Cleft Lip and/or PalateIDONCT07578207
Tooth-borne Interdental Distraction Osteogenesis Along Arch Curvature for Wide Alveolar Clefts Reduction
A study testing Tooth borne Interdental distraction appliance with mini hyrax screw in people with Cleft Lip and/or Palate and Distraction of Bone, run by Ain Shams University at 1 site in Egypt.
Trial summary
This clinical study provided a modified simple and small appliance for reduction of wide alveolar clefts in cleft lip and palate patients, making the grafting procedure of better prognosis and increase its success rate. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Cleft Lip and/or Palate, Distraction of Bone
- What is being tested?
- Tooth borne Interdental distraction appliance with mini hyrax screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2018to 1 Jan 2022
- 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 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with ages ranging from 12 to 25 years old
- Patients with repaired cleft lip and / or palate.
- Patients with wide alveolar clefts more than 6 mm.
- Patients with median facial clefts, absent premaxilla.
- Patients who had previous failed grafting.
Who cannot join
- Patients with contraindications to general anaesthesia and surgery.
- Patients with syndromic cleft lip and palate.
- Patients with very bad oral hygiene.
- Vulnerable groups.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Orthodontics, Faculty of Dentistry, Ain Shams University Cairo, Abbaseya, Egypt
Cairo, 11566
About this study
Official title: A New Device for Interdental Distraction Osteogenesis for Management of Wide Alveolar Clefts
This clinical study provided a modified simple and small appliance for reduction of wide alveolar clefts in cleft lip and palate patients, making the grafting procedure of better prognosis and increase its success rate.
Read the detailed description
Along the journey of treatment of cleft patients, secondary autogenous alveolar bone grafting is the technique basically used for cleft alveolus and palate repair during mixed dentition stage, in order to create bone support for teeth adjacent to the cleft, making a bone matrix through which teeth in the line of the cleft can erupt, re-stabilize alveolar process contour and maxillary segments. In cases with wide alveolar clefts, more than the width of a maxillary canine, failure of this procedure is usually encountered. So, a further step prior to grafting procedure can be done in an attempt to reduce cleft width to enhance success of future grafting.
Distraction osteogenesis (DO) which is a procedure of growing new bone by mechanical stretching of the ordinary pre-existing vascularized bone tissue by a distraction device, where both segments of new alveolar bone as well as attached gingiva are formed can be used here to aid in minimizing cleft width.
The aim of this study was to introduce a new custom-made tooth-borne distractor that could provide 3D control upon using interdental distraction osteogenesis (IDO) with a posterior segment transport anteriorly along curvature of the arch through creating a controlled fracture, then applying this distractor device carrying a bone transport segment forward, decreasing the cleft width anteriorly with another benefit of leaving behind regenerated bone and attached gingiva posteriorly.
- Conditions
- Cleft Lip and/or Palate, Distraction of Bone
- Being tested
- Tooth borne Interdental distraction appliance with mini hyrax screw
- Keywords
- Alveolar cleft, Interdental distraction osteogenesis (IDO), Tooth-borne distractor, Cone beam computed tomography (CBCT)
- Medical subject headings
- Diastasis, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth borne Interdental distraction appliance with mini hyrax screwDevice
Also called Tooth borne alveolar distractor, Buccal mini hyrax distractor
This study aimed to provide a new design of a tooth-borne, custom-made distractor that could be easily constructed and rigid enough for controlled segment transport.
After cases' selection, arch expansion was done first.
Following expansion, preparation of the osteotomy site was done, through inducing root divergence at site of interdental osteotomy.
Osteotomies were performed under general anesthesia using piezo-surgery, there were 2 osteotomies in a L-shape; interdental vertical osteotomy mesial to 1st molar and a horizontal one above apices of teeth in the transport segment.
The distraction protocol was a latency period of 7 days, after which appliance activation started with a distraction rate of 0.4 mm/day with a rhythm of twice daily.
Activation proceeded till teeth at the edge of the cleft came into contact. Then the appliance was fixed in place for a 3 months consolidation period.
| Study group | Role | What they receive |
|---|---|---|
| Tooth borne interdental distraction along arch curvature appliance | Experimental | Patients eligible to the study were prepared to receive interdental distraction osteogenesis. The appliance was custom made for each patient. It is made up of orthodontic bands, labial, palatal stainless steel 0.9mm arches and micro expander screw soldered to the first permanent molar and to the first premolar in the transport segment . Receives: Device: Tooth borne Interdental distraction appliance with mini hyrax screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of width of alveolar cleft and oronasal fistula
Reduction or even closure of the wide interdental alveolar defect and the oronasal fistula measured on CBCT radiograph
Measured: 2-3 months
Secondary outcomes (3)
Dental changes with distraction
Amount of dental tipping that occurred with distraction forces measured on CBCT radiograph
Measured: 2-3 months
Quality of distracted bone
Measurement of bone radio density in Hounsfield Unit from CBCT
Measured: 3-6 months
Loss of anchorage with distraction forces
Amount of distal movement of anchor molar of the assembly as a side effect of the mesial distraction forces measured on CBCT radiograph
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start15 Jan 2018
- Primary completion12 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and/or PalateStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578207
- Sponsor's protocol ID
- FDASU-RecM121715
- Acronym
- IDO
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 11 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Device for Interdental Distraction Osteogenesis for Management of Wide Alveolar Clefts
- ClinicalTrials.gov ID
- NCT07578207
- Acronym / sponsor ID
- IDO / FDASU-RecM121715
- Conditions
- Cleft Lip and/or Palate, Distraction of Bone
- Keywords
- Alveolar cleft, Interdental distraction osteogenesis (IDO), Tooth-borne distractor, Cone beam computed tomography (CBCT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 11 May 2026 (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.
This clinical study provided a modified simple and small appliance for reduction of wide alveolar clefts in cleft lip and palate patients, making the grafting procedure of better prognosis and increase its success rate.
Detailed description
Along the journey of treatment of cleft patients, secondary autogenous alveolar bone grafting is the technique basically used for cleft alveolus and palate repair during mixed dentition stage, in order to create bone support for teeth adjacent to the cleft, making a bone matrix through which teeth in the line of the cleft can erupt, re-stabilize alveolar process contour and maxillary segments. In cases with wide alveolar clefts, more than the width of a maxillary canine, failure of this procedure is usually encountered. So, a further step prior to grafting procedure can be done in an attempt to reduce cleft width to enhance success of future grafting.
Distraction osteogenesis (DO) which is a procedure of growing new bone by mechanical stretching of the ordinary pre-existing vascularized bone tissue by a distraction device, where both segments of new alveolar bone as well as attached gingiva are formed can be used here to aid in minimizing cleft width.
The aim of this study was to introduce a new custom-made tooth-borne distractor that could provide 3D control upon using interdental distraction osteogenesis (IDO) with a posterior segment transport anteriorly along curvature of the arch through creating a controlled fracture, then applying this distractor device carrying a bone transport segment forward, decreasing the cleft width anteriorly with another benefit of leaving behind regenerated bone and attached gingiva posteriorly.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tooth borne interdental distraction along arch curvature appliance | Experimental | Device: Tooth borne Interdental distraction appliance with mini hyrax screwPatients eligible to the study were prepared to receive interdental distraction osteogenesis. The appliance was custom made for each patient. It is made up of orthodontic bands, labial, palatal stainless steel 0.9mm arches and micro expander screw soldered to the first permanent molar and to the first premolar in the transport segment . |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with ages ranging from 12 to 25 years old
- Patients with repaired cleft lip and / or palate.
- Patients with wide alveolar clefts more than 6 mm.
- Patients with median facial clefts, absent premaxilla.
- Patients who had previous failed grafting.
Key exclusion criteria (4 listed)
- Patients with contraindications to general anaesthesia and surgery.
- Patients with syndromic cleft lip and palate.
- Patients with very bad oral hygiene.
- Vulnerable groups.
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 |
|---|---|---|
| Tooth borne Interdental distraction appliance with mini hyrax screwAlso: Tooth borne alveolar distractor, Buccal mini hyrax distractorThis study aimed to provide a new design of a tooth-borne, custom-made distractor that could be easily constructed and rigid enough for controlled segment transport. After cases' selection, arch expansion was done first. Following expansion, preparation of the osteotomy site was done, through inducing root divergence at site of interdental osteotomy. Osteotomies were performed under general anesthesia using piezo-surgery, there were 2 osteotomies in a L-shape; interdental vertical osteotomy mesial to 1st molar and a horizontal one above apices of teeth in the transport segment. The distraction protocol was a latency period of 7 days, after which appliance activation started with a distraction rate of 0.4 mm/day with a rhythm of twice daily. Activation proceeded till teeth at the edge of the cleft came into contact. Then the appliance was fixed in place for a 3 months consolidation period. | Device | Tooth borne interdental distraction along arch curvature appliance |
Primary outcome
Reduction of width of alveolar cleft and oronasal fistula
Time frame: 2-3 months
Reduction or even closure of the wide interdental alveolar defect and the oronasal fistula measured on CBCT radiograph
3 secondary outcomes
Dental changes with distraction
Time frame: 2-3 months
Quality of distracted bone
Time frame: 3-6 months
Loss of anchorage with distraction forces
Time frame: 2-3 months
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 11 May 2026.
- Individual participant dataSharing planned: No
Related trials for Cleft Lip and/or Palate
Recruiting
Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery
Orofacial Clefts, Cleft Lip and Palate
Not yet recruiting
Early Intervention in Infants With Unrepaired Cleft Palate: Language, Palatal Function, and Articulation.
Cleft Lip and Cleft Palate, Cleft Lip Palate
Not yet recruiting
Effects of AlignBabyCleft (ABaCleft)
Cleft Lip, Cleft Palate
RecruitingObservational study
Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and/or Palate
Kallmann Syndrome, Hypogonadotropic Hypogonadism
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 Tooth borne Interdental distraction appliance with mini hyrax screw in people with Cleft Lip and/or Palate and Distraction of Bone, run by Ain Shams University at 1 site in Egypt.
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 5 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: finished, as of the sponsor's last update on 11 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 1 site in Egypt. 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?
Reduction of width of alveolar cleft and oronasal fistula (time frame: 2-3 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 11 May 2026.