conditions
- Cleft Lip and Palate
- Being tested
- Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap
- Keywords
- cleft lip and palate, split thickness flap, autogenous tooth bone graft
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flapProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap | Experimental | 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. Receives: Procedure: Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
soft tissue healing
Healing of soft tissues was recorded via photo documentation.
Measured: during the 6 months postoperatively
complications
Every complication will be reported
Measured: 1, 14, 30 days and 3 and 6 months after surgeries.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start12 Oct 2021
- Primary completion30 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nagy Krisztián, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971914
- Sponsor's protocol ID
- Cleftgraft-Semmelweis
- Status last verified
- Sep 2023
- First submitted
- 21 Jul 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Cleft Hard- and Soft Tissue Reconstruction With an Autogenous Tooth Derived Particulate Graft
- ClinicalTrials.gov ID
- NCT05971914
- Acronym / sponsor ID
- Cleftgraft-Semmelweis
- Conditions
- Cleft Lip and Palate
- Keywords
- cleft lip and palate, split thickness flap, autogenous tooth bone graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap | Experimental | Procedure: Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flapExtracted 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children with alveolar cleft
- patient presented at least three deciduous teeth scheduled for extraction.
Key exclusion criteria (4 listed)
- major relevant clinical diseases,
- systemic use of steroids,
- current or previous intravenous bisphosphonate treatment,
- acute infection at the operation site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flapExtracted 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 or surgery | Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap |
Primary outcome
Radiological volumetric measurements
Time frame: 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.
2 secondary outcomes
soft tissue healing
Time frame: during the 6 months postoperatively
complications
Time frame: 1, 14, 30 days and 3 and 6 months after surgeries.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap in people with Cleft Lip and Palate, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological volumetric measurements (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.