Alveolar CleftNCT05941988
Partial Maxillary Expansion With Post Grafting Expansion vs. Pre Full Maxillary Expansion in Secondary Alveolar Cleft
A study testing pre grafting partial maxillary expansion with post grafting expansion in people with Alveolar Cleft, run by Cairo University at 1 site in Egypt.
Trial summary
Intermediate grafting with both pre- and post- grafting maxillary expansion with time span after grafting 6-8 weeks for consolidation and final retention for 3 months after finalization of expansion will get the advantages of both techniques combined. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Cleft
- What is being tested?
- pre grafting partial maxillary expansion with post grafting expansion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2023to 20 Apr 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 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with unilateral cleft alveolus with in the mixed dentition stage No intraoral soft and hard tissue pathology No systemic condition that contraindicate grafting
Who cannot join
- Local criteria:
- poor oral hygiene
- radiation therapy the head and neck cancers
- Systemic criteria:
- immunity deficiency or hemorrhagic inherited diseases
- Bone pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pre Grafting Partial Maxillary Expansion With Post Grafting Expansion Versus Pre Grafting Full Maxillary Expansion on the Stability and Bone Resorption in Secondary Unilateral Alveolar Cleft Grafting
Intermediate grafting with both pre- and post- grafting maxillary expansion with time span after grafting 6-8 weeks for consolidation and final retention for 3 months after finalization of expansion will get the advantages of both techniques combined.
Read the detailed description
Secondary alveolar bone grafting (SABG) is an essential step in the overall management of Patients with cleft lip and palate (CLP). The numerous advantages of this procedure have been reported in the literature. However, resorption of the bone graft is a common situation, and the success of alveolar bone grafting (ABG) depends on several factors . The periodontal health of the surrounding graft tissues, the experience and ability of the surgeon and the timing of surgery are shown to be the most important factors determining success. Failure to rehabilitate the alveolar cleft may give rise to a variety of problems, including oronasal fistula, fluid reflux, speech pathology, impaired tooth eruption, lack of bone support for the anterior teeth, dental crowding, periodontal recession and eventual loss of teeth, and maxillary and facial asymmetry . Lack of alveolar bone also limits orthodontic treatment and/or prosthodontics rehabilitation. Post graft stimulation of maturation through remodeling of the graft is extremely important and is provided primarily by natural tooth eruption. Thus, the ideal time period for SABG is shown as to be the mixed dentition stage (9-12 years), just before the eruption of the permanent canine in line with the cleft. Timing of maxillary expansion in patients with cleft lip and palate is debated. Proponents of expanding the maxilla prior to secondary alveolar bone grafting state it is beneficial to align the segments prior to bone grafting better access for placement of the graft and working facility during surgery, However more recent literature shows maxillary expansion after secondary bone grafting is possible Advocates of expansion following grafting cite the advantages that bone consolidation is improved when the graft is placed under a dynamic load during healing and that there is a smaller soft tissue defect to close, less difficulty procuring an adequate volume of bone, and a narrower defect, which will regenerate bone more quickly and less possibility to induce oronasal fistula during maxillary expansion the study will change the concept of alveolar bone grafting in relation to maxillary expansion .just getting 5 mm minimal between two cleft edges and 2/3 of canine or lateral root has been formed and thin bone separate tooth from cleft defect the graft could be done
- Conditions
- Alveolar Cleft
- Being tested
- pre grafting partial maxillary expansion with post grafting expansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre grafting partial maxillary expansion with post grafting expansionProcedure or surgery
pre grafting partial maxillary expansion then anterior iliac grafting followed by 2 months period for consolidation then post grafting expansion till full arch alignment
| Study group | Role | What they receive |
|---|---|---|
| pre grafting partial maxillary expansion with post grafting expansion | Experimental | pregrafting partial maxillary expansion then grafting left bone to consolidate for 2 months followed by post grafting expansion till full arch alignment Receives: Procedure: pre grafting partial maxillary expansion with post grafting expansion |
| pre grafting full maxillary expansion | Active comparator | pre grafting full maxillary expansion till full arch alignment then grafting and let bone to consolidate Receives: Procedure: pre grafting partial maxillary expansion with post grafting expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone volume change
bone volume is measured to ensure successful grafting
Measured: 6 months
Secondary outcomes (1)
presence of relapse of expansion
detection of any relapse after removal of maxillary expanders
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start20 Feb 2023
- Primary completion20 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alveolar CleftStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed fakhry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941988
- Sponsor's protocol ID
- 51853267
- Status last verified
- May 2025
- First submitted
- 11 Jun 2023
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Uzel A, Benlidayi ME, Kurkcu M, Kesiktas E. The Effects of Maxillary Expansion on Late Alveolar Bone Grafting in Patients With Unilateral Cleft Lip and Palate. J Oral Maxillofac Surg. 2019 Mar;77(3):607-614. doi: 10.1016/j.joms.2018.07.022. Epub 2018 Jul 27.
PubMed 30138625Kaura AS, Srinivasa DR, Kasten SJ. Optimal Timing of Alveolar Cleft Bone Grafting for Maxillary Clefts in the Cleft Palate Population. J Craniofac Surg. 2018 Sep;29(6):1551-1557. doi: 10.1097/SCS.0000000000004680.
PubMed 29916970
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre Grafting Partial Maxillary Expansion With Post Grafting Expansion Versus Pre Grafting Full Maxillary Expansion on the Stability and Bone Resorption in Secondary Unilateral Alveolar Cleft Grafting
- ClinicalTrials.gov ID
- NCT05941988
- Acronym / sponsor ID
- 51853267
- Conditions
- Alveolar Cleft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 12 Jul 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.
Intermediate grafting with both pre- and post- grafting maxillary expansion with time span after grafting 6-8 weeks for consolidation and final retention for 3 months after finalization of expansion will get the advantages of both techniques combined.
Detailed description
Secondary alveolar bone grafting (SABG) is an essential step in the overall management of Patients with cleft lip and palate (CLP). The numerous advantages of this procedure have been reported in the literature. However, resorption of the bone graft is a common situation, and the success of alveolar bone grafting (ABG) depends on several factors . The periodontal health of the surrounding graft tissues, the experience and ability of the surgeon and the timing of surgery are shown to be the most important factors determining success. Failure to rehabilitate the alveolar cleft may give rise to a variety of problems, including oronasal fistula, fluid reflux, speech pathology, impaired tooth eruption, lack of bone support for the anterior teeth, dental crowding, periodontal recession and eventual loss of teeth, and maxillary and facial asymmetry . Lack of alveolar bone also limits orthodontic treatment and/or prosthodontics rehabilitation. Post graft stimulation of maturation through remodeling of the graft is extremely important and is provided primarily by natural tooth eruption. Thus, the ideal time period for SABG is shown as to be the mixed dentition stage (9-12 years), just before the eruption of the permanent canine in line with the cleft. Timing of maxillary expansion in patients with cleft lip and palate is debated. Proponents of expanding the maxilla prior to secondary alveolar bone grafting state it is beneficial to align the segments prior to bone grafting better access for placement of the graft and working facility during surgery, However more recent literature shows maxillary expansion after secondary bone grafting is possible Advocates of expansion following grafting cite the advantages that bone consolidation is improved when the graft is placed under a dynamic load during healing and that there is a smaller soft tissue defect to close, less difficulty procuring an adequate volume of bone, and a narrower defect, which will regenerate bone more quickly and less possibility to induce oronasal fistula during maxillary expansion the study will change the concept of alveolar bone grafting in relation to maxillary expansion .just getting 5 mm minimal between two cleft edges and 2/3 of canine or lateral root has been formed and thin bone separate tooth from cleft defect the graft could be done
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre grafting partial maxillary expansion with post grafting expansion | Experimental | Procedure: pre grafting partial maxillary expansion with post grafting expansionpregrafting partial maxillary expansion then grafting left bone to consolidate for 2 months followed by post grafting expansion till full arch alignment |
| pre grafting full maxillary expansion | Active comparator | Procedure: pre grafting partial maxillary expansion with post grafting expansionpre grafting full maxillary expansion till full arch alignment then grafting and let bone to consolidate |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with unilateral cleft alveolus with in the mixed dentition stage No intraoral soft and hard tissue pathology No systemic condition that contraindicate grafting
Key exclusion criteria (6 listed)
- Local criteria:
- immunity deficiency or hemorrhagic inherited diseases
- Bone pathology
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 |
|---|---|---|
| pre grafting partial maxillary expansion with post grafting expansionpre grafting partial maxillary expansion then anterior iliac grafting followed by 2 months period for consolidation then post grafting expansion till full arch alignment | Procedure or surgery | pre grafting full maxillary expansion, pre grafting partial maxillary expansion with post grafting expansion |
Primary outcome
Bone volume change
Time frame: 6 months
bone volume is measured to ensure successful grafting
1 secondary outcome
presence of relapse of expansion
Time frame: 8 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 30 May 2025.
- Background: PubMed 30138625Uzel A, Benlidayi ME, Kurkcu M, Kesiktas E. The Effects of Maxillary Expansion on Late Alveolar Bone Grafting in Patients With Unilateral Cleft Lip and Palate. J Oral Maxillofac Surg. 2019 Mar;77(3):607-614. doi: 10.1016/j.joms.2018.07.022. Epub 2018 Jul 27.
- Background: PubMed 29916970Kaura AS, Srinivasa DR, Kasten SJ. Optimal Timing of Alveolar Cleft Bone Grafting for Maxillary Clefts in the Cleft Palate Population. J Craniofac Surg. 2018 Sep;29(6):1551-1557. doi: 10.1097/SCS.0000000000004680.
- Individual participant dataSharing planned: Undecided
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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 pre grafting partial maxillary expansion with post grafting expansion in people with Alveolar Cleft, run by Cairo 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 1 inclusion and 6 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 30 May 2025. 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?
Bone volume change (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05941988, which also lists 2 linked publications.
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 30 May 2025.