Alveolar CleftBBID-WACNCT07306429
Evaluation of the Efficiency of Bone Born Intra Oral Distractor for Closure of Wide Alveolar Cleft
A study testing Bone-borne Intra oral distractor in people with Alveolar Cleft and Distraction of Bone, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
The study aimed to determine efficiency of Bone-Born Intraoral Distractor on wide Alveolar cleft patients Read more about this study
- Who is it for?
- Ages 7 to 20 years
- Conditions the study is for
- Alveolar Cleft, Distraction of Bone
- What is being tested?
- Bone-borne Intra oral distractor
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Mar 2023to 1 Dec 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 7 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with wide alveolar clefts more than 8ml either unilateral or bilateral or median facial cleft.
- Patients who had previous failed grafting also may be included.
- Age range of patients 7-20 years old, with no gender prediction, able to read and sign the informed consent (parents)
- Patients with median facial clefts.
Who cannot join
- Narrow alveolar cleft
- Syndromic patients.
- Oral soft tissues defects, inflammation, infections and bone metabolism disturbance.
- Allergy to titanium implant.
- Patient with systemic disease and immunocompromised patient.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of oral and dental medicine for Girls AlAzhar University
Cairo, Cairo Governorate, 12345
About this study
The study aimed to determine efficiency of Bone-Born Intraoral Distractor on wide Alveolar cleft patients
Read the detailed description
Stereographic models were used for construction of bone-born custom-made intraoral distractor according to the inclusion and exclusion criteria, followed up to measure and determine the efficiency of the distractor
- Conditions
- Alveolar Cleft, Distraction of Bone
- Being tested
- Bone-borne Intra oral distractor
- Keywords
- Alveolar Cleft, Bone Distraction
- Medical subject headings
- Diastasis, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone-borne Intra oral distractorDevice
Evaluation of the efficiency of the Bone-Borne Intraoral distractors on wide Alveolar cleft
| Study group | Role | What they receive |
|---|---|---|
| Bone-Borne Intra-oral distractor | Experimental | Surgeries to fix the device were conducted under GA. Then latency period of seven days was applied. Activation was 0.5 mm twice a day. The transport segment touched the docking site then the Consolidation period is achieved. Follow up for 6 months. Receives: Device: Bone-borne Intra oral distractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alveolar cleft defect area measured by cone-beam computed tomography (CBCT) (minimum value: 0 mm²; no predefined maximum value; lower values indicate better outcome)
The alveolar cleft defect area will be quantitatively measured using cone-beam computed tomography (CBCT). Preoperative and postoperative CBCT scans will be superimposed to calculate the change in defect area following distraction osteogenesis.
Measured: 6 months postoperative follow up
Change in tooth mobility assessed using Miller's Tooth Mobility Index (minimum score: 0; maximum score: 3; higher scores indicate worse mobility)
Tooth mobility will be clinically evaluated using Miller's Tooth Mobility Index to detect and grade the degree of mobility before and after treatment.
Measured: 6 months postoperative follow up
Vitality of the transported bone segment assessed by clinical vitality indicators after transport distraction osteogenesis (binary outcome: viable / non-viable; viable outcome indicates better result)
Vitality of the transported disk after transport distraction osteogenesis is measured through clinical indicators as No infection, No pain or inflammation, Stable transported segment, Successful consolidation phase.
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start14 Mar 2023
- Primary completion29 Jun 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar CleftStudies 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
- stereographic models were used for construction of bone-borne custom-made intraoral distractor
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hanaa Elmorsy, Faculty of Dental Medicine for Girls
- Investigators
- Hanaa Elmorsy, Assis.Lec, Study chair, Assistant lecturer of OMFs department Azhar UniversitySusan H Abdel Hakim, professor, Study director, Professor of OMFs department azhar universityWael Shawkat, Consultant, Study director, Head of the department at the Health Insurance HospitalFatema khalifa, Assist.Prof, Study director, Assistant Professor of OMFs Azhar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306429
- Sponsor's protocol ID
- ORSUR-10
- Acronym
- BBID-WAC
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Detailed Protocol
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Bone Born Intra Oral Distractor for Closure of Wide Alveolar Cleft
- ClinicalTrials.gov ID
- NCT07306429
- Acronym / sponsor ID
- BBID-WAC / ORSUR-10
- Conditions
- Alveolar Cleft, Distraction of Bone
- Keywords
- Alveolar Cleft, Bone Distraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 29 Jun 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 29 Dec 2025 (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 study aimed to determine efficiency of Bone-Born Intraoral Distractor on wide Alveolar cleft patients
Detailed description
Stereographic models were used for construction of bone-born custom-made intraoral distractor according to the inclusion and exclusion criteria, followed up to measure and determine the efficiency of the distractor
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- stereographic models were used for construction of bone-borne custom-made intraoral distractor
| Arm | Type | Receives |
|---|---|---|
| Bone-Borne Intra-oral distractor | Experimental | Device: Bone-borne Intra oral distractorSurgeries to fix the device were conducted under GA. Then latency period of seven days was applied. Activation was 0.5 mm twice a day. The transport segment touched the docking site then the Consolidation period is achieved. Follow up for 6 months. |
Who may qualify
- Ages
- 7 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with wide alveolar clefts more than 8ml either unilateral or bilateral or median facial cleft.
- Patients who had previous failed grafting also may be included.
- Age range of patients 7-20 years old, with no gender prediction, able to read and sign the informed consent (parents)
- Patients with median facial clefts.
Key exclusion criteria (5 listed)
- Narrow alveolar cleft
- Syndromic patients.
- Oral soft tissues defects, inflammation, infections and bone metabolism disturbance.
- Allergy to titanium implant.
- Patient with systemic disease and immunocompromised patient.
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 |
|---|---|---|
| Bone-borne Intra oral distractorEvaluation of the efficiency of the Bone-Borne Intraoral distractors on wide Alveolar cleft | Device | Bone-Borne Intra-oral distractor |
Primary outcome
Change in alveolar cleft defect area measured by cone-beam computed tomography (CBCT) (minimum value: 0 mm²; no predefined maximum value; lower values indicate better outcome)
Time frame: 6 months postoperative follow up
The alveolar cleft defect area will be quantitatively measured using cone-beam computed tomography (CBCT). Preoperative and postoperative CBCT scans will be superimposed to calculate the change in defect area following distraction osteogenesis.
Change in tooth mobility assessed using Miller's Tooth Mobility Index (minimum score: 0; maximum score: 3; higher scores indicate worse mobility)
Time frame: 6 months postoperative follow up
Tooth mobility will be clinically evaluated using Miller's Tooth Mobility Index to detect and grade the degree of mobility before and after treatment.
Vitality of the transported bone segment assessed by clinical vitality indicators after transport distraction osteogenesis (binary outcome: viable / non-viable; viable outcome indicates better result)
Time frame: 6 months follow up
Vitality of the transported disk after transport distraction osteogenesis is measured through clinical indicators as No infection, No pain or inflammation, Stable transported segment, Successful consolidation phase.
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 7 Jan 2026.
- Individual participant dataSharing planned: No. Detailed Protocol
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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.
Hanaa Elmorsy, Assis.Lec study chair
Assistant lecturer of OMFs department Azhar University
Susan H Abdel Hakim, professor study director
Professor of OMFs department azhar university
Wael Shawkat, Consultant study director
Head of the department at the Health Insurance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone-borne Intra oral distractor in people with Alveolar Cleft and Distraction of Bone, run by Faculty of Dental Medicine for Girls 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 4 inclusion and 5 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 7 Jan 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?
Change in alveolar cleft defect area measured by cone-beam computed tomography (CBCT) (minimum value: 0 mm²; no predefined maximum value; lower values indicate better outcome) (time frame: 6 months postoperative follow up). The study lists 3 primary outcomes in all. 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 7 Jan 2026.