Cleft Palate ChildrenACROSTICNCT05331456
Alveolar Cleft Repair Using Osteoinductive Ceramics
A study testing Unilateral alveolar cleft repair in people with Cleft Palate Children and Cleft Alveolar Ridge, run by UMC Utrecht at 4 sites in Netherlands.
Trial summary
In this study, patients with unilateral cleft lip and palate are enrolled in a multicenter stepped wedge randomized trial ithat compares alveolar cleft closure using autologous bone harvested form the mandibular symphysis with an osteoinductive biphasic calcium phosphate putty. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cleft Palate Children, Cleft Alveolar Ridge, Cleft Lip and Palate
- What is being tested?
- Unilateral alveolar cleft repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 4 sitesNetherlands
- Study dates
- 1 Jun 2022to 1 Mar 2025
- 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
- No healthy volunteers
- Child
Who may be able to join
- unilateral alveolar cleft, early secondary alveolar cleft closure
Who cannot join
- cleft lip and palate in a syndromic context
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Amsterdam UMC
Amsterdam
UMC Groningen
Groningen
Radboud UMC
Nijmegen
UMC Utrecht
Utrecht
About this study
Official title: Alveolar Cleft Repair Using Osteoinductive Ceramics in Children With Unilateral Cleft Lip and Palate
In this study, patients with unilateral cleft lip and palate are enrolled in a multicenter stepped wedge randomized trial ithat compares alveolar cleft closure using autologous bone harvested form the mandibular symphysis with an osteoinductive biphasic calcium phosphate putty.
Read the detailed description
Rationale: Patients who undergo alveolar cleft grafting have to deal with postoperative pain and comorbidity due to harvesting of autologous bone.
Objective: To evaluate if using calcium phosphate based scaffolds for alveolar cleft grafting is as effective as the use of an autologous bone graft.
Study design: A 'stepped wedge' randomized controlled trial will be conducted by four centres.
Study population: Children between the ages of 8 to 12 years with a unilateral alveolar cleft.
Intervention: Study group undergoes alveolar cleft grafting with the use of a calcium phosphate based scaffold, the control group undergoes the same procedure, but with the use of an autologous chin bone graft.
Main study parameters/endpoints: Main study outcome is one year postoperative residual bone volume in the reconstructed alveolar cleft. Secondary objectives of importance are postoperative pain and eruption of the tooth adjacent to the cleft through the reconstructed area.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in the control group will undergo a procedure that is currently seen as the gold standard. Patients in the study group will undergo the exact same risks as the control group, except there is no risk for donor site morbidity and postoperative pain is significantly less. Postoperative clinical and radiological evaluation of both groups is according to current treatment standards.
- Being tested
- Unilateral alveolar cleft repair
- Keywords
- cleft palate, cleft lip, alveolar cleft, calcium phosphate ceramics, bone graft
- Medical subject headings
- Cleft Lip, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral alveolar cleft repairDevice
Early secondary alveolar cleft repair is performed in children with a unilateral alveolar cleft using eirther autologous bone or a calcium phosphate based putty
| Study group | Role | What they receive |
|---|---|---|
| Alveolar cleft repair using autologous bone from the mandibular symphysis | Other | Control group Receives: Device: Unilateral alveolar cleft repair |
| Alveolar cleft repair using a biphasic clacium phosphate putty | Other | Study group Receives: Device: Unilateral alveolar cleft repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone volume
One year postoperative residual bone volume
Measured: 1 year postoperatively
Secondary outcomes (2)
Postoperative pain
Postoperative pain on a 1 to 10 scale
Measured: Day 1 to 7 postoperatively
Canine eruption
Eruption of the canine (or lateral incisor) adjacent to the alevolar cleft
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Jun 2022
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Palate ChildrenStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped wedge cluster randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Ziekenhuis Groningen, Medisch Centrum Leeuwarden, Radboud University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Principal investigator, Nard Janssen, UMC Utrecht
- Investigators
- Nard Janssen, MD, DDS, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331456
- Sponsor's protocol ID
- NL75562.041.21
- Acronym
- ACROSTIC
- Status last verified
- May 2026
- First submitted
- 11 Apr 2022
- Last updated
- 8 May 2026
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Cleft Repair Using Osteoinductive Ceramics in Children With Unilateral Cleft Lip and Palate
- ClinicalTrials.gov ID
- NCT05331456
- Acronym / sponsor ID
- ACROSTIC / NL75562.041.21
- Keywords
- cleft palate, cleft lip, alveolar cleft, calcium phosphate ceramics, bone graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Academisch Ziekenhuis Groningen, Medisch Centrum Leeuwarden, Radboud University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 15 Apr 2022 (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.
In this study, patients with unilateral cleft lip and palate are enrolled in a multicenter stepped wedge randomized trial ithat compares alveolar cleft closure using autologous bone harvested form the mandibular symphysis with an osteoinductive biphasic calcium phosphate putty.
Detailed description
Rationale: Patients who undergo alveolar cleft grafting have to deal with postoperative pain and comorbidity due to harvesting of autologous bone.
Objective: To evaluate if using calcium phosphate based scaffolds for alveolar cleft grafting is as effective as the use of an autologous bone graft.
Study design: A 'stepped wedge' randomized controlled trial will be conducted by four centres.
Study population: Children between the ages of 8 to 12 years with a unilateral alveolar cleft.
Intervention: Study group undergoes alveolar cleft grafting with the use of a calcium phosphate based scaffold, the control group undergoes the same procedure, but with the use of an autologous chin bone graft.
Main study parameters/endpoints: Main study outcome is one year postoperative residual bone volume in the reconstructed alveolar cleft. Secondary objectives of importance are postoperative pain and eruption of the tooth adjacent to the cleft through the reconstructed area.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in the control group will undergo a procedure that is currently seen as the gold standard. Patients in the study group will undergo the exact same risks as the control group, except there is no risk for donor site morbidity and postoperative pain is significantly less. Postoperative clinical and radiological evaluation of both groups is according to current treatment standards.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Alveolar cleft repair using autologous bone from the mandibular symphysis | Other | Device: Unilateral alveolar cleft repairControl group |
| Alveolar cleft repair using a biphasic clacium phosphate putty | Other | Device: Unilateral alveolar cleft repairStudy group |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- unilateral alveolar cleft, early secondary alveolar cleft closure
Key exclusion criteria (1 listed)
- cleft lip and palate in a syndromic context
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 |
|---|---|---|
| Unilateral alveolar cleft repairEarly secondary alveolar cleft repair is performed in children with a unilateral alveolar cleft using eirther autologous bone or a calcium phosphate based putty | Device | Alveolar cleft repair using a biphasic clacium phosphate putty, Alveolar cleft repair using autologous bone from the mandibular symphysis |
Primary outcome
Bone volume
Time frame: 1 year postoperatively
One year postoperative residual bone volume
2 secondary outcomes
Postoperative pain
Time frame: Day 1 to 7 postoperatively
Canine eruption
Time frame: 1 year postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- 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.
Nard Janssen, MD, DDS, PhD principal investigator
UMC Utrecht
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral alveolar cleft repair in people with Cleft Palate Children and Cleft Alveolar Ridge, run by UMC Utrecht at 4 sites in Netherlands.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bone volume (time frame: 1 year postoperatively). 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 8 May 2026.