Partial Maxillary Expansion With Post Grafting Expansion vs. Pre Full Maxillary Expansion in Secondary Alveolar Cleft
May 24, 2025 updated by: mohamed fakhry, Cairo University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Faculty of Dentistry Cairo University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Patients with unilateral cleft alveolus with in the mixed dentition stage No intraoral soft and hard tissue pathology No systemic condition that contraindicate grafting
Exclusion Criteria:
Local criteria:
- poor oral hygiene
- radiation therapy the head and neck cancers
Systemic criteria:
- immunity deficiency or hemorrhagic inherited diseases
- Bone pathology
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: pre grafting partial maxillary expansion with post grafting expansion
pregrafting partial maxillary expansion then grafting left bone to consolidate for 2 months followed by post grafting expansion till full arch alignment
|
pre grafting partial maxillary expansion then anterior iliac grafting followed by 2 months period for consolidation then post grafting expansion till full arch alignment
|
|
Active Comparator: pre grafting full maxillary expansion
pre grafting full maxillary expansion till full arch alignment then grafting and let bone to consolidate
|
pre grafting partial maxillary expansion then anterior iliac grafting followed by 2 months period for consolidation then post grafting expansion till full arch alignment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone volume change
Time Frame: 6 months
|
bone volume is measured to ensure successful grafting
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
presence of relapse of expansion
Time Frame: 8 months
|
detection of any relapse after removal of maxillary expanders
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Kaura 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 20, 2023
Primary Completion (Actual)
April 20, 2025
Study Completion (Actual)
April 20, 2025
Study Registration Dates
First Submitted
June 11, 2023
First Submitted That Met QC Criteria
July 4, 2023
First Posted (Actual)
July 12, 2023
Study Record Updates
Last Update Posted (Actual)
May 30, 2025
Last Update Submitted That Met QC Criteria
May 24, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 51853267
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.